Publications by authors named "Michael S D Agus"

68 Publications

Performance of an Electronic Decision Support System as a Therapeutic Intervention During a Multicenter PICU Clinical Trial: Heart and Lung Failure-Pediatric Insulin Titration trial (HALF-PINT).

Chest 2021 Apr 29. Epub 2021 Apr 29.

Department of Pediatrics, Division of Medical Critical Care, Boston Children's Hospital, Boston, MA; Department of Pediatrics, Harvard Medical School, Boston, MA.

Background: The use of electronic clinical decision support (CDS) systems for pediatric critical care trials is rare. We sought to describe in detail the use of a CDS tool (Children's Hospital Euglycemia for Kids Spreadsheet [CHECKS), for the management of hyperglycemia during the 32 multicenter Heart And Lung Failure-Pediatric Insulin Titration trial.

Research Question: In critically ill pediatric patients who were treated with CHECKS, how was user compliance associated with outcomes; and what patient and clinician factors might account for the observed differences in CHECKS compliance?

Study Design And Methods: During an observational retrospective study of compliance with a CDS tool used during a prospective randomized controlled trial, we compared patients with high and low CHECKS compliance. We investigated the association between compliance and blood glucose metrics. We describe CHECKS and use a computer interface analysis framework (the user, function, representation, task analysis framework) to categorize user interactions. We discuss implications for future randomized controlled trials.

Results: Over a 4.5-year period, 658 of 698 children were treated with the CHECKS protocol for ≥24 hours with a median of 119 recommendations per patient. Compliance per patient was high (median, 99.5%), with only 30 patients having low compliance (<90%). Patients with low compliance were from 16 of 32 sites, younger (P = .02), and less likely to be on inotropic support (P = .04). They were more likely to be have been assigned randomly to the lower blood glucose target (80% vs 48%; P < .001) and to have spent a shorter time (53% vs 75%; P < .001) at the blood glucose target. Overrides (classified by the user, function, representation, task analysis framework), were largely (89%) due to the user with patient factors contributed 29% of the time.

Interpretation: The use of CHECKS for the Heart And Lung Failure-Pediatric Insulin Titration trial resulted in a highly reproducible and explicit method for the management of hyperglycemia in critically ill children across varied environments. CDS systems represent an important mechanism for conducting explicit complex pediatric critical care trials.

Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01565941, registered March 29 2012; https://clinicaltrials.gov/ct2/show/NCT01565941?term=HALF-PINT&draw=2&rank=1.
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http://dx.doi.org/10.1016/j.chest.2021.04.049DOI Listing
April 2021

Enabling a learning healthcare system with automated computer protocols that produce replicable and personalized clinician actions.

J Am Med Inform Assoc 2021 Jun;28(6):1330-1344

Department of Pediatrics, Perelman School of Medicine.

Clinical decision-making is based on knowledge, expertise, and authority, with clinicians approving almost every intervention-the starting point for delivery of "All the right care, but only the right care," an unachieved healthcare quality improvement goal. Unaided clinicians suffer from human cognitive limitations and biases when decisions are based only on their training, expertise, and experience. Electronic health records (EHRs) could improve healthcare with robust decision-support tools that reduce unwarranted variation of clinician decisions and actions. Current EHRs, focused on results review, documentation, and accounting, are awkward, time-consuming, and contribute to clinician stress and burnout. Decision-support tools could reduce clinician burden and enable replicable clinician decisions and actions that personalize patient care. Most current clinical decision-support tools or aids lack detail and neither reduce burden nor enable replicable actions. Clinicians must provide subjective interpretation and missing logic, thus introducing personal biases and mindless, unwarranted, variation from evidence-based practice. Replicability occurs when different clinicians, with the same patient information and context, come to the same decision and action. We propose a feasible subset of therapeutic decision-support tools based on credible clinical outcome evidence: computer protocols leading to replicable clinician actions (eActions). eActions enable different clinicians to make consistent decisions and actions when faced with the same patient input data. eActions embrace good everyday decision-making informed by evidence, experience, EHR data, and individual patient status. eActions can reduce unwarranted variation, increase quality of clinical care and research, reduce EHR noise, and could enable a learning healthcare system.
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http://dx.doi.org/10.1093/jamia/ocaa294DOI Listing
June 2021

Impact of a Clinical Documentation Integrity Program on Severity of Illness of Expired Patients.

Hosp Pediatr 2021 Mar 4;11(3):298-302. Epub 2021 Feb 4.

Division of Critical Care Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts;

Background: As payment models continue to move toward value-driven care, the quality of documentation has become more important than ever. Clinical Documentation Integrity (CDI) programs can aid in the documentation of diagnoses that are specific and consistent throughout the medical record, which leads to accurate code assignment, better understanding of patient complexity, and improved facility reimbursement.

