Publications by authors named "Alexandre Biasi Cavalcanti"

84 Publications

Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial.

Trials 2021 Sep 1;22(1):582. Epub 2021 Sep 1.

Instituto Nacional de Cardiologia (INC), Rio de Janeiro, Rio de Janeiro, Brazil.

Background: Nut consumption has been related to improvements on cardiometabolic parameters and reduction in the severity of atherosclerosis mainly in primary cardiovascular prevention. The objective of this trial is to evaluate the effects of the Brazilian Cardioprotective Diet (DIeta CArdioprotetora Brasileira, DICA Br) based on consumption of inexpensive locally accessible foods supplemented or not with mixed nuts on cardiometabolic features in patients with previous myocardial infarction (MI).

Methods: DICA-NUTS study is a national, multicenter, randomized 16-week follow-up clinical trial. Patients over 40 years old with diagnosis of previous MI in the last 2 to 6 months will be recruited (n = 388). A standardized questionnaire will be applied to data collection and blood samples will be obtained. Patients will be allocated in two groups: Group 1: DICA Br supplemented with 30 g/day of mixed nuts (10 g of peanuts, 10 g of cashew, 10 g of Brazil nuts); and Group 2: only DICA Br. The primary outcome will consist of LDL cholesterol means (in mg/dL) after 16 weeks of intervention. Secondary outcomes will consist of other markers of lipid profile, glycemic profile, and anthropometric data.

Discussion: It is expected that DICA Br supplemented with mixed nuts have superior beneficial effects on cardiometabolic parameters in patients after a MI, when compared to DICA Br.

Trial Registration: ClinicalTrials.gov Identifier NCT03728127 . First register: November 1, 2018; Last update: June 16, 2021. World Health Organization Universal Trial Number (WHO-UTN): U1111-1259-8105.
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http://dx.doi.org/10.1186/s13063-021-05494-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411551PMC
September 2021

Resuscitation fluid practices in Brazilian intensive care units: a secondary analysis of Fluid-TRIPS.

Rev Bras Ter Intensiva 2021 Apr-Jun;33(2):206-218

Hospital Copa D'Or - Rio de Janeiro (RJ), Brasil.

Objective: To describe fluid resuscitation practices in Brazilian intensive care units and to compare them with those of other countries participating in the Fluid-TRIPS.

Methods: This was a prospective, international, cross-sectional, observational study in a convenience sample of intensive care units in 27 countries (including Brazil) using the Fluid-TRIPS database compiled in 2014. We described the patterns of fluid resuscitation use in Brazil compared with those in other countries and identified the factors associated with fluid choice.

Results: On the study day, 3,214 patients in Brazil and 3,493 patients in other countries were included, of whom 16.1% and 26.8% (p < 0.001) received fluids, respectively. The main indication for fluid resuscitation was impaired perfusion and/or low cardiac output (Brazil: 71.7% versus other countries: 56.4%, p < 0.001). In Brazil, the percentage of patients receiving crystalloid solutions was higher (97.7% versus 76.8%, p < 0.001), and 0.9% sodium chloride was the most commonly used crystalloid (62.5% versus 27.1%, p < 0.001). The multivariable analysis suggested that the albumin levels were associated with the use of both crystalloids and colloids, whereas the type of fluid prescriber was associated with crystalloid use only.

Conclusion: Our results suggest that crystalloids are more frequently used than colloids for fluid resuscitation in Brazil, and this discrepancy in frequencies is higher than that in other countries. Sodium chloride (0.9%) was the crystalloid most commonly prescribed. Serum albumin levels and the type of fluid prescriber were the factors associated with the choice of crystalloids or colloids for fluid resuscitation.
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http://dx.doi.org/10.5935/0103-507X.20210028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8275089PMC
September 2020

Association Between Administration of IL-6 Antagonists and Mortality Among Patients Hospitalized for COVID-19: A Meta-analysis.

JAMA 2021 08;326(6):499-518

Medanta-The Medicity, Institute of Liver Transplantation and Regenerative Medicine, Gurugram, India.

Importance: Clinical trials assessing the efficacy of IL-6 antagonists in patients hospitalized for COVID-19 have variously reported benefit, no effect, and harm.

Objective: To estimate the association between administration of IL-6 antagonists compared with usual care or placebo and 28-day all-cause mortality and other outcomes.

Data Sources: Trials were identified through systematic searches of electronic databases between October 2020 and January 2021. Searches were not restricted by trial status or language. Additional trials were identified through contact with experts.

Study Selection: Eligible trials randomly assigned patients hospitalized for COVID-19 to a group in whom IL-6 antagonists were administered and to a group in whom neither IL-6 antagonists nor any other immunomodulators except corticosteroids were administered. Among 72 potentially eligible trials, 27 (37.5%) met study selection criteria.

Data Extraction And Synthesis: In this prospective meta-analysis, risk of bias was assessed using the Cochrane Risk of Bias Assessment Tool. Inconsistency among trial results was assessed using the I2 statistic. The primary analysis was an inverse variance-weighted fixed-effects meta-analysis of odds ratios (ORs) for 28-day all-cause mortality.

Main Outcomes And Measures: The primary outcome measure was all-cause mortality at 28 days after randomization. There were 9 secondary outcomes including progression to invasive mechanical ventilation or death and risk of secondary infection by 28 days.

Results: A total of 10 930 patients (median age, 61 years [range of medians, 52-68 years]; 3560 [33%] were women) participating in 27 trials were included. By 28 days, there were 1407 deaths among 6449 patients randomized to IL-6 antagonists and 1158 deaths among 4481 patients randomized to usual care or placebo (summary OR, 0.86 [95% CI, 0.79-0.95]; P = .003 based on a fixed-effects meta-analysis). This corresponds to an absolute mortality risk of 22% for IL-6 antagonists compared with an assumed mortality risk of 25% for usual care or placebo. The corresponding summary ORs were 0.83 (95% CI, 0.74-0.92; P < .001) for tocilizumab and 1.08 (95% CI, 0.86-1.36; P = .52) for sarilumab. The summary ORs for the association with mortality compared with usual care or placebo in those receiving corticosteroids were 0.77 (95% CI, 0.68-0.87) for tocilizumab and 0.92 (95% CI, 0.61-1.38) for sarilumab. The ORs for the association with progression to invasive mechanical ventilation or death, compared with usual care or placebo, were 0.77 (95% CI, 0.70-0.85) for all IL-6 antagonists, 0.74 (95% CI, 0.66-0.82) for tocilizumab, and 1.00 (95% CI, 0.74-1.34) for sarilumab. Secondary infections by 28 days occurred in 21.9% of patients treated with IL-6 antagonists vs 17.6% of patients treated with usual care or placebo (OR accounting for trial sample sizes, 0.99; 95% CI, 0.85-1.16).

