Publications by authors named "Giuseppe Citerio"

219 Publications

Association of Dose of Intracranial Hypertension with Outcome in Subarachnoid Hemorrhage.

Neurocrit Care 2021 Apr 12. Epub 2021 Apr 12.

Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.

Background: In patients with aneurysmal subarachnoid hemorrhage (aSAH) the burden of intracranial pressure (ICP) and its contribution to outcomes remains unclear. In this multicenter study, the independent association between intensity and duration, or "dose," of episodes of intracranial hypertension and 12-month neurological outcomes was investigated.

Methods: This was a retrospective analysis of multicenter prospectively collected data of 98 adult patients with aSAH amendable to treatment. Patients were admitted to the intensive care unit of two European centers (Medical University of Innsbruck [Austria] and San Gerardo University Hospital of Monza [Italy]) from 2009 to 2013. The dose of intracranial hypertension was visualized. The obtained visualizations allowed us to investigate the association between intensity and duration of episodes of intracranial hypertension and the 12-month neurological outcomes of the patients, assessed with the Glasgow Outcome Score. The independent association between the cumulative dose of intracranial hypertension and outcome for each patient was investigated by using multivariable logistic regression models corrected for age, occurrence of delayed cerebral ischemia, and the Glasgow Coma Scale score at admission.

Results: The combination of duration and intensity defined the tolerance to intracranial hypertension for the two cohorts of patients. A semiexponential transition divided ICP doses that were associated with better outcomes (in blue) with ICP doses associated with worse outcomes (in red). In addition, in both cohorts, an independent association was found between the cumulative time that the patient experienced ICP doses in the red area and long-term neurological outcomes. The ICP pressure-time burden was a stronger predictor of outcomes than the cumulative time spent by the patients with an ICP greater than 20 mmHg.

Conclusions: In two cohorts of patients with aSAH, an association between duration and intensity of episodes of elevated ICP and 12-month neurological outcomes could be demonstrated and was visualized in a color-coded plot.
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http://dx.doi.org/10.1007/s12028-021-01221-4DOI Listing
April 2021

Helmet CPAP to treat hypoxic pneumonia outside the ICU: an observational study during the COVID-19 outbreak.

Crit Care 2021 02 24;25(1):80. Epub 2021 Feb 24.

ASST Monza, San Gerardo Hospital, Monza, Italy.

Background: Respiratory failure due to COVID-19 pneumonia is associated with high mortality and may overwhelm health care systems, due to the surge of patients requiring advanced respiratory support. Shortage of intensive care unit (ICU) beds required many patients to be treated outside the ICU despite severe gas exchange impairment. Helmet is an effective interface to provide continuous positive airway pressure (CPAP) noninvasively. We report data about the usefulness of helmet CPAP during pandemic, either as treatment, a bridge to intubation or a rescue therapy for patients with care limitations (DNI).

Methods: In this observational study we collected data regarding patients failing standard oxygen therapy (i.e., non-rebreathing mask) due to COVID-19 pneumonia treated with a free flow helmet CPAP system. Patients' data were recorded before, at initiation of CPAP treatment and once a day, thereafter. CPAP failure was defined as a composite outcome of intubation or death.

Results: A total of 306 patients were included; 42% were deemed as DNI. Helmet CPAP treatment was successful in 69% of the full treatment and 28% of the DNI patients (P < 0.001). With helmet CPAP, PaO/FiO ratio doubled from about 100 to 200 mmHg (P < 0.001); respiratory rate decreased from 28 [22-32] to 24 [20-29] breaths per minute, P < 0.001). C-reactive protein, time to oxygen mask failure, age, PaO/FiO during CPAP, number of comorbidities were independently associated with CPAP failure. Helmet CPAP was maintained for 6 [3-9] days, almost continuously during the first two days. None of the full treatment patients died before intubation in the wards.

Conclusions: Helmet CPAP treatment is feasible for several days outside the ICU, despite persistent impairment in gas exchange. It was used, without escalating to intubation, in the majority of full treatment patients after standard oxygen therapy failed. DNI patients could benefit from helmet CPAP as rescue therapy to improve survival.

Trial Registration: NCT04424992.
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http://dx.doi.org/10.1186/s13054-021-03502-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903369PMC
February 2021

Use and impact of high intensity treatments in patients with traumatic brain injury across Europe: a CENTER-TBI analysis.

Crit Care 2021 02 23;25(1):78. Epub 2021 Feb 23.

Division of Anaesthesia, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK.

Purpose: To study variation in, and clinical impact of high Therapy Intensity Level (TIL) treatments for elevated intracranial pressure (ICP) in patients with traumatic brain injury (TBI) across European Intensive Care Units (ICUs).

Methods: We studied high TIL treatments (metabolic suppression, hypothermia (< 35 °C), intensive hyperventilation (PaCO < 4 kPa), and secondary decompressive craniectomy) in patients receiving ICP monitoring in the ICU stratum of the CENTER-TBI study. A random effect logistic regression model was used to determine between-centre variation in their use. A propensity score-matched model was used to study the impact on outcome (6-months Glasgow Outcome Score-extended (GOSE)), whilst adjusting for case-mix severity, signs of brain herniation on imaging, and ICP.

Results: 313 of 758 patients from 52 European centres (41%) received at least one high TIL treatment with significant variation between centres (median odds ratio = 2.26). Patients often transiently received high TIL therapies without escalation from lower tier treatments. 38% of patients with high TIL treatment had favourable outcomes (GOSE ≥ 5). The use of high TIL treatment was not significantly associated with worse outcome (285 matched pairs, OR 1.4, 95% CI [1.0-2.0]). However, a sensitivity analysis excluding high TIL treatments at day 1 or use of metabolic suppression at any day did reveal a statistically significant association with worse outcome.

Conclusion: Substantial between-centre variation in use of high TIL treatments for TBI was found and treatment escalation to higher TIL treatments were often not preceded by more conventional lower TIL treatments. The significant association between high TIL treatments after day 1 and worse outcomes may reflect aggressive use or unmeasured confounders or inappropriate escalation strategies.

Take Home Message: Substantial variation was found in the use of highly intensive ICP-lowering treatments across European ICUs and a stepwise escalation strategy from lower to higher intensity level therapy is often lacking. Further research is necessary to study the impact of high therapy intensity treatments.