Methods: An interrupted time series analysis was conducted by using a segmented regression model to estimate the impact of our hospital's CDI program on perceived patient complexity using severity of illness stratification, observed to expected mortality ratio and case-mix index. Patients who died during the admission were chosen to limit our analysis to patients with the highest severity of illness.

Results: A total of 206 patients who had died while inpatient at our 400 bed children's hospital were included. There was a 15.7% increase in patients who were final coded with the highest level of severity of illness after our CDI program launched compared with those patients admitted before program inception. The hospital case-mix index for inpatient cases increased 25% from 2011 to 2017. There was a 44% decrease in the observed to expected mortality ratio.

Discussion: A CDI program can have a significant impact, as evidenced by our ability to show complexity gains on some of the sickest patients by supporting documentation of precise, accurate diagnoses. In turn, this may allow for better understanding of the complexity of our patient population and support appropriate reimbursement and payer contract negotiations.
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http://dx.doi.org/10.1542/hpeds.2020-000851DOI Listing
March 2021

Life-Threatening Hemoptysis in a Pediatric Referral Center.

Crit Care Med 2021 03;49(3):e291-e303

Department of Cardiology, Boston Children's Hospital, Boston, MA.

Objectives: Hemoptysis is uncommon in children, even among the critically ill, with a paucity of epidemiological data to inform clinical decision-making. We describe hemoptysis-associated ICU admissions, including those who were critically ill at hemoptysis onset or who became critically ill as a result of hemoptysis, and identify predictors of mortality.

Design: Retrospective cohort study. Demographics, hemoptysis location, and management were collected. Pediatric Logistic Organ Dysfunction-2 score within 24 hours of hemoptysis described illness severity. Primary outcome was inhospital mortality.

Setting: Quaternary pediatric referral center between July 1, 2010, and June 30, 2017.

Patients: Medical/surgical (PICU), cardiac ICU, and term neonatal ICU admissions with hemoptysis during or within 24 hours of ICU admission.

Interventions: No intervention.

Measurements And Main Results: There were 326 hemoptysis-associated ICU admissions in 300 patients. Most common diagnoses were cardiac (46%), infection (15%), bronchiectasis (10%), and neoplasm (7%). Demographics, interventions, and outcomes differed by diagnostic category. Overall, 79 patients (26%) died inhospital and 109 (36%) had died during follow-up (survivor mean 2.8 ± 1.9 yr). Neoplasm, bronchiectasis, renal dysfunction, inhospital hemoptysis onset, and higher Pediatric Logistic Organ Dysfunction-2 score were independent risk factors for inhospital mortality (p < 0.02). Pharmacotherapy (32%), blood products (29%), computerized tomography angiography (26%), bronchoscopy (44%), and cardiac catheterization (36%) were common. Targeted surgical interventions were rare. Of survivors, 15% were discharged with new respiratory support. Of the deaths, 93 (85%) occurred within 12 months of admission. For patients surviving 12 months, 5-year survival was 87% (95% CI, 78-92) and mortality risk remained only for those with neoplasm (log-rank p = 0.001).

Conclusions: We observed high inhospital mortality from hemoptysis-associated ICU admissions. Mortality was independently associated with hemoptysis onset location, underlying diagnosis, and severity of critical illness at event. Additional mortality was observed in the 12-month posthospital discharge. Future directions include further characterization of this vulnerable population and management recommendations for life-threatening pediatric hemoptysis incorporating underlying disease pathophysiology.
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http://dx.doi.org/10.1097/CCM.0000000000004822DOI Listing
March 2021

Nurses' Perceptions of Workload Burden in Pediatric Critical Care.

Am J Crit Care 2021 01;30(1):27-35

Martha A. Q. Curley is the Ruth M. Colket Endowed Chair in Pediatric Nursing, Department of Family and Community Health, School of Nursing, University of Pennsylvania, Department of Anesthesiology and Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, and Research Institute, Children's Hospital of Philadelphia.

Background: Quantifying nurses' perceptions of workload burden when managing critically ill patients is essential for designing interventions to ease nurses' workday.

Objectives: To explore pediatric intensive care unit (PICU) nurses' perceptions of their workload when caring for critically ill patients and managing protocolized therapies.

Methods: This study was embedded in a multicenter randomized clinical trial where participants were assigned to receive either lower-target or higher-target glucose control. Nurses from 35 participating PICUs completed a baseline survey containing questions about their perceptions of PICU workload in general. They completed an intervention survey after caring for a study patient. Two workload measurement instruments, the Subjective Workload Assessment Technique (SWAT) and the National Aeronautics and Space Administration-Task Load Index (NASA-TLX), were embedded in these surveys.