Conclusions And Relevance: In this prospective meta-analysis of clinical trials of patients hospitalized for COVID-19, administration of IL-6 antagonists, compared with usual care or placebo, was associated with lower 28-day all-cause mortality.

Trial Registration: PROSPERO Identifier: CRD42021230155.
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http://dx.doi.org/10.1001/jama.2021.11330DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8261689PMC
August 2021

TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE): protocol for a cluster-randomised clinical trial on adult general ICUs in Brazil.

BMJ Open 2021 06 21;11(6):e042302. Epub 2021 Jun 21.

Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil.

Introduction: Daily multidisciplinary rounds (DMRs) consist of systematic patient-centred discussions aiming to establish joint therapeutic goals for the next 24 hours of intensive care unit (ICU) care. The aim of the present study protocol is to evaluate whether an intervention consisting of guided DMRs, supported by a remote specialist and audit/feedback on care performance will reduce ICU length of stay compared with a control group.

Methods And Analysis: A multicentre, controlled, cluster-randomised superiority trial including 30 ICUs in Brazil (15 intervention and 15 control), from August 2019 to June 2021. In a parallel assignment, ICUs are randomised to a complex-intervention composed by daily rounds carried out through Tele-ICU by a remote ICU physician; development of local quality indicators dashboards coupled with monthly meetings with local leadership; and dissemination of evidence-based clinical protocols versus usual care. Primary outcome is ICU length of stay. Secondary outcomes include classification of the unit according to the profiles defined by the standardised resource use and the standardised mortality rate, hospital mortality, incidence of healthcare-associated infections, ventilator-free days at 28 days, patient-days receiving oral or enteral feeding, patient-days under light sedation or alert and calm, rate of patients under normoxaemia. All adult patients admitted after the beginning of the study in each participant ICU will be enrolled. Inclusion criteria (clusters): public Brazilian ICUs with a minimum of 8 ICU beds interested/committed to participating in the study. Exclusion criteria (clusters): units with fully established DMRs by an intensivist, specialised or step-down units.

Ethics And Dissemination: The study protocol was approved by the institutional review board (IRB) of the coordinator centre, and by IRBs of each enrolled hospital/ICU. Statistical analysis protocol is being prepared for submission before the end of patient's enrolment. Results will be disseminated through conferences, peer-reviewed journals and to each participating unit.

Trial Registration Number: NCT03920501; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2020-042302DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8217943PMC
June 2021

Quality of life and long-term outcomes after hospitalization for COVID-19: Protocol for a prospective cohort study (Coalition VII).

Rev Bras Ter Intensiva 2021 Jan-Mar;33(1):31-37

Hospital Moinhos de Vento - Porto Alegre (RS), Brasil.

Introduction: The long-term effects caused by COVID-19 are unknown. The present study aims to assess factors associated with health-related quality of life and long-term outcomes among survivors of hospitalization for COVID-19 in Brazil.

Methods: This is a multicenter prospective cohort study nested in five randomized clinical trials designed to assess the effects of specific COVID-19 treatments in over 50 centers in Brazil. Adult survivors of hospitalization due to proven or suspected SARS-CoV-2 infection will be followed-up for a period of 1 year by means of structured telephone interviews. The primary outcome is the 1-year utility score of health-related quality of life assessed by the EuroQol-5D3L. Secondary outcomes include all-cause mortality, major cardiovascular events, rehospitalizations, return to work or study, physical functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living, dyspnea assessed by the modified Medical Research Council dyspnea scale, need for long-term ventilatory support, symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale, symptoms of posttraumatic stress disorder assessed by the Impact of Event Scale-Revised, and self-rated health assessed by the EuroQol-5D3L Visual Analog Scale. Generalized estimated equations will be performed to test the association between five sets of variables (1- demographic characteristics, 2- premorbid state of health, 3- characteristics of acute illness, 4- specific COVID-19 treatments received, and 5- time-updated postdischarge variables) and outcomes.

Ethics And Dissemination: The study protocol was approved by the Research Ethics Committee of all participant institutions. The results will be disseminated through conferences and peer-reviewed journals.
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http://dx.doi.org/10.5935/0103-507X.20210003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8075344PMC
April 2021

Brazilian guidelines for the management of brain-dead potential organ donors. The task force of the Associação de Medicina Intensiva Brasileira, Associação Brasileira de Transplantes de Órgãos, Brazilian Research in Critical Care Network, and the General Coordination of the National Transplant System.

Rev Bras Ter Intensiva 2021 Jan-Mar;33(1):1-11

Hospital Moinhos de Vento - Porto Alegre (RS), Brasil.

Objective: To contribute to updating the recommendations for brain-dead potential organ donor management.

Methods: A group of 27 experts, including intensivists, transplant coordinators, transplant surgeons, and epidemiologists, answered questions related to the following topics were divided into mechanical ventilation, hemodynamics, endocrine-metabolic management, infection, body temperature, blood transfusion, and checklists use. The outcomes considered were cardiac arrests, number of organs removed or transplanted as well as function / survival of transplanted organs. The quality of evidence of the recommendations was assessed using the Grading of Recommendations Assessment, Development, and Evaluation system to classify the recommendations.

Results: A total of 19 recommendations were drawn from the expert panel. Of these, 7 were classified as strong, 11 as weak and 1 was considered a good clinical practice.

Conclusion: Despite the agreement among panel members on most recommendations, the grade of recommendation was mostly weak.
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http://dx.doi.org/10.5935/0103-507X.20210001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8075340PMC
December 2020

Brazilian guidelines for the management of brain-dead potential organ donors. The task force of the AMIB, ABTO, BRICNet, and the General Coordination of the National Transplant System.

Ann Intensive Care 2020 Dec 14;10(1):169. Epub 2020 Dec 14.

Hospital Moinhos de Vento (HMV), R. Ramiro Barcelos, 910, Porto Alegre, RS, 90035000, Brazil.

Objective: To contribute to updating the recommendations for brain-dead potential organ donor management.

Method: A group of 27 experts, including intensivists, transplant coordinators, transplant surgeons, and epidemiologists, joined a task force formed by the General Coordination Office of the National Transplant System/Brazilian Ministry of Health (CGSNT-MS), the Brazilian Association of Intensive Care Medicine (AMIB), the Brazilian Association of Organ Transplantation (ABTO), and the Brazilian Research in Intensive Care Network (BRICNet). The questions were developed within the scope of the 2011 Brazilian Guidelines for Management of Adult Potential Multiple-Organ Deceased Donors. The topics were divided into mechanical ventilation, hemodynamic support, endocrine-metabolic management, infection, body temperature, blood transfusion, and use of checklists. The outcomes considered for decision-making were cardiac arrest, number of organs recovered or transplanted per donor, and graft function/survival. Rapid systematic reviews were conducted, and the quality of evidence of the recommendations was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Two expert panels were held in November 2016 and February 2017 to classify the recommendations. A systematic review update was performed in June 2020, and the recommendations were reviewed through a Delphi process with the panelists between June and July 2020.