Trial Registration: The core study was registered with ClinicalTrials.gov, number NCT02210221, registered 08/06/2014, https://clinicaltrials.gov/ct2/show/NCT02210221?id=NCT02210221&draw=1&rank=1 and with Resource Identification Portal (RRID: SCR_015582).
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http://dx.doi.org/10.1186/s13054-020-03370-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7901510PMC
February 2021

How the COVID-19 pandemic will change the future of critical care.

Intensive Care Med 2021 Mar 22;47(3):282-291. Epub 2021 Feb 22.

School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.

Coronavirus disease 19 (COVID-19) has posed unprecedented healthcare system challenges, some of which will lead to transformative change. It is obvious to healthcare workers and policymakers alike that an effective critical care surge response must be nested within the overall care delivery model. The COVID-19 pandemic has highlighted key elements of emergency preparedness. These include having national or regional strategic reserves of personal protective equipment, intensive care unit (ICU) devices, consumables and pharmaceuticals, as well as effective supply chains and efficient utilization protocols. ICUs must also be prepared to accommodate surges of patients and ICU staffing models should allow for fluctuations in demand. Pre-existing ICU triage and end-of-life care principles should be established, implemented and updated. Daily workflow processes should be restructured to include remote connection with multidisciplinary healthcare workers and frequent communication with relatives. The pandemic has also demonstrated the benefits of digital transformation and the value of remote monitoring technologies, such as wireless monitoring. Finally, the pandemic has highlighted the value of pre-existing epidemiological registries and agile randomized controlled platform trials in generating fast, reliable data. The COVID-19 pandemic is a reminder that besides our duty to care, we are committed to improve. By meeting these challenges today, we will be able to provide better care to future patients.
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http://dx.doi.org/10.1007/s00134-021-06352-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7898492PMC
March 2021

Intensive Care Admission and Management of Patients With Acute Ischemic Stroke: A Cross-sectional Survey of the European Society of Intensive Care Medicine.

J Neurosurg Anesthesiol 2021 Feb 9. Epub 2021 Feb 9.

Department of Anaesthesia and Intensive Care, Policlinico San Martino IRCCS for Oncology and Neuroscience Department of Surgical Science and Diagnostic Integrated, University of Genoa, Genoa Neurointensive Care Unit, San Gerardo Hospital, ASST-Monza, Monza School of Medicine and Surgery, University of Milano-Bicocca, Milano, Italy Department of Intensive Care Medicine, University Hospitals Leuven, Leuven, Belgium Department of Intensive Care Adults, Erasmus MC-University Medical Center, Rotterdam, The Netherlands Department of Medical Physics and Biomedical Engineering, University College London Neurocritical Care Unit, The National Hospital for Neurology and Neurosurgery, University College London Hospitals, London, UK.

Background: No specific recommendations are available regarding the intensive care management of critically ill acute ischemic stroke (AIS) patients, and questions remain regarding optimal ventilatory, hemodynamic, and general intensive care unit (ICU) therapeutic targets in this population. We performed an international survey to investigate ICU admission criteria and management of AIS patients.

Methods: An electronic questionnaire including 25 items divided into 3 sections was available on the European Society of Intensive Care Medicine Web site between November 1, 2019 and March 30, 2020 and advertised through the neurointensive care (NIC) section newsletter. This survey was emailed directly to the NIC members and was endorsed by the European Society of Intensive Care Medicine.

Results: There were 214 respondents from 198 centers, with response rate of 16.5% of total membership (214/1296). In most centers (67%), the number of AIS patients admitted to respondents' hospitals in 2019 was between 100 and 300, and, among them, fewer than 50 required ICU admission per hospital. The most widely accepted indication for ICU admission criteria was a requirement for intubation and mechanical ventilation. A standard protocol for arterial blood pressure (ABP) management was utilized by 88 (58%) of the respondents. For patients eligible for intravenous thrombolysis, the most common ABP target was <185/110 mm Hg (n=77 [51%]), whereas for patients undergoing mechanical thrombectomy it was ≤160/90 mm Hg (n=79 [54%]). The preferred drug for reducing ABP was labetalol (n=84 [55.6%]). Other frequently used therapeutic targets included: blood glucose 140 to 180 mg/dL (n=65 [43%]) maintained with intravenous insulin infusion in most institutions (n=110 [72.4%]); enteral feeding initiated within 2 to 3 days from stroke onset (n=142 [93.4%]); oxygen saturation (SpO2) >95% (n=80 [53%]), and tidal volume 6 to 8 mL/kg of predicted body weight (n=135 [89%]).

Conclusions: The ICU management of AIS, including therapeutic targets and clinical practice strategies, importantly varies between centers. Our findings may be helpful to define future studies and create a research agenda regarding the ICU therapeutic targets for AIS patients.
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http://dx.doi.org/10.1097/ANA.0000000000000761DOI Listing
February 2021

Surviving Sepsis Campaign Guidelines on the Management of Adults With Coronavirus Disease 2019 (COVID-19) in the ICU: First Update.

Crit Care Med 2021 03;49(3):e219-e234

Adult Critical Care, St George's University Hospitals NHS Foundation Trust & St George's University of London, London, United Kingdom.

Background: The coronavirus disease 2019 pandemic continues to affect millions worldwide. Given the rapidly growing evidence base, we implemented a living guideline model to provide guidance on the management of patients with severe or critical coronavirus disease 2019 in the ICU.

Methods: The Surviving Sepsis Campaign Coronavirus Disease 2019 panel has expanded to include 43 experts from 14 countries; all panel members completed an electronic conflict-of-interest disclosure form. In this update, the panel addressed nine questions relevant to managing severe or critical coronavirus disease 2019 in the ICU. We used the World Health Organization's definition of severe and critical coronavirus disease 2019. The systematic reviews team searched the literature for relevant evidence, aiming to identify systematic reviews and clinical trials. When appropriate, we performed a random-effects meta-analysis to summarize treatment effects. We assessed the quality of the evidence using the Grading of Recommendations, Assessment, Development, and Evaluation approach, then used the evidence-to-decision framework to generate recommendations based on the balance between benefit and harm, resource and cost implications, equity, and feasibility.