Results: Baseline surveys were completed by 1476 PICU nurses, predominantly female with a bachelor's degree and a median (interquartile range) of 6 (3-11) years of nursing experience and 4 (2-9) years of PICU experience. Most nurses (65%) rated time burden as the most important component of their workload, followed by cognitive (22%) or psychological stress (13%) burden. Work performance was selected most often as contributing to workload, followed by cognitive demand, time pressure, effort, and physical demand. Intervention surveys were completed by 73% of enrolled participants (505 of 693). Nurses managing the lower glucose target group reported higher levels of workload burden as measured by the SWAT (P = .002) and NASA-TLX (P < .001).

Conclusions: This study describes the workload burden perceived by PICU nurses when managing critically ill patients in general and when managing protocolized therapies.
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http://dx.doi.org/10.4037/ajcc2021725DOI Listing
January 2021

Perspective of the Surviving Sepsis Campaign on the Management of Pediatric Sepsis in the Era of Coronavirus Disease 2019.

Pediatr Crit Care Med 2020 11;21(11):e1031-e1037

British Columbia Children's Hospital, Vancouver, BC, Canada.

Severe acute respiratory syndrome coronavirus 2 is a novel cause of organ dysfunction in children, presenting as either coronavirus disease 2019 with sepsis and/or respiratory failure or a hyperinflammatory shock syndrome. Clinicians must now consider these diagnoses when evaluating children for septic shock and sepsis-associated organ dysfunction. The Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-associated Organ Dysfunction in Children provide an appropriate framework for the early recognition and initial resuscitation of children with sepsis or septic shock caused by all pathogens, including severe acute respiratory syndrome coronavirus 2. However, the potential benefits of select adjunctive therapies may differ from non-coronavirus disease 2019 sepsis.
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http://dx.doi.org/10.1097/PCC.0000000000002553DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7597755PMC
November 2020

A Novel Framework Using Remote Telesimulation With Standardized Parents to Improve Research Staff Preparedness for Informed Consent in Pediatric Critical Care Research.

Pediatr Crit Care Med 2020 12;21(12):e1042-e1051

Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA.

Objectives: The Heart And Lung Failure-Pediatric INsulin Titration study was experiencing poor subject enrollment due to low rates of informed consent. Heart And Lung Failure-Pediatric INsulin Titration investigators collaborated with the Perelman School of Medicine Standardized Patient Program to explore the novel use of telesimulation with standardized parents to train research staff to approach parents of critically ill children for informed consent. We describe the feasibility, learner acceptance, and financial costs of this novel intervention and performed a post hoc analysis to determine if this intervention improved study consent rates.

Design: Observational, comparative effectiveness study.

Setting: Heart And Lung Failure-Pediatric INsulin Titration study enrolling sites.

Subjects: Research staff (at the remote site).

Interventions: Individual 90-minute Skype telesimulation sessions with standardized parent and simulation facilitator (at the training site).

Measurements And Main Results: Forty telesimulation sessions with 79 Heart And Lung Failure-Pediatric INsulin Titration research staff (participants) at 24 remote sites were conducted. Despite some technical delays, 40 out of 40 simulations (100%) were completed. Based on feedback surveys, 100% of respondents agreed (81% strongly agreed) that telesimulation sessions achieved intended learning objectives to prepare research staff to approach parents of eligible critically ill children to obtain informed consent. Additionally, 100% of respondents agreed (74% strongly agreed) that they would use lessons from the telesimulation when approaching parents to obtain informed consent for research. Telesimulation with standardized parents achieved lower financial costs (approximately $85 per session) compared with traditional in-person site visits for training research staff. There was no significant improvement in study consent rates with the intervention (pre: 46% vs post: 48%; p = 0.78).

Conclusions: Remote telesimulation with standardized parents is feasible, acceptable, and associated with lower financial costs to prepare research staff to obtain informed consent from parents of critically ill children eligible for clinical research trials. Despite this novel approach, Heart And Lung Failure-Pediatric INsulin Titration study consent rates did not improve, suggesting that other factors influence parental consent and decision making in complex multicenter clinical research trials.
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http://dx.doi.org/10.1097/PCC.0000000000002484DOI Listing
December 2020

Clinical Manifestations and Outcomes of Critically Ill Children and Adolescents with Coronavirus Disease 2019 in New York City.

J Pediatr 2020 Jul 16. Epub 2020 Jul 16.

Division of Critical Care Medicine, Department of Pediatrics, Children's Hospital at Montefiore, Bronx, NY; Division of Cardiology, Department of Pediatrics, Children's Hospital at Montefiore, Bronx, NY. Electronic address:

Objectives: To describe the clinical manifestations and outcomes of critically ill children with coronavirus disease-19 (COVID-19) in New York City.

Study Design: Retrospective observational study of children 1 month to 21 years admitted March 14 to May 2, 2020, to 9 New York City pediatric intensive care units (PICUs) with severe acute respiratory syndrome coronavirus 2 infection.