Results: A total of 19 recommendations were drawn from the expert panel. Of these, 7 were classified as strong (lung-protective ventilation strategy, vasopressors and combining arginine vasopressin to control blood pressure, antidiuretic hormones to control polyuria, serum potassium and magnesium control, and antibiotic use), 11 as weak (alveolar recruitment maneuvers, low-dose dopamine, low-dose corticosteroids, thyroid hormones, glycemic and serum sodium control, nutritional support, body temperature control or hypothermia, red blood cell transfusion, and goal-directed protocols), and 1 was considered a good clinical practice (volemic expansion).

Conclusion: Despite the agreement among panel members on most recommendations, the grade of recommendation was mostly weak. The observed lack of robust evidence on the topic highlights the importance of the present guideline to improve the management of brain-dead potential organ donors.
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http://dx.doi.org/10.1186/s13613-020-00787-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7736434PMC
December 2020

Statistical analysis plan for the Balanced Solution versus Saline in Intensive Care Study (BaSICS).

Rev Bras Ter Intensiva 2020 Oct-Dec;32(4):493-505

Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.

Objective: To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS).

Methods: BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will be blinded for investigators, patients and the analyses. No blinding will be possible for the infusion speed for the investigators, but all analyses will be kept blinded during the analysis procedure.

Results: BaSICS will have 90-day mortality as its primary endpoint, which will be tested using mixed-effects Cox proportional hazard models, considering sites as a random variable (frailty models) adjusted for age, organ dysfunction and admission type. Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days.

Conclusion: This manuscript provides details on the first version of the statistical analysis plan for the BaSICS trial and will guide the study's analysis when follow-up is finished.
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http://dx.doi.org/10.5935/0103-507X.20200081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7853670PMC
March 2020

Challenges for the development of alternative low-cost ventilators during COVID-19 pandemic in Brazil.

Rev Bras Ter Intensiva 2020 Jul-Sep;32(3):444-457

Serviço de Terapia Intensiva, Hospital do Servidor Público Estadual "Francisco Morato de Oliveira" - São Paulo (SP), Brasil.

The COVID-19 pandemic has brought concerns to managers, healthcare professionals, and the general population related to the potential mechanical ventilators' shortage for severely ill patients. In Brazil, there are several initiatives aimed at producing alternative ventilators to cover this gap. To assist the teams that work in these initiatives, we provide a discussion of some basic concepts on physiology and respiratory mechanics, commonly used mechanical ventilation terms, the differences between triggering and cycling, the basic ventilation modes and other relevant aspects, such as mechanisms of ventilator-induced lung injury, respiratory drive, airway heating and humidification, cross-contamination risks, and aerosol dissemination. After the prototype development phase, preclinical bench-tests and animal model trials are needed to determine the safety and performance of the ventilator, following the minimum technical requirements. Next, it is mandatory going through the regulatory procedures as required by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA). The manufacturing company should be appropriately registered by ANVISA, which also must be notified about the conduction of clinical trials, following the research protocol approval by the Research Ethics Committee. The registration requisition of the ventilator with ANVISA should include a dossier containing the information described in this paper, which is not intended to cover all related matters but to provide guidance on the required procedures.
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http://dx.doi.org/10.5935/0103-507X.20200075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7595729PMC
October 2020

COVID-19-associated ARDS treated with DEXamethasone (CoDEX): study design and rationale for a randomized trial.

Rev Bras Ter Intensiva 2020 Jul-Sep;32(3):354-362

Hospital Sírio-Libanês - São Paulo (SP), Brasil.

Objective: The infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV-2 infection (coronavirus disease 2019 - COVID-19) is viral pneumonia with varying degrees of respiratory compromise and up to 40% of hospitalized patients might develop acute respiratory distress syndrome. Several clinical trials evaluated the role of corticosteroids in non-COVID-19 acute respiratory distress syndrome with conflicting results. We designed a trial to evaluate the effectiveness of early intravenous dexamethasone administration on the number of days alive and free of mechanical ventilation within 28 days after randomization in adult patients with moderate or severe acute respiratory distress syndrome due to confirmed or probable COVID-19.

Methods: This is a pragmatic, prospective, randomized, stratified, multicenter, open-label, controlled trial including 350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, defined by the Berlin criteria, due to COVID-19. Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group). Patients in the intervention group will receive dexamethasone 20mg intravenous once daily for 5 days, followed by dexamethasone 10mg IV once daily for additional 5 days or until intensive care unit discharge, whichever occurs first. The primary outcome is ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation. Secondary outcomes are all-cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment Score evaluation at 48 hours, 72 hours and 7 days and intensive care unit -free days within 28.
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http://dx.doi.org/10.5935/0103-507X.20200063DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7595716PMC
October 2020

Rationale and design of the "Tocilizumab in patients with moderate to severe COVID-19: an open-label multicentre randomized controlled" trial (TOCIBRAS).

Rev Bras Ter Intensiva 2020 Jul-Sep;32(3):337-347

BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brasil.

Introduction: Pro-inflammatory markers play a significant role in the disease severity of patients with COVID-19. Thus, anti-inflammatory therapies are attractive agents for potentially combating the uncontrolled inflammatory cascade in these patients. We designed a trial testing tocilizumab versus standard of care intending to improve the outcomes by inhibiting interleukin-6, an important inflammatory mediator in COVID-19.

Methods And Analysis: This open-label multicentre randomized controlled trial will compare clinical outcomes of tocilizumab plus standard of care versus standard of care alone in patients with moderate to severe COVID-19. Two of the following four criteria are required for protocol enrolment: D-dimer > 1,000ng/mL; C reactive protein > 5mg/dL, ferritin > 300mg/dL, and lactate dehydrogenase > upper limit of normal. The primary objective will be to compare the clinical status on day 15, as measured by a 7-point ordinal scale applied in COVID-19 trials worldwide. The primary endpoint will be assessed by an ordinal logistic regression assuming proportional odds ratios adjusted for stratification variables (age and sex).

Ethics And Dissemination: The TOCIBRAS protocol was approved by local and central (national) ethical committees in Brazil following current national and international guidelines/directives. Each participating center had the study protocol approved by their institutional review boards before initiating protocol enrolment. The data derived from this trial will be published regardless of the results. If proven active, this strategy could alleviate the consequences of the inflammatory response in COVID-19 patients and improve their clinical outcomes.
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http://dx.doi.org/10.5935/0103-507X.20200060DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7595725PMC
October 2020

An international comparison of the cost of fluid resuscitation therapies.