Results: The Surviving Sepsis Campaign Coronavirus Diease 2019 panel issued nine statements (three new and six updated) related to ICU patients with severe or critical coronavirus disease 2019. For severe or critical coronavirus disease 2019, the panel strongly recommends using systemic corticosteroids and venous thromboprophylaxis but strongly recommends against using hydroxychloroquine. In addition, the panel suggests using dexamethasone (compared with other corticosteroids) and suggests against using convalescent plasma and therapeutic anticoagulation outside clinical trials. The Surviving Sepsis Campaign Coronavirus Diease 2019 panel suggests using remdesivir in nonventilated patients with severe coronavirus disease 2019 and suggests against starting remdesivir in patients with critical coronavirus disease 2019 outside clinical trials. Because of insufficient evidence, the panel did not issue a recommendation on the use of awake prone positioning.

Conclusion: The Surviving Sepsis Campaign Coronavirus Diease 2019 panel issued several recommendations to guide healthcare professionals caring for adults with critical or severe coronavirus disease 2019 in the ICU. Based on a living guideline model the recommendations will be updated as new evidence becomes available.
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http://dx.doi.org/10.1097/CCM.0000000000004899DOI Listing
March 2021

Overcoming the Limits of Reconditioning: Seventeen Hours of Ex-Vivo Lung Perfusion (EVLP) with Successful Transplantation from Uncontrolled Circulatory Death Donor.

Transplantation 2021 Jan 25. Epub 2021 Jan 25.

Thoracic Surgery and Lung Transplantation Unit, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico of Milan, Milan, Italy. University of Milan, Milan, Italy. Anesthesia, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico of Milan, Milan, Italy. Pathology Unit, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico of Milan, Milan, Italy. Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico of Milan, Milan, Italy. San Gerardo Hospital, ASST-Monza, Monza, Italy. University of Milano-Bicocca, Milan, Italy.

Background: Uncontrolled donors after circulatory death (DCD) are an extraordinary resource to increase the number of lungs available for transplantation. However, the risk of the warm ischemia resulting from cardiac arrest to irreversibly damage the organs is considerable. Moreover, graft preservation issues and organizational problems often worsen the dangerous effects of warm ischemia. Ex-Vivo Lung Perfusion (EVLP) enables to evaluate and recondition lungs whose functionality is doubtful, as well as to overcome the difficulties related to time and logistics.

Methods: We report the case of uncontrolled DCD lungs successfully treated with an exceptionally prolonged EVLP. Since the donor's blood count and liver biopsy showed signs of a possible leukaemia, EVLP was protracted up to seventeen hours while waiting for immunohistochemical analyses to rule out this diagnosis; eventually, the results came back negative and lungs were judged suitable for transplantation.

Results: The recipient was a 32-year old male with cystic fibrosis, colonized by Pandoraea pnomenusa. Bilateral transplantation required central extracorporeal membrane oxygenation. The patient was extubated after 36 hours and was discharged 21 days after the operation. Despite early re-colonization by Pandoraea pnomenusa and airway complications requiring pneumatic dilatation, he is alive and has a satisfactory respiratory function 15 months after transplantation.

Conclusions: Uncontrolled DCD represents a challenge due to both logistical issues and the complexity of grafts evaluation before procurement: EVLP with cellular perfusate could be a valuable tool to overcome these limits. Nonetheless, caution should be exercised when interpreting the effects of this technique on airway healing.
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http://dx.doi.org/10.1097/TP.0000000000003646DOI Listing
January 2021

Mortality and HRQoL in ICU patients with delirium: Protocol for 1-year follow-up of AID-ICU trial.

Acta Anaesthesiol Scand 2020 11 16;64(10):1519-1525. Epub 2020 Aug 16.

Department of Anaesthesiology and Intensive Care Medicine, Centre for Anaesthesiological Research, Zealand University Hospital, Koege, Denmark.

Background: Intensive care unit (ICU)-acquired delirium is frequent and associated with poor short- and long-term outcomes for patients in ICUs. It therefore constitutes a major healthcare problem. Despite limited evidence, haloperidol is the most frequently used pharmacological intervention against ICU-acquired delirium. Agents intervening against Delirium in the ICU (AID-ICU) is an international, multicentre, randomised, blinded, placebo-controlled trial investigates benefits and harms of treatment with haloperidol in patients with ICU-acquired delirium. The current pre-planned one-year follow-up study of the AID-ICU trial population aims to explore the effects of haloperidol on one-year mortality and health related quality of life (HRQoL).

Methods: The AID-ICU trial will include 1000 participants. One-year mortality will be obtained from the trial sites; we will validate the vital status of Danish participants using the Danish National Health Data Registers. Mortality will be analysed by Cox-regression and visualized by Kaplan-Meier curves tested for significance using the log-rank test. We will obtain HRQoL data using the EQ-5D instrument. HRQoL analysis will be performed using a general linear model adjusted for stratification variables. Deceased participants will be designated the worst possible value.

Results: We expect to publish results of this study in 2022.

Conclusion: We expect that this one-year follow-up study of participants with ICU-acquired delirium allocated to haloperidol vs. placebo will provide important information on the long-term consequences of delirium including the effects of haloperidol. We expect that our results will improve the care of this vulnerable patient group.
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http://dx.doi.org/10.1111/aas.13679DOI Listing
November 2020

Delirium in Patients with SARS-CoV-2 Infection: A Multicenter Study.

J Am Geriatr Soc 2021 02 8;69(2):293-299. Epub 2020 Dec 8.

School of Medicine and Surgery, University of Milano, Bicocca, Monza, Italy.

Objectives: The aims of this study are to report the prevalence of delirium on admission to the unit in patients hospitalized with SARS-CoV-2 infection, to identify the factors associated with delirium, and to evaluate the association between delirium and in-hospital mortality.

Design: Multicenter observational cohort study.

Settings: Acute medical units in four Italian hospitals.

Participants: A total of 516 patients (median age 78 years) admitted to the participating centers with SARS-CoV-2 infection from February 22 to May 17, 2020.

Measurements: Comprehensive medical assessment with detailed history, physical examinations, functional status, laboratory and imaging procedures. On admission, delirium was determined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition) criteria, 4AT, m-Richmond Agitation Sedation Scale, or clinical impression depending on the site. The primary outcomes were delirium rates and in-hospital mortality.