Results: Of 70 children admitted to PICUs, median age was 15 (IQR 9, 19) years; 61.4% male; 38.6% Hispanic; 32.9% black; and 74.3% with comorbidities. Fever (72.9%) and cough (71.4%) were the common presenting symptoms. Twelve patients (17%) met severe sepsis criteria; 14 (20%) required vasopressor support; 21 (30%) developed acute respiratory distress syndrome (ARDS); 9 (12.9%) met acute kidney injury criteria; 1 (1.4%) required renal-replacement therapy, and 2 (2.8%) had cardiac arrest. For treatment, 27 (38.6%) patients received hydroxychloroquine; 13 (18.6%) remdesivir; 23 (32.9%) corticosteroids; 3 (4.3%) tocilizumab; and 1 (1.4%) anakinra; no patient was given immunoglobulin or convalescent plasma. Forty-nine (70%) patients required respiratory support: 14 (20.0%) noninvasive mechanical ventilation, 20 (28.6%) invasive mechanical ventilation (IMV), 7 (10%) prone position, 2 (2.8%) inhaled nitric oxide, and 1 (1.4%) extracorporeal membrane oxygenation. Nine (45%) of the 20 patients requiring IMV were extubated by day 14 with median IMV duration of 218 (IQR 79, 310.4) hours. Presence of ARDS was significantly associated with duration of PICU and hospital stay, and lower probability of PICU and hospital discharge at hospital day 14 (P < .05 for all).

Conclusions: Critically ill children with COVID-19 predominantly are adolescents, have comorbidities, and require some form of respiratory support. The presence of ARDS is significantly associated with prolonged PICU and hospital stay.
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http://dx.doi.org/10.1016/j.jpeds.2020.07.039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7363610PMC
July 2020

Corticosteroids probably reduce sepsis-related 28-day mortality in adults - unclear effect in children.

Authors:
Michael S D Agus

J Pediatr 2020 05;220:264-267

Harvard Medical School, Boston, Massachusetts.

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http://dx.doi.org/10.1016/j.jpeds.2020.02.067DOI Listing
May 2020

Standardized Protocol Is Associated With a Decrease in Continuous Albuterol Use and Length of Stay in Critical Status Asthmaticus.

Pediatr Crit Care Med 2020 05;21(5):451-460

Division of Medicine Critical Care, Boston Children's Hospital, Harvard Medical School Boston, MA.

Objectives: The primary aim of this study was to reduce duration of continuous albuterol and hospital length of stay in critically ill children with severe status asthmaticus.

Design: Observational prospective study from September 2012 to May 2016.

Setting: Medicine ICU and intermediate care unit.

Patients: Children greater than 2 years old with admission diagnosis of status asthmaticus admitted on continuous albuterol and managed via a standardized protocol.

Interventions: The protocol was an iterative algorithm for escalation and weaning of therapy. The algorithm underwent three revisions. Iteration 1 concentrated on reducing duration on continuous albuterol; iteration 2 concentrated on reducing hospital length of stay; and iteration 3 concentrated on reducing helium-oxygen delivered continuous albuterol. Balancing measures included adverse events and readmissions.

Measurements And Results: Three-hundred eighty-five patients were treated as follows: 123, 138, and 124 in iterations 1, 2, and 3, respectively. Baseline data was gathered from an additional 150 patients prior to protocol implementation. There was no difference in median age (6 vs 8 vs 7 vs 7 yr; p = 0.130), asthma severity score (9 vs 9 vs 9 vs 9; p = 0.073), or female gender (42% vs 41% vs 43% vs 48%; p = 0.757). Using statistical process control charts, the mean duration on continuous albuterol decreased from 24.9 to 17.5 hours and the mean hospital length of stay decreased from 76 to 49 hours. There was no difference in adverse events (0% vs 1% vs 4% vs 0%; p = 0.054) nor in readmissions (0% vs 0% vs 1% vs 2%; p = 0.254).

Conclusions: Implementation of a quality improvement protocol in critically ill patients with status asthmaticus was associated with a decrease in continuous albuterol duration and hospital length of stay.
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http://dx.doi.org/10.1097/PCC.0000000000002239DOI Listing
May 2020

Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children.

Pediatr Crit Care Med 2020 02;21(2):e52-e106

Radboud University Medical Centre, Nijmegen, The Netherlands.

Objectives: To develop evidence-based recommendations for clinicians caring for children (including infants, school-aged children, and adolescents) with septic shock and other sepsis-associated organ dysfunction.

Design: A panel of 49 international experts, representing 12 international organizations, as well as three methodologists and three public members was convened. Panel members assembled at key international meetings (for those panel members attending the conference), and a stand-alone meeting was held for all panel members in November 2018. A formal conflict-of-interest policy was developed at the onset of the process and enforced throughout. Teleconferences and electronic-based discussion among the chairs, co-chairs, methodologists, and group heads, as well as within subgroups, served as an integral part of the guideline development process.