Aust Crit Care 2021 01 20;34(1):23-32. Epub 2020 Aug 20.

Critical Care Division, The George Institute for Global Health, Sydney, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia. Electronic address:

Objective: Fluid resuscitation is a ubiquitous intervention in the management of patients treated in the intensive care unit, which has implications for intensive care unit resourcing and budgets. Our objective was to calculate the relative cost of resuscitation fluids in several countries to inform future economic evaluations.

Methods: We collected site-level data regarding the availability and cost of fluids as part of an international survey. We normalised costs to net present values using purchasing power parities and published inflation figures. Costs were also adjusted for equi-effective dosing based on intravascular volume expansion effectiveness and expressed as US dollars (USD) per 100 mL crystalloid equivalent.

Results: A total of 187 sites had access to cost data. Between countries, there was an approximate six fold variation in the cost of crystalloids and colloids overall. The average cost for crystalloids overall was less than 1 USD per 100 mL. In contrast, colloid fluids had higher average costs (59 USD per 100 mL). After adjusting for equi-effective dosing, saline was ∼27 times less costly than albumin (saline: 0.6 USD per 100 mL crystalloid equivalent; albumin 4-5%: 16.4 USD; albumin 20-25%: 15.8 USD) and ∼4 times less costly than hydroxyethyl starch solution (saline: 0.6 USD; hydroxyethyl starch solution: 2.5 USD). Buffered salt solutions, such as compound sodium acetate solutions (e.g., Plasmalyte®), had the highest average cost of crystalloid fluids, costing between 3 and 4 USD per 100 mL.

Conclusion: The cost of fluid varies substantially between fluid types and between countries, although normal (0.9%) saline is consistently less costly than colloid preparations and some buffered salt solutions. These data can be used to inform future economic evaluations of fluid preparations.
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http://dx.doi.org/10.1016/j.aucc.2020.06.001DOI Listing
January 2021

Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study).

Trials 2020 Jun 17;21(1):540. Epub 2020 Jun 17.

Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Porto Alegre, RS, 90035-001, Brazil.

Background: The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determine whether an evidence-based, goal-directed checklist for donor management in intensive care units (ICUs) can reduce donor losses to cardiac arrest.

Methods/design: The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care). The primary outcome is loss of potential donors due to cardiac arrest. Secondary outcomes are the number of actual organ donors and the number of solid organs recovered per actual donor. Exploratory outcomes include the achievement of relevant clinical goals during the management of brain-dead potential organ donors. The present statistical analysis plan (SAP) describes all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of the trial.

Discussion: The SAP of the DONORS study aims to describe its analytic procedures, enhancing the transparency of the study. At the moment of SAP subsmission, 63 institutions have been randomised and were enrolling study participants. Thus, the analyses reported herein have been defined before the end of the study recruitment and database locking.

Trial Registration: ClinicalTrials.gov, NCT03179020. Registered on 7 June 2017.
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http://dx.doi.org/10.1186/s13063-020-04457-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7298918PMC
June 2020

Organizational factors associated with adherence to low tidal volume ventilation: a secondary analysis of the CHECKLIST-ICU database.

Ann Intensive Care 2020 Jun 1;10(1):68. Epub 2020 Jun 1.

Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Albert Einstein Avenue, 700, São Paulo, Brazil.

Background: Survival benefit from low tidal volume (V) ventilation (LTVV) has been demonstrated for patients with acute respiratory distress syndrome (ARDS), and patients not having ARDS could also benefit from this strategy. Organizational factors may play a role on adherence to LTVV. The present study aimed to identify organizational factors with an independent association with adherence to LTVV.

Methods: Secondary analysis of the database of a multicenter two-phase study (prospective cohort followed by a cluster-randomized trial) performed in 118 Brazilian intensive care units. Patients under mechanical ventilation at day 2 were included. LTVV was defined as a V ≤ 8 ml/kg PBW on the second day of ventilation. Data on the type and number of beds of the hospital, teaching status, nursing, respiratory therapists and physician staffing, use of structured checklist, and presence of protocols were tested. A multivariable mixed-effect model was used to assess the association between organizational factors and adherence to LTVV.

Results: The study included 5719 patients; 3340 (58%) patients received LTVV. A greater number of hospital beds (absolute difference 7.43% [95% confidence interval 0.61-14.24%]; p = 0.038), use of structured checklist during multidisciplinary rounds (5.10% [0.55-9.81%]; p = 0.030), and presence of at least one nurse per 10 patients during all shifts (17.24% [0.85-33.60%]; p = 0.045) were the only three factors that had an independent association with adherence to LTVV.

Conclusions: Number of hospital beds, use of a structured checklist during multidisciplinary rounds, and nurse staffing are organizational factors associated with adherence to LTVV. These findings shed light on organizational factors that may improve ventilation in critically ill patients.
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http://dx.doi.org/10.1186/s13613-020-00687-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7266115PMC
June 2020

Valve Heart Surgery in Brazil - The BYPASS Registry Analysis.

Braz J Cardiovasc Surg 2020 02 1;35(1):82-90. Epub 2020 Feb 1.

Universidade Federal de São Paulo Escola Paulista de Medicina Hospital São Paulo São Paulo SP Brazil Discipline of Cardiovascular Surgery, Hospital São Paulo, Escola Paulista de Medicina, Universidade Federal de São Paulo - EPM-UNIFESP, São Paulo, SP, Brazil.

Objective: To analyze the profile and outcomes of patients who underwent valve heart surgery in Brazil, using information retrieved from the Brazilian Registry of Cardiovascular Surgeries in Adults (BYPASS Registry) database.

Methods: This is a multicenter cohort study, evaluating 920 patients submitted to heart valve surgery. Demographics and postoperative clinical outcomes were assessed and compared to estimate mortality risk using the European System for Cardiac Operative Risk Evaluation (EuroSCORE).

Results: Isolated aortic valve replacement was the most frequently performed surgery (34%), followed by isolated mitral valve replacement (24.9%). Valve repair was performed in 21% of mitral procedures. Minimally invasive access was performed in 1.6% and the most frequent postoperative complications were arrhythmias (22.6%), infections (5.7%), and low-output syndrome (5.1%). Operations covered by the public health system accounted for 80.8% and the hospital mortality rate was 7.3%.

Conclusion: The most frequent isolated valve surgery in Brazil is the aortic valve replacement by conventional open access and the rheumatic disease is still the main etiology for valve surgery. The BYPASS Registry has a fundamental role to provide information on the profile of patients with valve heart disease in our country in order to delineate adequate strategies for health promotion and resource allocation for cardiac surgery.
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http://dx.doi.org/10.21470/1678-9741-2019-0408DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7089740PMC
February 2020

Driving Pressure-limited Strategy for Patients with Acute Respiratory Distress Syndrome. A Pilot Randomized Clinical Trial.