Results: Overall, 73 (14.1%, 95% confidence interval (CI) = 11.0-17.3%) patients presented delirium on admission. Factors significantly associated with delirium were dementia (odds ratio, OR = 4.66, 95% CI = 2.03-10.69), the number of chronic diseases (OR = 1.20, 95% CI = 1.03; 1.40), and chest X-ray or CT opacity (OR = 3.29, 95% CI = 1.12-9.64 and 3.35, 95% CI = 1.07-10.47, for multiple or bilateral opacities and single opacity vs no opacity, respectively). There were 148 (33.4%) in-hospital deaths in the no-delirium group and 43 (58.9%) in the delirium group (P-value assessed using the Gray test <.001). As assessed by a multivariable Cox model, patients with delirium on admission showed an almost twofold increased hazard ratio for in-hospital mortality with respect to patients without delirium (hazard ratio = 1.88, 95% CI = 1.25-2.83).

Conclusion: Delirium is prevalent and associated with in-hospital mortality among older patients hospitalized with SARS-CoV-2 infection.
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http://dx.doi.org/10.1111/jgs.16969DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753490PMC
February 2021

Noninvasive Ventilatory Support of COVID-19 Patients Outside the Intensive Care Units (WARd-COVID).

Ann Am Thorac Soc 2021 Jan 4. Epub 2021 Jan 4.

University of Milano-Bicocca, Milan, Italy , Department of Medicine and Surgery, Milano, Italy.

Rationale: Treatment with non-invasive ventilation (NIV) in COVID-19 is frequent. Shortage of Intensive care unit (ICU) beds led clinicians to deliver NIV also outside intensive care units (ICUs). Data about the use of NIV in COVID-19 is limited.

Objective: To describe the prevalence and clinical characteristics of patients with COVID-19 treated with NIV outside the ICUs. To investigate the factors associated with NIV failure (need for intubation or death).

Methods: In this prospective single day observational study, we enrolled adult COVID-19 patients, treated with NIV outside the ICU from thirty-one hospitals in Lombardy, Italy.

Results: We collected data on demographic, clinical characteristics, ventilatory management and patients' outcome. Of 8753 COVID-19 patients present in the hospitals on the study day, 909 (10%) were receiving NIV outside the ICU. 778/909 (85%) patients were treated with Continuous Positive Airway Pressure (CPAP), delivered by helmet in 617 (68%). NIV failed in 300 patients (37.6%), while 498 (62.4%) were discharged alive without intubation. Overall mortality was 25%. NIV failure occurred in 152/284 (53%) patients with a PaO2/FiO2 ratio < 150 mmHg. Higher C-reactive protein, lower PaO2/FiO2, and platelet counts were independently associated with increased risk of NIV failure.

Conclusions: The use of NIV outside the ICUs, in COVID-19 was common, with a predominant use of helmet CPAP, with a rate of success greater than 60% and close to 75% in full treatment patients. C-reactive protein, PaO2/FiO2, platelet counts were independently associated with increased risk of NIV failure. Clinical trial registered with ClinicalTrials.gov (NCT04382235).
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http://dx.doi.org/10.1513/AnnalsATS.202008-1080OCDOI Listing
January 2021

Barotrauma in mechanically ventilated patients with Coronavirus disease 2019: a survey of 38 hospitals in Lombardy, Italy.

Minerva Anestesiol 2021 02 16;87(2):193-198. Epub 2020 Dec 16.

Department of Anesthesiology and Intensive Care Units, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.

Background: The aim was to describe the incidence and risk factors of barotrauma in patients with the Coronavirus disease 2019 (COVID-19) on invasive mechanical ventilation, during the outbreak in our region (Lombardy, Italy).

Methods: The study was an electronic survey open from March 27 to May 2, 2020. Patients with COVID-19 who developed barotrauma while on invasive mechanical ventilation from 61 hospitals of the COVID-19 Lombardy Intensive Care Unit network were involved.

Results: The response rate was 38/61 (62%). The incidence of barotrauma was 145/2041 (7.1%; 95%-CI: 6.1-8.3%). Only a few cases occurred with ventilatory settings that may be considered non-protective such as a plateau airway pressure >35 cmH2O (2/113 [2%]), a driving airway pressure >15 cmH2O (30/113 [27%]), or a tidal volume >8 mL/kg of ideal body weight and a plateau airway pressure >30 cmH2O (12/134 [9%]).

Conclusions: Within the limits of a survey, patients with COVID-19 might be at high risk for barotrauma during invasive (and allegedly lung-protective) mechanical ventilation.
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http://dx.doi.org/10.23736/S0375-9393.20.15002-8DOI Listing
February 2021

Mechanical ventilation in patients with acute brain injury: recommendations of the European Society of Intensive Care Medicine consensus.

Intensive Care Med 2020 Dec 11;46(12):2397-2410. Epub 2020 Nov 11.

Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, 600 N. Wolfe St, Phipps 455, Baltimore, MD, 21287, USA.

Purpose: To provide clinical practice recommendations and generate a research agenda on mechanical ventilation and respiratory support in patients with acute brain injury (ABI).

Methods: An international consensus panel was convened including 29 clinician-scientists in intensive care medicine with expertise in acute respiratory failure, neurointensive care, or both, and two non-voting methodologists. The panel was divided into seven subgroups, each addressing a predefined clinical practice domain relevant to patients admitted to the intensive care unit (ICU) with ABI, defined as acute traumatic brain or cerebrovascular injury. The panel conducted systematic searches and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method was used to evaluate evidence and formulate questions. A modified Delphi process was implemented with four rounds of voting in which panellists were asked to respond to questions (rounds 1-3) and then recommendation statements (final round). Strong recommendation, weak recommendation, or no recommendation were defined when > 85%, 75-85%, and < 75% of panellists, respectively, agreed with a statement.

Results: The GRADE rating was low, very low, or absent across domains. The consensus produced 36 statements (19 strong recommendations, 6 weak recommendations, 11 no recommendation) regarding airway management, non-invasive respiratory support, strategies for mechanical ventilation, rescue interventions for respiratory failure, ventilator liberation, and tracheostomy in brain-injured patients. Several knowledge gaps were identified to inform future research efforts.