Methods: The panel consisted of six subgroups: recognition and management of infection, hemodynamics and resuscitation, ventilation, endocrine and metabolic therapies, adjunctive therapies, and research priorities. We conducted a systematic review for each Population, Intervention, Control, and Outcomes question to identify the best available evidence, statistically summarized the evidence, and then assessed the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. We used the evidence-to-decision framework to formulate recommendations as strong or weak, or as a best practice statement. In addition, "in our practice" statements were included when evidence was inconclusive to issue a recommendation, but the panel felt that some guidance based on practice patterns may be appropriate.

Results: The panel provided 77 statements on the management and resuscitation of children with septic shock and other sepsis-associated organ dysfunction. Overall, six were strong recommendations, 52 were weak recommendations, and nine were best-practice statements. For 13 questions, no recommendations could be made; but, for 10 of these, "in our practice" statements were provided. In addition, 49 research priorities were identified.

Conclusions: A large cohort of international experts was able to achieve consensus regarding many recommendations for the best care of children with sepsis, acknowledging that most aspects of care had relatively low quality of evidence resulting in the frequent issuance of weak recommendations. Despite this challenge, these recommendations regarding the management of children with septic shock and other sepsis-associated organ dysfunction provide a foundation for consistent care to improve outcomes and inform future research.
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http://dx.doi.org/10.1097/PCC.0000000000002198DOI Listing
February 2020

Surviving sepsis campaign international guidelines for the management of septic shock and sepsis-associated organ dysfunction in children.

Intensive Care Med 2020 02;46(Suppl 1):10-67

Radboud University Medical Centre, Nijmegen, The Netherlands.

Objectives: To develop evidence-based recommendations for clinicians caring for children (including infants, school-aged children, and adolescents) with septic shock and other sepsis-associated organ dysfunction.

Design: A panel of 49 international experts, representing 12 international organizations, as well as three methodologists and three public members was convened. Panel members assembled at key international meetings (for those panel members attending the conference), and a stand-alone meeting was held for all panel members in November 2018. A formal conflict-of-interest policy was developed at the onset of the process and enforced throughout. Teleconferences and electronic-based discussion among the chairs, co-chairs, methodologists, and group heads, as well as within subgroups, served as an integral part of the guideline development process.

Methods: The panel consisted of six subgroups: recognition and management of infection, hemodynamics and resuscitation, ventilation, endocrine and metabolic therapies, adjunctive therapies, and research priorities. We conducted a systematic review for each Population, Intervention, Control, and Outcomes question to identify the best available evidence, statistically summarized the evidence, and then assessed the quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. We used the evidence-to-decision framework to formulate recommendations as strong or weak, or as a best practice statement. In addition, "in our practice" statements were included when evidence was inconclusive to issue a recommendation, but the panel felt that some guidance based on practice patterns may be appropriate.

Results: The panel provided 77 statements on the management and resuscitation of children with septic shock and other sepsis-associated organ dysfunction. Overall, six were strong recommendations, 49 were weak recommendations, and nine were best-practice statements. For 13 questions, no recommendations could be made; but, for 10 of these, "in our practice" statements were provided. In addition, 52 research priorities were identified.

Conclusions: A large cohort of international experts was able to achieve consensus regarding many recommendations for the best care of children with sepsis, acknowledging that most aspects of care had relatively low quality of evidence resulting in the frequent issuance of weak recommendations. Despite this challenge, these recommendations regarding the management of children with septic shock and other sepsis-associated organ dysfunction provide a foundation for consistent care to improve outcomes and inform future research.
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http://dx.doi.org/10.1007/s00134-019-05878-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7095013PMC
February 2020

Long-Term Neurobehavioral and Quality of Life Outcomes of Critically Ill Children after Glycemic Control.

J Pediatr 2020 03 3;218:57-63.e5. Epub 2020 Jan 3.

Division of Medical Critical Care, Department of Pediatrics, Boston Children's Hospital and Harvard Medical School, Boston, MA.

Objectives: To investigate adaptive skills, behavior, and quality health-related quality of life in children from 32 centers enrolling in the Heart And Lung Failure-Pediatric INsulin Titration randomized controlled trial.

Study Design: This prospective longitudinal cohort study compared the effect of 2 tight glycemic control ranges (lower target, 80-100 mg/dL vs higher target, 150-180 mg/dL) 1-year neurobehavioral and health-related quality of life outcomes. Subjects had confirmed hyperglycemia and cardiac and/or respiratory failure. Patients aged 2-16 years old enrolled between April 2012 and September 2016 were studied at 1 year after intensive care discharge. The primary outcome, adaptive skills, was assessed using the Vineland Adaptive Behavior Scale. Behavior and health-related quality of life outcomes were assessed as secondary outcomes using the Pediatric Quality of Life and Child Behavior Checklist at baseline and 1-year follow-up. Group differences were evaluated using regression models adjusting for age category, baseline overall performance, and risk of mortality.