Ann Am Thorac Soc 2020 05;17(5):596-604

HCor Research Institute, São Paulo, Brazil.

Evidence from observational studies suggests that driving pressure is strongly associated with pulmonary injury and mortality, regardless of positive end-expiratory pressure (PEEP) levels, tidal volume, or plateau pressure. Therefore, it is possible that targeting driving pressure may improve the safety of ventilation strategies for patients with acute respiratory distress syndrome (ARDS). However, the clinical effects of a driving pressure-limited strategy for ARDS has not been assessed in randomized controlled trials. To evaluate the feasibility of testing a driving pressure-limited strategy in comparison with a conventional lung-protective ventilation strategy in patients with ARDS and a baseline driving pressure of ≥13 cm HO. This was a randomized, controlled, nonblinded trial that included 31 patients with ARDS who were on invasive mechanical ventilation and had a driving pressure of ≥13 cm HO. Patients allocated to the driving pressure-limited strategy were ventilated with volume-controlled or pressure-support ventilation modes, with tidal volume titrated to 4-8 ml/kg of predicted body weight (PBW), aiming at a driving pressure of 10 cm HO, or the lowest possible. Patients in the control group were ventilated according to the ARDSNet (Acute Respiratory Distress Syndrome Network) protocol, using a tidal volume of 6 ml/kg PBW, which was allowed to be set down to 4 ml/kg PBW if the plateau pressure was >30 cm HO. The primary endpoint was the driving pressure on Days 1-3. Sixteen patients were randomized to the driving pressure-limited group and 15 were randomized to the conventional strategy group. All patients were considered in analyses. Most of the patients had mild ARDS with a mean arterial oxygen tension/fraction of inspired oxygen ratio of 215 (standard deviation [SD] = 95). The baseline driving pressure was 15.0 cm HO (SD = 2.6) in both groups. In comparison with the conventional strategy, driving pressure from the first hour to the third day was 4.6 cm HO lower in the driving pressure-limited group (95% confidence interval [CI], 6.5 to 2.8;  < 0.001). From the first hour up to the third day, tidal volume in the driving pressure-limited strategy group was kept lower than in the control group (mean difference [ml/kg of PBW], 1.3; 95% CI, 1.7 to 0.9;  < 0.001). We did not find statistically significant differences in the incidence of severe acidosis (pH < 7.10) within 7 days (absolute difference -12.1; 95% CI, -41.5 to -17.3) or any clinical secondary endpoint. In patients with ARDS, a trial assessing the effects of a driving pressure-limited strategy using very low tidal volumes versus a conventional ventilation strategy on clinical outcomes is feasible.Clinical trial registered with ClinicalTrials.gov (NCT02365038).
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http://dx.doi.org/10.1513/AnnalsATS.201907-506OCDOI Listing
May 2020

Effects of very early start of norepinephrine in patients with septic shock: a propensity score-based analysis.

Crit Care 2020 02 14;24(1):52. Epub 2020 Feb 14.

Departamento de Medicina Intensiva, Pontificia Universidad Católica de Chile, Santiago, Chile.

Background: Optimal timing for the start of vasopressors (VP) in septic shock has not been widely studied since it is assumed that fluids must be administered in advance. We sought to evaluate whether a very early start of VP, even without completing the initial fluid loading, might impact clinical outcomes in septic shock.

Methods: A total of 337 patients with sepsis requiring VP support for at least 6 h were initially selected from a prospectively collected database in a 90-bed mixed-ICU during a 24-month period. They were classified into very-early (VE-VPs) or delayed vasopressor start (D-VPs) categories according to whether norepinephrine was initiated or not within/before the next hour of the first resuscitative fluid load. Then, VE-VPs (n = 93) patients were 1:1 propensity matched to D-VPs (n = 93) based on age; source of admission (emergency room, general wards, intensive care unit); chronic and acute comorbidities; and lactate, heart rate, systolic, and diastolic pressure at vasopressor start. A risk-adjusted Cox proportional hazard model was fitted to assess the association between VE-VPs and day 28 mortality. Finally, a sensitivity analysis was performed also including those patients requiring VP support for less than 6 h.

Results: Patients subjected to VE-VPs received significantly less resuscitation fluids at vasopressor starting (0[0-510] vs. 1500[650-2300] mL, p < 0.001) and during the first 8 h of resuscitation (1100[500-1900] vs. 2600[1600-3800] mL, p < 0.001), with no significant increase in acute renal failure and/or renal replacement therapy requirements. VE-VPs was related with significant lower net fluid balances 8 and 24 h after VPs. VE-VPs was also associated with a significant reduction in the risk of death compared to D-VPs (HR 0.31, CI95% 0.17-0.57, p < 0.001) at day 28. Such association was maintained after including patients receiving vasopressors for < 6 h.

Conclusion: A very early start of vasopressor support seems to be safe, might limit the amount of fluids to resuscitate septic shock, and could lead to better clinical outcomes.
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http://dx.doi.org/10.1186/s13054-020-2756-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7023737PMC
February 2020

Machine learning to predict 30-day quality-adjusted survival in critically ill patients with cancer.

J Crit Care 2020 02 2;55:73-78. Epub 2019 Nov 2.

Department of Epidemiology, School of Public Health, University of São Paulo, São Paulo, Brazil.

Purpose: To develop and compare the predictive performance of machine-learning algorithms to estimate the risk of quality-adjusted life year (QALY) lower than or equal to 30 days (30-day QALY).

Material And Methods: Six machine-learning algorithms were applied to predict 30-day QALY for 777 patients admitted in a prospective cohort study conducted in Intensive Care Units (ICUs) of two public Brazilian hospitals specialized in cancer care. The predictors were 37 characteristics collected at ICU admission. Discrimination was evaluated using the area under the receiver operating characteristic (AUROC) curve. Sensitivity, 1-specificity, true/false positive and negative cases were measured for different estimated probability cutoff points (30%, 20% and 10%). Calibration was evaluated with GiViTI calibration belt and test.

Results: Except for basic decision trees, the adjusted predictive models were nearly equivalent, presenting good results for discrimination (AUROC curves over 0.80). Artificial neural networks and gradient boosted trees achieved the overall best calibration, implying an accurately predicted probability for 30-day QALY.

Conclusions: Except for basic decision trees, predictive models derived from different machine-learning algorithms discriminated the QALY risk at 30 days well. Regarding calibration, artificial neural network model presented the best ability to estimate 30-day QALY in critically ill oncologic patients admitted to ICUs.
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http://dx.doi.org/10.1016/j.jcrc.2019.10.015DOI Listing
February 2020

Inducing Brain Cooling Without Core Temperature Reduction in Pigs Using a Novel Nasopharyngeal Method: An Effectiveness and Safety Study.