Conclusions: This consensus provides guidance for the care of patients admitted to the ICU with ABI. Evidence was generally insufficient or lacking, and research is needed to demonstrate the feasibility, safety, and efficacy of different management approaches.
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http://dx.doi.org/10.1007/s00134-020-06283-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7655906PMC
December 2020

Tranexamic acid in traumatic brain injury: systematic review and meta-analysis trumps a large clinical trial?

Intensive Care Med 2021 Jan 31;47(1):74-76. Epub 2020 Oct 31.

School of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.

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http://dx.doi.org/10.1007/s00134-020-06305-xDOI Listing
January 2021

Acute respiratory failure and mechanical ventilation in the context of the COVID-19 pandemic: why a special issue in ICM?

Intensive Care Med 2020 12 29;46(12):2131-2132. Epub 2020 Oct 29.

Keenan Research Center, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.

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http://dx.doi.org/10.1007/s00134-020-06298-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7594991PMC
December 2020

Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke.

Lancet Neurol 2020 12 21;19(12):1033-1042. Epub 2020 Oct 21.

University Neurosurgical Center Holland, Leiden University Medical Center, Haaglanden Medical Center & Haga Teaching Hospital, Leiden and The Hague, The Netherlands.

Health-care professionals and researchers have a legal and ethical responsibility to inform patients before carrying out diagnostic tests or treatment interventions as part of a clinical study. Interventional research in emergency situations can involve patients with some degree of acute cognitive impairment, as is regularly the case in traumatic brain injury and ischaemic stroke. These patients or their proxies are often unable to provide informed consent within narrow therapeutic time windows. International regulations and national laws are criticised for being inconclusive or restrictive in providing solutions. Currently accepted consent alternatives are deferred consent, exception from consent, or waiver of consent. However, these alternatives appear under-utilised despite being ethically permissible, socially acceptable, and regulatorily compliant. We anticipate that, when the requirements for medical urgency are properly balanced with legal and ethical conduct, the increased use of these alternatives has the potential to improve the efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent.
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http://dx.doi.org/10.1016/S1474-4422(20)30276-3DOI Listing
December 2020

Acute Distress Respiratory Syndrome After Subarachnoid Hemorrhage: Incidence and Impact on the Outcome in a Large Multicenter, Retrospective Cohort.

Neurocrit Care 2020 Oct 20. Epub 2020 Oct 20.

School of Medicine and Surgery, University of Milano - Bicocca, Via Cadore 48, 20900, Monza, Italy.

Background: Respiratory complications are frequently reported after aneurismal subarachnoid hemorrhage (aSAH), even if their association with outcome remains controversial. Acute respiratory distress syndrome (ARDS) is one of the most severe pulmonary complications after aSAH, with a reported incidence ranging from 11 to 50%. This study aims to assess in a large cohort of aSAH patients, during the first week after an intensive care unit (ICU) admission, the incidence of ARDS defined according to the Berlin criteria and its effect on outcome.

Methods: This is a multicentric, retrospective cohort study in 3 European intensive care units. We collected data between January 2009 and December 2017. We included adult patients (≥ 18 years) with a diagnosis of aSAH admitted to the ICU.

Results: A total of 855 patients fulfilled the inclusion criteria. ARDS was assessable in 851 patients. The cumulative incidence of ARDS was 2.2% on the first day since ICU admission, 3.2% on day three, and 3.6% on day seven. At the univariate analysis, ARDS was associated with a poor outcome (p = 0.005) at ICU discharge, and at the multivariable analysis, patients with ARDS showed a worse neurological outcome (Odds ratio = 3.00, 95% confidence interval 1.16-7.72; p = 0.023).

Conclusions: ARDS has a low incidence in the first 7 days of ICU stay after aSAH, but it is associated with worse outcome.
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http://dx.doi.org/10.1007/s12028-020-01115-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7575216PMC
October 2020

Acute Kidney Injury in Traumatic Brain Injury Patients: Results From the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury Study.

Crit Care Med 2021 01;49(1):112-126

Department of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.

Objectives: Acute kidney injury is frequent in polytrauma patients, and it is associated with increased mortality and extended hospital length of stay. However, the specific prevalence of acute kidney injury after traumatic brain injury is less recognized. The present study aims to describe the occurrence rate, risk factors, timing, and association with outcome of acute kidney injury in a large cohort of traumatic brain injury patients.

Design: The Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury is a multicenter, prospective observational, longitudinal, cohort study.

Setting: Sixty-five ICUs across Europe.

Patients: For the present study, we selected 4,509 traumatic brain injury patients with an ICU length of stay greater than 72 hours and with at least two serum creatinine values during the first 7 days of ICU stay.

Measurements And Main Results: We classified acute kidney injury in three stages according to the Kidney Disease Improving Global Outcome criteria: acute kidney injury stage 1 equals to serum creatinine × 1.5-1.9 times from baseline or an increase greater than or equal to 0.3 mg/dL in 48 hours; acute kidney injury stage 2 equals to serum creatinine × 2-2.9 times baseline; acute kidney injury stage 3 equals to serum creatinine × three times baseline or greater than or equal to 4 mg/dL or need for renal replacement therapy. Standard reporting techniques were used to report incidences. A multivariable Cox regression analysis was performed to model the cause-specific hazard of acute kidney injury and its association with the long-term outcome. We included a total of 1,262 patients. The occurrence rate of acute kidney injury during the first week was as follows: acute kidney injury stage 1 equals to 8% (n = 100), acute kidney injury stage 2 equals to 1% (n = 14), and acute kidney injury stage 3 equals to 3% (n = 36). Acute kidney injury occurred early after ICU admission, with a median of 2 days (interquartile range 1-4 d). Renal history (hazard ratio = 2.48; 95% CI, 1.39-4.43; p = 0.002), insulin-dependent diabetes (hazard ratio = 2.52; 95% CI, 1.22-5.197; p = 0.012), hypernatremia (hazard ratio = 1.88; 95% CI, 1.31-2.71; p = 0.001), and osmotic therapy administration (hazard ratio = 2.08; 95% CI, 1.45-2.99; p < 0.001) were significantly associated with the risk of developing acute kidney injury. Acute kidney injury was also associated with an increased ICU length of stay and with a higher probability of 6 months unfavorable Extended Glasgow Outcome Scale and mortality.