Results: Of 369 eligible children, 358 survived after hospital discharge and 214 (60%) completed follow-up. One-year Vineland Adaptive Behavior Scale-II composite scores were not different (mean ± SD, 79.9 ± 25.5 vs 79.4 ± 26.9, lower vs higher target; P = .20). Improvement in Pediatric Quality of Life total health from baseline was greater in the higher target group (adjusted mean difference, 8.2; 95% CI, 1.1-15.3; P = .02).

Conclusions: One-year adaptive behavior in critically ill children with lower vs higher target glycemic control did not differ. The higher target group demonstrated improvement from baseline in overall health. This study affirms the lack of benefit of lower glucose targeting.

Trial Registration: ClinicalTrials.gov: NCT01565941.
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http://dx.doi.org/10.1016/j.jpeds.2019.10.055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7122648PMC
March 2020

A National Approach to Pediatric Sepsis Surveillance.

Pediatrics 2019 12;144(6)

Department of Population Medicine, Harvard Medical School, Harvard University and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.

Pediatric sepsis is a major public health concern, and robust surveillance tools are needed to characterize its incidence, outcomes, and trends. The increasing use of electronic health records (EHRs) in the United States creates an opportunity to conduct reliable, pragmatic, and generalizable population-level surveillance using routinely collected clinical data rather than administrative claims or resource-intensive chart review. In 2015, the US Centers for Disease Control and Prevention recruited sepsis investigators and representatives of key professional societies to develop an approach to adult sepsis surveillance using clinical data recorded in EHRs. This led to the creation of the adult sepsis event definition, which was used to estimate the national burden of sepsis in adults and has been adapted into a tool kit to facilitate widespread implementation by hospitals. In July 2018, the Centers for Disease Control and Prevention convened a new multidisciplinary pediatric working group to tailor an EHR-based national sepsis surveillance approach to infants and children. Here, we describe the challenges specific to pediatric sepsis surveillance, including evolving clinical definitions of sepsis, accommodation of age-dependent physiologic differences, identifying appropriate EHR markers of infection and organ dysfunction among infants and children, and the need to account for children with medical complexity and the growing regionalization of pediatric care. We propose a preliminary pediatric sepsis event surveillance definition and outline next steps for refining and validating these criteria so that they may be used to estimate the national burden of pediatric sepsis and support site-specific surveillance to complement ongoing initiatives to improve sepsis prevention, recognition, and treatment.
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http://dx.doi.org/10.1542/peds.2019-1790DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6889946PMC
December 2019

Outcomes Associated With Multiple Organ Dysfunction Syndrome in Critically Ill Children With Hyperglycemia.

Pediatr Crit Care Med 2019 12;20(12):1147-1156

Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA.

Objectives: Patterns and outcomes of multiple organ dysfunction syndrome are unknown in critically ill children with hyperglycemia. We aimed to determine whether tight glycemic control to a lower vs. higher range influenced timing, duration, or resolution of multiple organ dysfunction syndrome as well as characterize the clinical outcomes of subgroups of multiple organ dysfunction syndrome in children enrolled in the Heart And Lung Failure-Pediatric INsulin Titration trial.

Design: Planned secondary analysis of the multicenter Heart And Lung Failure-Pediatric INsulin Titration trial.

Setting: Thirty-five PICUs.

Patients: Critically ill children with hyperglycemia who received the Heart And Lung Failure-Pediatric INsulin Titration protocol from 2012 to 2016.

Interventions: Randomization to a lower versus higher glucose target group.

Measurements And Main Results: Of 698 patients analyzed, 48 (7%) never developed multiple organ dysfunction syndrome, 549 (79%) had multiple organ dysfunction syndrome without progression, 32 (5%) developed new multiple organ dysfunction syndrome, and 69 (10%) developed progressive multiple organ dysfunction syndrome. Of those whose multiple organ dysfunction syndrome resolved, 192 (34%) experienced recurrent multiple organ dysfunction syndrome. There were no significant differences in the proportion of multiple organ dysfunction syndrome subgroups between Heart And Lung Failure-Pediatric INsulin Titration glucose target groups. However, patients with new or progressive multiple organ dys function syndrome had fewer ICU-free days through day 28 than those without new or progressive multiple organ dysfunction syndrome, and progressive multiple organ dysfunction syndrome patients had fewer ICU-free days than those with new multiple organ dysfunction syndrome: median 25.1 days for never multiple organ dysfunction syndrome, 20.2 days for multiple organ dysfunction syndrome without progression, 18.6 days for new multiple organ dysfunction syndrome, and 0 days for progressive multiple organ dysfunction syndrome (all comparisons p < 0.001). Patients with recurrent multiple organ dysfunction syndrome experienced fewer ICU-free days than those without recurrence (median, 11.2 vs 22.8 d; p < 0.001).