Neurocrit Care 2020 04;32(2):564-574

Neurology Department, School of Medicine, University of São Paulo, Avenida Moema, 170, Cj. 83 - Moema, São Paulo, SP, CEP: 04077-020, Brazil.

Background: Acute brain lesions constitute an alarming public health concern. Neuroprotective therapies have been implemented to stabilize, prevent, or reduce brain lesions, thus improving neurological outcomes and survival rates. Hypothermia is the most effective approach, mainly attributed to the reduction in cellular metabolic activity. Whole-body cooling is currently implemented by healthcare professionals; however, adverse events are frequent, limiting the potential benefits of therapeutic hypothermia. Therefore, selective methods have been developed to reduce adverse events while delivering neuroprotection. Nasopharyngeal approaches are the safest and most effective methods currently considered. Our primary objective was to determine the effects of a novel nasopharyngeal catheter on the brain temperature of pigs.

Methods: In this prospective, non-randomized, interventional experimental trial, 10 crossbred pigs underwent nasopharyngeal cooling for 60 min followed by 15 min of rewarming. Nasopharyngeal catheters were inserted into the left nostril and properly positioned at the nasopharyngeal cavity.

Results: Nasopharyngeal cooling was associated with a decrease in brain temperature, which was more significant in the left cerebral hemisphere (p = 0.01). There was a reduction of 1.47 ± 0.86 °C in the first 5 min (p < 0.001), 2.45 ± 1.03 °C within 10 min (p < 0.001), and 4.45 ± 1.36 °C after 1 h (p < 0.001). The brain-core gradient was 4.57 ± 0.87 °C (p < 0.001). Rectal, esophageal, and pulmonary artery temperatures and brain and systemic hemodynamic parameters, remained stable during the procedure. Following brain cooling, values of oxygen partial pressure in brain tissue significantly decreased. No mucosal lesions were detected during nasal, pharyngeal, or oral inspection after nasopharyngeal catheter removal.

Conclusions: In this study, a novel nasopharyngeal cooling catheter effectively induced and maintained exclusive brain cooling when combined with effective counter-warming methods. Exclusive brain cooling was safe with no device-related local or systemic complications and may be desired in selected patient populations.
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http://dx.doi.org/10.1007/s12028-019-00789-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7223440PMC
April 2020

Effect of Flexible Family Visitation on Delirium Among Patients in the Intensive Care Unit: The ICU Visits Randomized Clinical Trial.

JAMA 2019 07;322(3):216-228

Intensive Care Unit, Hospital Regional Doutor Deoclécio Marques de Lucena, Parnamirim, Rio Grande do Norte, Brazil.

Importance: The effects of intensive care unit (ICU) visiting hours remain uncertain.

Objective: To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium.

Design, Setting And Participants: Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018.

Interventions: Flexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation.

Main Outcomes And Measures: Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory).

Results: Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, -1.7% [95% CI, -6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, -0.8% [95% CI, -2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, -3.8% [95% CI, -4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, -1.6 [95% CI, -2.3 to -0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, -1.2 [95% CI, -2.0 to -0.4]; P = .003) were significantly better with flexible visitation.

Conclusions And Relevance: Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium.

Trial Registration: ClinicalTrials.gov Identifier: NCT02932358.
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http://dx.doi.org/10.1001/jama.2019.8766DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6635909PMC
July 2019

Availability of resources to treat sepsis in Brazil: a random sample of Brazilian institutions.

Rev Bras Ter Intensiva 2019 May 30;31(2):193-201. Epub 2019 May 30.

Brazilian Research in Intensive Care Network - São Paulo (SP), Brasil.

Objective: To characterize resource availability from a nationally representative random sample of intensive care units in Brazil.

Methods: A structured online survey of participating units in the Sepsis PREvalence Assessment Database (SPREAD) study, a nationwide 1-day point prevalence survey to assess the burden of sepsis in Brazil, was sent to the medical director of each unit.

Results: A representative sample of 277 of the 317 invited units responded to the resources survey. Most of the hospitals had fewer than 500 beds (94.6%) with a median of 14 beds in the intensive care unit. Providing care for public-insured patients was the main source of income in two-thirds of the surveyed units. Own microbiology laboratory was not available for 26.8% of the surveyed intensive care units, and 10.5% did not always have access to blood cultures. Broad spectrum antibiotics were not always available in 10.5% of surveyed units, and 21.3% could not always measure lactate within three hours. Those institutions with a high resource availability (158 units, 57%) were usually larger and preferentially served patients from the private health system compared to institutions without high resource availability. Otherwise, those without high resource availability did not always have broad-spectrum antibiotics (24.4%), vasopressors (4.2%) or crystalloids (7.6%).

Conclusion: Our study indicates that a relevant number of units cannot perform basic monitoring and therapeutic interventions in septic patients. Our results highlight major opportunities for improvement to adhere to simple but effective interventions in Brazil.
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http://dx.doi.org/10.5935/0103-507X.20190033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6649213PMC
May 2019

New-onset atrial fibrillation in adult critically ill patients: a scoping review.

Intensive Care Med 2019 07 14;45(7):928-938. Epub 2019 May 14.

Department of Intensive Care, 4131, Copenhagen University Hospital, Rigshospitalet, 2100, Copenhagen, Denmark.

Purpose: New-onset atrial fibrillation (NOAF) is common and associated with increased morbidity and mortality. However, its clinical importance and management in critically ill patients are not well described. The aim of this scoping review is to assess the epidemiology and management strategies of NOAF during critical illness.

Method: The review was conducted in accordance with the PRISMA extension for scoping reviews. We searched PubMed, EMBASE and the Cochrane Library for studies assessing the incidence, outcome and management strategies of NOAF in adult critically ill patients. The quality of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.

Results: A total of 99 studies were included, of which 79 were observational and 20 were interventional. The incidence of NOAF varied from 1.7% to 43.9% with considerable inter-population variation (very low quality of evidence). Commonly identified risk factors for NOAF included higher age, cardiovascular comorbidities and sepsis. The occurrence of NOAF was associated with adverse outcomes, including stroke, prolonged length of stay and mortality (very low quality of evidence). We found limited data on the optimal management strategy with no evidence for firm benefit or harm for any intervention (very low/low quality of evidence).

Conclusions: The definition and incidence of NOAF in critically ill patients varied considerably and many risk factors were identified. NOAF seemed to be associated with adverse outcomes, but data were very limited and current management strategies are not evidence-based.
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http://dx.doi.org/10.1007/s00134-019-05633-xDOI Listing
July 2019

Effect of a Quality Improvement Intervention on Adherence to Therapies for Patients With Acute Ischemic Stroke and Transient Ischemic Attack: A Cluster Randomized Clinical Trial.