Conclusions: Acute kidney injury after traumatic brain injury is an early phenomenon, affecting about one in 10 patients. Its occurrence negatively impacts mortality and neurologic outcome at 6 months. Osmotic therapy use during ICU stay could be a modifiable risk factor.
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http://dx.doi.org/10.1097/CCM.0000000000004673DOI Listing
January 2021

Variability in Serum Sodium Concentration and Prognostic Significance in Severe Traumatic Brain Injury: A Multicenter Observational Study.

Neurocrit Care 2020 Oct 2. Epub 2020 Oct 2.

Intensive Care Unit, Royal Melbourne Hospital, Level 5, B Block, Parkville, VIC, 3050, Australia.

Background/objective: Dysnatremia is common in severe traumatic brain injury (TBI) patients and may contribute to mortality. However, serum sodium variability has not been studied in TBI patients. We hypothesized that such variability would be independently associated with mortality.

Methods: We collected 6-hourly serum sodium levels for the first 7 days of ICU admission from 240 severe TBI patients in 14 neurotrauma ICUs in Europe and Australia. We evaluated the association between daily serum sodium standard deviation (dNa), an index of variability, and 28-day mortality.

Results: Patients were 46 ± 19 years of age with a median initial GCS of 6 [4-8]. Overall hospital mortality was 28%. Hypernatremia and hyponatremia occurred in 64% and 24% of patients, respectively. Over the first 7 days in ICU, serum sodium standard deviation was 2.8 [2.0-3.9] mmol/L. Maximum daily serum sodium standard deviation (dNa) occurred at a median of 2 [1-4] days after admission. There was a significant progressive decrease in dNa over the first 7 days (coefficient - 0.15 95% CI [- 0.18 to - 0.12], p < 0.001). After adjusting for baseline TBI severity, diabetes insipidus, the use of osmotherapy, the occurrence of hypernatremia, and hyponatremia and center, dNa was significantly independently associated with 28-day mortality (HR 1.27 95% CI (1.01-1.61), p = 0.048).

Conclusions: Our study demonstrates that daily serum sodium variability is an independent predictor of 28-day mortality in severe TBI patients. Further prospective investigations are necessary to confirm the significance of sodium variability in larger cohorts of TBI patients and test whether attenuating such variability confers outcome benefits to such patients.
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http://dx.doi.org/10.1007/s12028-020-01118-8DOI Listing
October 2020

Efficacy of acute administration of inhaled argon on traumatic brain injury in mice.

Br J Anaesth 2021 01 22;126(1):256-264. Epub 2020 Sep 22.

Laboratory of Acute Brain Injury and Therapeutic Strategies, Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy. Electronic address:

Background: Whilst there has been progress in supportive treatment for traumatic brain injury (TBI), specific neuroprotective interventions are lacking. Models of ischaemic heart and brain injury show the therapeutic potential of argon gas, but it is still not known whether inhaled argon (iAr) is protective in TBI. We tested the effects of acute administration of iAr on brain oedema, tissue micro-environmental changes, neurological functions, and structural outcome in a mouse model of TBI.

Methods: Anaesthetised adult C57BL/6J mice were subjected to severe TBI by controlled cortical impact. Ten minutes after TBI, the mice were randomised to 24 h treatments with iAr 70%/O 30% or air (iCtr). Sensorimotor deficits were evaluated up to 6 weeks post-TBI by three independent tests. Cognitive function was evaluated by Barnes maze test at 4 weeks. MRI was done to examine brain oedema at 3 days and white matter damage at 5 weeks. Microglia/macrophages activation and functional commitment were evaluated at 1 week after TBI by immunohistochemistry.

Results: iAr significantly accelerated sensorimotor recovery and improved cognitive deficits 1 month after TBI, with less white matter damage in the ipsilateral fimbria and body of the corpus callosum. Early changes underpinning protection included a reduction of pericontusional vasogenic oedema and of the inflammatory response. iAr significantly reduced microglial activation with increases in ramified cells and the M2-like marker YM1.

Conclusions: iAr accelerates recovery of sensorimotor function and improves cognitive and structural outcome 1 month after severe TBI in adult mice. Early effects include a reduction of brain oedema and neuroinflammation in the contused tissue.
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http://dx.doi.org/10.1016/j.bja.2020.08.027DOI Listing
January 2021

Prehospital Management of Traumatic Brain Injury across Europe: A CENTER-TBI Study.

Prehosp Emerg Care 2020 Oct 1:1-15. Epub 2020 Oct 1.

Received May 5, 2020 from Department of Public Health, Erasmus Medical Center, Rotterdam, the Netherlands (BYG, CAS, HFL, EWS); Department of Pathophysiology and Transplantation, Milan University, Milan, Italy (NS); School of Medicine and Surgery, University Milano - Bicocca, Milan, Italy (GC); Department of Neurosurgery, Antwerp University Hospital and University of Antwerp, Belgium (AIRM); Division of Anaesthesia, University of Cambridge, Addenbrooke's Hospital, Cambridge, UK (AE, DKM); Institute of Medical Psychology and Medical Sociology, Universitätsmedizin Göttingen, Göttingen (NVS); Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands (EWS); Division of Physiology, University of Stirling, Stirling, UK (LW); Center for Urgent and Emergency Care Research, Health Services Research Section, School of Health and Related Research, University of Sheffield, Sheffield, UK (FEL); Emergency Department, Salford Royal Hospital, Salford, UK (FEL). Revision received August 23, 2020; accepted for publication August 24, 2020.

Background: Prehospital care for traumatic brain injury (TBI) is important to prevent secondary brain injury. We aim to compare prehospital care systems within Europe and investigate the association of system characteristics with the stability of patients at hospital arrival.

Methods: We studied TBI patients who were transported to CENTER-TBI centers, a pan-European, prospective TBI cohort study, by emergency medical services between 2014 and 2017. The association of demographic factors, injury severity, situational factors, and interventions associated with on-scene time was assessed using linear regression. We used mixed effects models to investigate the case mix adjusted variation between countries in prehospital times and interventions. The case mix adjusted impact of on-scene time and interventions on hypoxia (oxygen saturation <90%) and hypotension (systolic blood pressure <100mmHg) at hospital arrival was analyzed with logistic regression.