Conclusions: Tight glycemic control target range was not associated with differences in the proportion of new, progressive, or recurrent multiple organ dysfunction syndrome. New or progressive multiple organ dysfunction syndrome was associated with poor clinical outcomes, and progressive multiple organ dysfunction syndrome was associated with worse outcomes than new multiple organ dysfunction syndrome. In future studies, new multiple organ dysfunction syndrome and progressive multiple organ dysfunction syndrome may need to be considered separately, as they represent distinct subgroups with different, potentially modifiable risk factors. Patients with recurrent multiple organ dysfunction syndrome represent a newly characterized, high-risk group which warrants attention in future research.
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http://dx.doi.org/10.1097/PCC.0000000000002151DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6895434PMC
December 2019

When Is Our Job Done? Evaluation of Long-Term Psychological Outcomes in Pediatric Critical Care.

Pediatr Crit Care Med 2019 11;20(11):1099-1100

Division of Pediatric Critical Care Medicine, Department of Pediatrics, Stony Brook University Medical Center, Renaissance School of Medicine, Stony Brook, NY Division of Medical Critical Care, Department of Pediatrics Boston Children's Hospital, Harvard Medical School, Boston, MA.

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http://dx.doi.org/10.1097/PCC.0000000000002093DOI Listing
November 2019

Early Enteral Nutrition Is Associated With Improved Clinical Outcomes in Critically Ill Children: A Secondary Analysis of Nutrition Support in the Heart and Lung Failure-Pediatric Insulin Titration Trial.

Pediatr Crit Care Med 2020 03;21(3):213-221

Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA.

Objectives: The impact of early enteral nutrition on clinical outcomes in critically ill children has not been adequately described. We hypothesized that early enteral nutrition is associated with improved clinical outcomes in critically ill children.

Design: Secondary analysis of the Heart and Lung Failure-Pediatric Insulin Titration randomized controlled trial.

Setting: Thirty-five PICUs.

Patients: Critically ill children with hyperglycemia requiring inotropic support and/or invasive mechanical ventilation who were enrolled for at least 48 hours with complete nutrition data.

Interventions: Subjects received nutrition via guidelines that emphasized enteral nutrition and were classified into early enteral nutrition (enteral nutrition within 48 hr of study randomization) and no early enteral nutrition (enteral nutrition after 48 hr of study randomization, or no enteral nutrition at any time).

Measurements And Main Results: Of 608 eligible subjects, 331 (54%) received early enteral nutrition. Both early enteral nutrition and no early enteral nutrition groups had similar daily caloric intake over the first 8 study days (median, 36 vs 36 kcal/kg/d; p = 0.93). After controlling for age, body mass index z scores, primary reason for ICU admission, severity of illness, and mean Vasopressor-Inotrope Score at the time of randomization, and adjusting for site, early enteral nutrition was associated with lower 90-day hospital mortality (8% vs 17%; p = 0.007), more ICU-free days (median, 20 vs 17 d; p = 0.02), more hospital-free days (median, 8 vs 0 d; p = 0.003), more ventilator-free days (median, 21 vs 19 d; p = 0.003), and less organ dysfunction (median maximum Pediatric Logistic Organ Dysfunction, 11 vs 12; p < 0.001).

Conclusions: In critically ill children with hyperglycemia requiring inotropic support and/or mechanical ventilation, early enteral nutrition was independently associated with better clinical outcomes.
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http://dx.doi.org/10.1097/PCC.0000000000002135DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7060827PMC
March 2020

Executive Summary: Criteria for Critical Care of Infants and Children: PICU Admission, Discharge, and Triage Practice Statement and Levels of Care Guidance.

Pediatrics 2019 10 5;144(4). Epub 2019 Sep 5.

Division of Medical Critical Care, Boston Children's Hospital and Harvard Medical School, Harvard University, Boston, Massachusetts.

This is an executive summary of the 2019 update of the 2004 guidelines and levels of care for PICU. Since previous guidelines, there has been a tremendous transformation of Pediatric Critical Care Medicine with advancements in pediatric cardiovascular medicine, transplant, neurology, trauma, and oncology as well as improvements of care in general PICUs. This has led to the evolution of resources and training in the provision of care through the PICU. Outcome and quality research related to admission, transfer, and discharge criteria as well as literature regarding PICU levels of care to include volume, staffing, and structure were reviewed and included in this statement as appropriate. Consequently, the purposes of this significant update are to address the transformation of the field and codify a revised set of guidelines that will enable hospitals, institutions, and individuals in developing the appropriate PICU for their community needs. The target audiences of the practice statement and guidance are broad and include critical care professionals; pediatricians; pediatric subspecialists; pediatric surgeons; pediatric surgical subspecialists; pediatric imaging physicians; and other members of the patient care team such as nurses, therapists, dieticians, pharmacists, social workers, care coordinators, and hospital administrators who make daily administrative and clinical decisions in all PICU levels of care.
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http://dx.doi.org/10.1542/peds.2019-2433DOI Listing
October 2019

Criteria for Critical Care Infants and Children: PICU Admission, Discharge, and Triage Practice Statement and Levels of Care Guidance.