JAMA Neurol 2019 Aug;76(8):932-941

Research Institute, Hospital do Coração, São Paulo, Brazil.

Importance: Translating evidence into clinical practice in the management of acute ischemic stroke (AIS) and transient ischemic attack (TIA) is challenging, especially in low- and middle-income countries.

Objective: To assess the effect of a multifaceted quality improvement intervention on adherence to evidence-based therapies for care of patients with AIS and TIA.

Design, Setting And Participants: This 2-arm cluster-randomized clinical trial assessed 45 hospitals and 2336 patients with AIS and TIA for eligibility before randomization. Eligible hospitals were able to provide care for patients with AIS and TIA in Brazil, Argentina, and Peru. Recruitment started September 12, 2016, and ended February 26, 2018; follow-up ended June 29, 2018. Data were analyzed using the intention-to-treat principle.

Interventions: The multifaceted quality improvement intervention included case management, reminders, a roadmap and checklist for the therapeutic plan, educational materials, and periodic audit and feedback reports to each intervention cluster.

Main Outcomes And Measures: The primary outcome was a composite adherence score for AIS and TIA performance measures. Secondary outcomes included an all-or-none composite end point of performance measures, the individual process measure components of the composite end points, and clinical outcomes at 90 days after admission (stroke recurrence, death, and disability measured by the modified Rankin scale).

Results: A total of 36 hospitals and 1624 patients underwent randomization. Nineteen hospitals were randomized to the quality improvement intervention and 17 to routine care. The overall mean (SD) age of patients enrolled in the study was 69.4 (13.5) years, and 913 (56.2%) were men. Overall mean (SD) composite adherence score for the 10 performance measures in the intervention group hospitals compared with control group hospitals was 85.3% (20.1%) vs 77.8% (18.4%) (mean difference, 4.2%; 95% CI, -3.8% to 12.2%). As a secondary end point, 402 of 817 patients (49.2%) at intervention hospitals received all the therapies that they were eligible for vs 203 of 807 (25.2%) in the control hospitals (odds ratio, 2.59; 95% CI, 1.22-5.53; P = .01).

Conclusions And Relevance: A multifaceted quality improvement intervention did not result in a significant increase in composite adherence score for evidence-based therapies in patients with AIS or TIA. However, when using an all-or-none approach, the intervention resulted in improved adherence to evidence-based therapies.

Trial Registration: ClinicalTrials.gov identifier: NCT02223273.
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http://dx.doi.org/10.1001/jamaneurol.2019.1012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6692700PMC
August 2019

Comparison of Biological and Mechanical Prostheses for Heart Valve Surgery: A Systematic Review of Randomized Controlled Trials.

Arq Bras Cardiol 2019 03 7;112(3):292-301. Epub 2019 Jan 7.

Hospital do Coração (HCOR), São Paulo, SP - Brazil.

Background: The choice of a mechanical (MP) or biological prosthesis (BP) for patients with valvular heart disease undergoing replacement is still not a consensus.

Objective: We aimed to determine the clinical outcomes of MP or BP placement in those patients.

Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) that compared biological prostheses and mechanical prostheses in patients with valvular heart diseases and assessed the outcomes. RCTs were searched in the MEDLINE, EMBASE, LILACS, CENTRAL, SCOPUS and Web of Science (from inception to November 2014) databases. Meta-analyses were performed using inverse variance with random effects models. The GRADE system was used to rate the quality of the evidence. A P-value lower than 0.05 was considered significant.

Results: A total of four RCTs were included in the meta-analyses (1,528 patients) with follow up ranging from 2 to 20 years. Three used old generation mechanical and biological prostheses, and one used contemporary prostheses. No significant difference in mortality was found between BP and MP patients (risk ratio (RR = 1.07; 95% CI 0.99-1.15). The risk of bleeding was significantly lower in BP patients than MP patients (RR = 0.64; 95% CI 0.52-0.78); however, reoperations were significantly more frequent in BP patients (RR = 3.60; 95% CI 2.44-5.32). There were no statistically significant differences between BP and MP patients with respect to systemic arterial embolisms and infective endocarditis (RR = 0.93; 95% CI 0.66-1.31, RR = 1.21; CI95% 0.78-1.88, respectively). Results in the trials with modern and old prostheses were similar.

Conclusions: The mortality rate and the risk of thromboembolic events and endocarditis were similar between BP and MP patients. The risk of bleeding was approximately one third lower for BP patients than for MP patients, while the risk of reoperations was more than three times higher for BP patients.
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http://dx.doi.org/10.5935/abc.20180272DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6424027PMC
March 2019

Coronary Artery Bypass Surgery in Brazil: Analysis of the National Reality Through the BYPASS Registry.

Braz J Cardiovasc Surg 2019 Mar-Apr;34(2):142-148

Instituto de Cirurgia Cardiovascular (ICCV)/Hospital Nossa Senhora da Salete, Cascavel, PR, Brazil.

Introduction: Coronary artery bypass grafting (CABG) is the most frequently performed heart surgery in Brazil. Recent international guidelines recommend that national societies establish a database on the practice and results of CABG. In anticipation of the recommendation, the BYPASS Registry was introduced in 2015.

Objective: To analyze the profile, risk factors and outcomes of patients undergoing CABG in Brazil, as well as to examine the predominant surgical strategy, based on the data included in the BYPASS Registry.

Methods: A cross-sectional study of 2292 patients undergoing CABG surgery and cataloged in the BYPASS Registry up to November 2018. Demographic data, clinical presentation, operative variables, and postoperative hospital outcomes were analyzed.

Results: Patients referred to CABG in Brazil are predominantly male (71%), with prior myocardial infarction in 41.1% of cases, diabetes in 42.5%, and ejection fraction lower than 40% in 9.7%. The Heart Team indicated surgery in 32.9% of the cases. Most of the patients underwent cardiopulmonary bypass (87%), and cardioplegia was the strategy of myocardial protection chosen in 95.2% of the cases. The left internal thoracic artery was used as a graft in 91% of the cases; the right internal thoracic artery, in 5.6%; and the radial artery in 1.1%. The saphenous vein graft was used in 84.1% of the patients, being the only graft employed in 7.7% of the patients. The median number of coronary vessels treated was 3. Operative mortality was 2.8%, and the incidence of cerebrovascular accident was 1.2%.

Conclusion: CABG data in Brazil provided by the BYPASS Registry analysis are representative of our national reality and practice. This database constitutes an important reference for indications and comparisons of therapeutic procedures, as well as to propose subsequent models to improve patient safety and the quality of surgical practice in the country.
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http://dx.doi.org/10.21470/1678-9741-2018-0313DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436784PMC
June 2019

The Elusive Search for "Best PEEP" and Whether Esophageal Pressure Monitoring Helps.

JAMA 2019 03;321(9):839-841

Department of Intensive Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil.