Results: Among 3878 patients, the greatest driver of longer on-scene time was intubation (+8.3 min, 95% CI: 5.6-11.1). Secondary referral was associated with shorter on-scene time (-5.0 min 95% CI: -6.2- -3.8). Between countries, there was a large variation in response (range: 12-25 min), on-scene (range: 16-36 min) and travel time (range: 15-32 min) and in prehospital interventions. These variations were not explained by patient factors such as conscious level or severity of injury (expected OR between countries: 1.8 for intubation, 1.8 for IV fluids, 2.0 for helicopter). On-scene time was not associated with the regional EMS policy (p= 0.58). Hypotension and/or hypoxia were seen in 180 (6%) and 97 (3%) patients in the overall cohort and in 13% and 7% of patients with severe TBI (GCS <8). The largest association with secondary insults at hospital arrival was with major extracranial injury: the OR was 3.6 (95% CI: 2.6-5.0) for hypotension and 4.4 (95% CI: 2.9-6.7) for hypoxia.

Discussion: Hypoxia and hypotension continue to occur in patients who suffer a TBI, and remain relatively common in severe TBI. Substantial variation in prehospital care exists for patients after TBI in Europe, which is only partially explained by patient factors.
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http://dx.doi.org/10.1080/10903127.2020.1817210DOI Listing
October 2020

Determination of Brain Death/Death by Neurologic Criteria: The World Brain Death Project.

JAMA 2020 Sep;324(11):1078-1097

University of Southern California, Los Angeles.

Importance: There are inconsistencies in concept, criteria, practice, and documentation of brain death/death by neurologic criteria (BD/DNC) both internationally and within countries.

Objective: To formulate a consensus statement of recommendations on determination of BD/DNC based on review of the literature and expert opinion of a large multidisciplinary, international panel.

Process: Relevant international professional societies were recruited to develop recommendations regarding determination of BD/DNC. Literature searches of the Cochrane, Embase, and MEDLINE databases included January 1, 1992, through April 2020 identified pertinent articles for review. Because of the lack of high-quality data from randomized clinical trials or large observational studies, recommendations were formulated based on consensus of contributors and medical societies that represented relevant disciplines, including critical care, neurology, and neurosurgery.

Evidence Synthesis: Based on review of the literature and consensus from a large multidisciplinary, international panel, minimum clinical criteria needed to determine BD/DNC in various circumstances were developed.

Recommendations: Prior to evaluating a patient for BD/DNC, the patient should have an established neurologic diagnosis that can lead to the complete and irreversible loss of all brain function, and conditions that may confound the clinical examination and diseases that may mimic BD/DNC should be excluded. Determination of BD/DNC can be done with a clinical examination that demonstrates coma, brainstem areflexia, and apnea. This is seen when (1) there is no evidence of arousal or awareness to maximal external stimulation, including noxious visual, auditory, and tactile stimulation; (2) pupils are fixed in a midsize or dilated position and are nonreactive to light; (3) corneal, oculocephalic, and oculovestibular reflexes are absent; (4) there is no facial movement to noxious stimulation; (5) the gag reflex is absent to bilateral posterior pharyngeal stimulation; (6) the cough reflex is absent to deep tracheal suctioning; (7) there is no brain-mediated motor response to noxious stimulation of the limbs; and (8) spontaneous respirations are not observed when apnea test targets reach pH <7.30 and Paco2 ≥60 mm Hg. If the clinical examination cannot be completed, ancillary testing may be considered with blood flow studies or electrophysiologic testing. Special consideration is needed for children, for persons receiving extracorporeal membrane oxygenation, and for those receiving therapeutic hypothermia, as well as for factors such as religious, societal, and cultural perspectives; legal requirements; and resource availability.

Conclusions And Relevance: This report provides recommendations for the minimum clinical standards for determination of brain death/death by neurologic criteria in adults and children with clear guidance for various clinical circumstances. The recommendations have widespread international society endorsement and can serve to guide professional societies and countries in the revision or development of protocols and procedures for determination of brain death/death by neurologic criteria, leading to greater consistency within and between countries.
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http://dx.doi.org/10.1001/jama.2020.11586DOI Listing
September 2020

The role of frailty in COVID-19 patients.

Intensive Care Med 2020 10 1;46(10):1958-1959. Epub 2020 Aug 1.

School of Medicine and Surgery, Acute Geriatric Unit, University of Milano-Bicocca, San Gerardo Hospital, Monza, Italy.

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http://dx.doi.org/10.1007/s00134-020-06204-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395575PMC
October 2020

Incidence, Risk Factors, and Effects on Outcome of Ventilator-Associated Pneumonia in Patients With Traumatic Brain Injury: Analysis of a Large, Multicenter, Prospective, Observational Longitudinal Study.

Chest 2020 Dec 4;158(6):2292-2303. Epub 2020 Jul 4.

School of Medicine and Surgery, University of Milan-Bicocca, Milan. Electronic address:

Background: No large prospective data, to our knowledge, are available on ventilator-associated pneumonia (VAP) in patients with traumatic brain injury (TBI).

Research Question: To evaluate the incidence, timing, and risk factors of VAP after TBI and its effect on patient outcome.

Study Design And Methods: This analysis is of the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury data set, from a large, multicenter, prospective, observational study including patients with TBI admitted to European ICUs, receiving mechanical ventilation for ≥ 48 hours and with an ICU length of stay (LOS) ≥ 72 hours. Characteristics of patients with VAP vs characteristics of patients without VAP were compared, and outcome was assessed at 6 months after injury by using the Glasgow Outcome Scale Extended.