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http://dx.doi.org/10.1001/jama.2019.0267DOI Listing
March 2019

Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock: The ANDROMEDA-SHOCK Randomized Clinical Trial.

JAMA 2019 02;321(7):654-664

Departmento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago.

Importance: Abnormal peripheral perfusion after septic shock resuscitation has been associated with organ dysfunction and mortality. The potential role of the clinical assessment of peripheral perfusion as a target during resuscitation in early septic shock has not been established.

Objective: To determine if a peripheral perfusion-targeted resuscitation during early septic shock in adults is more effective than a lactate level-targeted resuscitation for reducing mortality.

Design, Setting, And Participants: Multicenter, randomized trial conducted at 28 intensive care units in 5 countries. Four-hundred twenty-four patients with septic shock were included between March 2017 and March 2018. The last date of follow-up was June 12, 2018.

Interventions: Patients were randomized to a step-by-step resuscitation protocol aimed at either normalizing capillary refill time (n = 212) or normalizing or decreasing lactate levels at rates greater than 20% per 2 hours (n = 212), during an 8-hour intervention period.

Main Outcomes And Measures: The primary outcome was all-cause mortality at 28 days. Secondary outcomes were organ dysfunction at 72 hours after randomization, as assessed by Sequential Organ Failure Assessment (SOFA) score (range, 0 [best] to 24 [worst]); death within 90 days; mechanical ventilation-, renal replacement therapy-, and vasopressor-free days within 28 days; intensive care unit and hospital length of stay.

Results: Among 424 patients randomized (mean age, 63 years; 226 [53%] women), 416 (98%) completed the trial. By day 28, 74 patients (34.9%) in the peripheral perfusion group and 92 patients (43.4%) in the lactate group had died (hazard ratio, 0.75 [95% CI, 0.55 to 1.02]; P = .06; risk difference, -8.5% [95% CI, -18.2% to 1.2%]). Peripheral perfusion-targeted resuscitation was associated with less organ dysfunction at 72 hours (mean SOFA score, 5.6 [SD, 4.3] vs 6.6 [SD, 4.7]; mean difference, -1.00 [95% CI, -1.97 to -0.02]; P = .045). There were no significant differences in the other 6 secondary outcomes. No protocol-related serious adverse reactions were confirmed.

Conclusions And Relevance: Among patients with septic shock, a resuscitation strategy targeting normalization of capillary refill time, compared with a strategy targeting serum lactate levels, did not reduce all-cause 28-day mortality.

Trial Registration: ClinicalTrials.gov Identifier: NCT03078712.
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http://dx.doi.org/10.1001/jama.2019.0071DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439620PMC
February 2019

Organizational factors associated with target sedation on the first 48 h of mechanical ventilation: an analysis of checklist-ICU database.

Crit Care 2019 Jan 29;23(1):34. Epub 2019 Jan 29.

Research Institute, HCor-Hospital do Coração, São Paulo, Brazil.

Background: Although light sedation levels are associated with several beneficial outcomes for critically ill patients on mechanical ventilation, the majority of patients are still deeply sedated. Organizational factors may play a role on adherence to light sedation levels. We aimed to identify organizational factors associated with a moderate to light sedation target on the first 48 h of mechanical ventilation, as well as the association between early achievement of within-target sedation and mortality.

Methods: This study is a secondary analysis of a multicenter two-phase study (prospective cohort followed by a cluster-randomized controlled trial) performed in 118 Brazilian ICUs. We included all critically ill patients who were on mechanical ventilation 48 h after ICU admission. A moderate to light level of sedation or being alert and calm (i.e., the Richmond Agitation-Sedation Scale of - 3 to 0) was the target for all patients on mechanical ventilation during the study period. We collected data on the type of hospital (public, private, profit and private, nonprofit), hospital teaching status, nursing and physician staffing, and presence of sedation, analgesia, and weaning protocols. We used multivariate random-effects regression with ICU and study phase as random-effects and correction for patients' Simplified Acute Physiology Score 3 and Sequential Organ Failure Assessment. We also performed a mediation analysis to explore whether sedation level was just a mediator of the association between organizational factors and mortality.

Results: We included 5719 patients. Only 1710 (29.9%) were on target sedation levels on day 2. Board-certified intensivists on the morning and afternoon shifts were associated with an adequate sedation level on day 2 (OR = 2.43; CI 95%, 1.09-5.38). Target sedation levels were associated with reduced hospital mortality (OR = 0.63; CI 95%, 0.55-0.72). Mediation analysis also suggested such an association, but did not suggest a relationship between the physician staffing model and hospital mortality.

Conclusions: Board-certified intensivists on morning and afternoon shifts were associated with an increased number of patients achieving lighter sedation goals. These findings reinforce the importance of organizational factors, such as intensivists' presence, as a modifiable quality improvement target.
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http://dx.doi.org/10.1186/s13054-019-2323-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6352335PMC
January 2019

Does the RYGB common limb length influence hypertension remission and cardiometabolic risk factors? Data from the GATEWAY trial.

Surg Obes Relat Dis 2019 Feb 27;15(2):211-217. Epub 2018 Nov 27.

Hypertension Unit, Heart Institute, Sao Paulo, Brazil.

Background: Although Roux-en-Y gastric bypass (RYGB) results in significant weight loss and cardiometabolic risk factors improvements; there is no consensus whether limb lengths may influence these results.

Objective: To evaluate the correlations between the common limb length (CLL) and hypertension remission rate, cardiometabolic risk factors, and nutritional parameters after RYGB.

Settings: Private Hospital, Brazil.

Methods: GATEWAY is a randomized trial designed to evaluate the efficacy of RYGB on hypertension improvement and other cardiometabolic risk factors in patients with grade I and II obesity compared with medical therapy. The follow-up was 1 year. We measured the entire bowel in all patients and used a 150-cm alimentary limb and a 100-cm biliopancreatic limb. Univariate logistic regression was used to estimate the relationship between CLL and hypertension remission. Pearson and Spearman correlation were used to evaluate the correlation between the CLL and the percentage changes of cardiometabolic risk factors and nutritional parameters.

Results: From 100 randomized patients, 45 were submitted to RYGB and completed the follow-up. Mean CLL was 466.3 ± 86.4 cm. Of patients, 55.6% from the RYGB group showed remission of hypertension. CLL length was not significantly associated with hypertension remission (odds ratio [95% confidence interval] for 50 units increase in CLL: .97 [.68; 1.38], P = .88). Consistently, we found no correlations between CLL and all changes in cardiometabolic risk factors and nutritional parameters.

Conclusions: In a proximal RYGB, CLL does not influence hypertension remission, cardiometabolic risk factors, and nutritional parameters.
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http://dx.doi.org/10.1016/j.soard.2018.11.022DOI Listing
February 2019
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