Results: The study included 962 patients: 196 (20.4%) developed a VAP at a median interval of 5 days (interquartile range [IQR], 3-7 days) after intubation. Patients who developed VAP were younger (median age, 39.5 [IQR, 25-55] years vs 51 [IQR, 30-66] years; P < .001), with a higher incidence of alcohol abuse (36.6% vs 27.6%; P = .026) and drug abuse (10.1% vs 4.2%; P = .009), more frequent thoracic trauma (53% vs 43%; P = .014), and more episodes of respiratory failure during ICU stay (69.9% vs 28.1%; P < .001). Age (hazard ratio [HR], 0.99; 95% CI, 0.98-0.99; P = .001), chest trauma (HR, 1.4; 95% CI, 1.03-1.90; P = .033), histamine-receptor antagonist intake (HR, 2.16; 95% CI, 1.37-3.39; P = .001), and antibiotic prophylaxis (HR, 0.69; 95% CI, 0.50-0.96; P = .026) were associated with the risk of VAP. Patients with VAP had a longer duration of mechanical ventilation (median, 15 [IQR, 10-22] days vs 8 [IQR, 5-14] days; P < .001) and ICU LOS (median, 20 [IQR, 14-29] days vs 13 [IQR, 8-21] days; P < .001). However, VAP was not associated with increased mortality or worse neurological outcome. Overall mortality at 6 months was 22%.

Interpretation: VAP occurs less often than previously described in patients after TBI and has a detrimental effect on ICU LOS but not on mortality and neurological outcome.

Clinical Trial Registration: ClinicalTrials.gov; No.: NCT02210221; URL: www.clinicaltrials.gov.
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http://dx.doi.org/10.1016/j.chest.2020.06.064DOI Listing
December 2020

Critical care journals during the COVID-19 pandemic: challenges and responsibilities.

Intensive Care Med 2020 Aug 6;46(8):1521-1523. Epub 2020 Jul 6.

Past Editor in Chief, Intensive Care Medicine, Médecine Intensive Et Réanimation, APHP, Hôpital Saint-Louis, Paris University, Paris, France.

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http://dx.doi.org/10.1007/s00134-020-06155-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7335762PMC
August 2020

The Agents Intervening against Delirium in the Intensive Care Unit Trial (AID-ICU trial): A detailed statistical analysis plan.

Acta Anaesthesiol Scand 2020 10 13;64(9):1357-1364. Epub 2020 Jul 13.

Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.

Background: The AID-ICU trial aims to assess the benefits and harms of haloperidol for the treatment of delirium in acutely admitted, adult intensive care unit (ICU) patients. This paper describes the detailed statistical analysis plan for the primary publication of results from the AID-ICU trial.

Methods: The AID-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomized, blinded, parallel-group trial allocating 1000 adult ICU patients with manifest delirium 1:1 to haloperidol or placebo. The primary outcome measure is days alive and out of hospital within 90 days post-randomization. Secondary outcome measures are days alive without delirium or coma, serious adverse reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomization. Statistical analysis will be conducted in accordance with the current pre-specified statistical analysis plan. One formal interim analysis will be performed. The primary outcome will be adjusted for stratification variables (site and delirium motor subtype) and compared between treatment groups using a likelihood ratio test described by Jensen et al A secondary analysis will be conducted with additional adjustment of the primary outcome for prognostic variables at baseline. The primary conclusion of the trial will be based on the intention-to-treat analysis of the primary outcome adjusted for stratification variables.

Conclusion: The AID-ICU trial will provide important, high-quality data on the benefits and harms of treatment with haloperidol in acutely admitted, adult patients with manifest delirium in the ICU.
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http://dx.doi.org/10.1111/aas.13661DOI Listing
October 2020

Managing ICU surge during the COVID-19 crisis: rapid guidelines.

Intensive Care Med 2020 Jul 8;46(7):1303-1325. Epub 2020 Jun 8.

London's Air Ambulance, Royal London Hospital, Barts NHS Health Trust, Whitechapel Rd, Whitechapel, London, E1 1FR, England, UK.

Given the rapidly changing nature of COVID-19, clinicians and policy makers require urgent review and summary of the literature, and synthesis of evidence-based guidelines to inform practice. The WHO advocates for rapid reviews in these circumstances. The purpose of this rapid guideline is to provide recommendations on the organizational management of intensive care units caring for patients with COVID-19 including: planning a crisis surge response; crisis surge response strategies; triage, supporting families, and staff.
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http://dx.doi.org/10.1007/s00134-020-06092-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7276667PMC
July 2020

COVID-19: 10 things I wished I'd known some months ago.

Intensive Care Med 2020 Jul 3;46(7):1449-1452. Epub 2020 Jun 3.

School of Medicine and Surgery, University of Milano - Bicocca, Milan, Italy.

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http://dx.doi.org/10.1007/s00134-020-06098-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7268592PMC
July 2020

Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study.

J Crit Care 2020 10 25;59:6-15. Epub 2020 May 25.

Department of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands; Department of Medical Ethics and Philosophy of Medicine, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands. Electronic address:

Purpose: Enrolling traumatic brain injury (TBI) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in European and national legislation, which allows procedural variation and bias. We aimed to quantify variations in informed consent policy and practice.

Methods: Variation was explored in the CENTER-TBI study. Policies were reported by using a questionnaire and national legislation. Data on used informed consent procedures were available for 4498 patients from 57 centres across 17 European countries.

Results: Variation in the use of informed consent procedures was found between and within EU member states. Proxy informed consent (N = 1377;64%) was the most frequently used type of consent in the ICU, followed by patient informed consent (N = 426;20%) and deferred consent (N = 334;16%). Deferred consent was only actively used in 15 centres (26%), although it was considered valid in 47 centres (82%).

Conclusions: Alternatives to patient consent are essential for TBI research. While there seems to be concordance amongst national legislations, there is regional variability in institutional practices with respect to the use of different informed consent procedures. Variation could be caused by several reasons, including inconsistencies in clear legislation or knowledge of such legislation amongst researchers.
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http://dx.doi.org/10.1016/j.jcrc.2020.05.004DOI Listing
October 2020

Frailty index predicts poor outcome in COVID-19 patients.

Intensive Care Med 2020 08 25;46(8):1634-1636. Epub 2020 May 25.

School of Medicine and Surgery, University of Milano - Bicocca, Milan, Italy.

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http://dx.doi.org/10.1007/s00134-020-06087-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7246290PMC
August 2020

How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study.

BMC Med Ethics 2020 05 12;21(1):36. Epub 2020 May 12.

Department of Intensive Care, Erasmus MC - University Medical Centre Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, the Netherlands.

Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency.

Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe.

Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074).

Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.
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http://dx.doi.org/10.1186/s12910-020-00480-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7216427PMC
May 2020