Pediatr Crit Care Med 2019 09;20(9):847-887

Pediatrics and Pediatric Critical Care Medicine, Department of Pediatrics, Mount Sinai Beth Israel and Mount Sinai West Hospitals, New York City, NY.

Objectives: To update the American Academy of Pediatrics and Society of Critical Care Medicine's 2004 Guidelines and levels of care for PICU.

Design: A task force was appointed by the American College of Critical Care Medicine to follow a standardized and systematic review of the literature using an evidence-based approach. The 2004 Admission, Discharge and Triage Guidelines served as the starting point, and searches in Medline (Ovid), Embase (Ovid), and PubMed resulted in 329 articles published from 2004 to 2016. Only 21 pediatric studies evaluating outcomes related to pediatric level of care, specialized PICU, patient volume, or personnel. Of these, 13 studies were large retrospective registry data analyses, six small single-center studies, and two multicenter survey analyses. Limited high-quality evidence was found, and therefore, a modified Delphi process was used. Liaisons from the American Academy of Pediatrics were included in the panel representing critical care, surgical, and hospital medicine expertise for the development of this practice guidance. The title was amended to "practice statement" and "guidance" because Grading of Recommendations, Assessment, Development, and Evaluation methodology was not possible in this administrative work and to align with requirements put forth by the American Academy of Pediatrics.

Methods: The panel consisted of two groups: a voting group and a writing group. The panel used an iterative collaborative approach to formulate statements on the basis of the literature review and common practice of the pediatric critical care bedside experts and administrators on the task force. Statements were then formulated and presented via an online anonymous voting tool to a voting group using a three-cycle interactive forecasting Delphi method. With each cycle of voting, statements were refined on the basis of votes received and on comments. Voting was conducted between the months of January 2017 and March 2017. The consensus was deemed achieved once 80% or higher scores from the voting group were recorded on any given statement or where there was consensus upon review of comments provided by voters. The Voting Panel was required to vote in all three forecasting events for the final evaluation of the data and inclusion in this work. The writing panel developed admission recommendations by level of care on the basis of voting results.

Results: The panel voted on 30 statements, five of which were multicomponent statements addressing characteristics specific to PICU level of care including team structure, technology, education and training, academic pursuits, and indications for transfer to tertiary or quaternary PICU. Of the remaining 25 statements, 17 reached consensus cutoff score. Following a review of the Delphi results and consensus, the recommendations were written.

Conclusions: This practice statement and level of care guidance manuscript addresses important specifications for each PICU level of care, including the team structure and resources, technology and equipment, education and training, quality metrics, admission and discharge criteria, and indications for transfer to a higher level of care. The sparse high-quality evidence led the panel to use a modified Delphi process to seek expert opinion to develop consensus-based recommendations where gaps in the evidence exist. Despite this limitation, the members of the Task Force believe that these recommendations will provide guidance to practitioners in making informed decisions regarding pediatric admission or transfer to the appropriate level of care to achieve best outcomes.
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http://dx.doi.org/10.1097/PCC.0000000000001963DOI Listing
September 2019

Short-Term Adverse Outcomes Associated With Hypoglycemia in Critically Ill Children.

Crit Care Med 2019 05;47(5):706-714

Division of Medical Critical Care, Department of Pediatrics, Boston Children's Hospital, Boston, MA.

Objectives: Previous studies report worse short-term outcomes with hypoglycemia in critically ill children. These studies relied on intermittent blood glucose measurements, which may have introduced detection bias. We analyzed data from the Heart And Lung Failure-Pediatric INsulin Titration trial to determine the association of hypoglycemia with adverse short-term outcomes in critically ill children.

Design: Nested case-control study.

Setting: Thirty-five PICUs. A computerized algorithm that guided the timing of blood glucose measurements and titration of insulin infusion, continuous glucose monitors, and standardized glucose infusion rates were used to minimize hypoglycemia.

Patients: Nondiabetic children with cardiovascular and/or respiratory failure and hyperglycemia. Cases were children with any hypoglycemia (blood glucose < 60 mg/dL), whereas controls were children without hypoglycemia. Each case was matched with up to four unique controls according to age group, study day, and severity of illness.

Interventions: None.

Measurements And Main Results: A total of 112 (16.0%) of 698 children who received the Heart And Lung Failure-Pediatric INsulin Titration protocol developed hypoglycemia, including 25 (3.6%) who developed severe hypoglycemia (blood glucose < 40 mg/dL). Of these, 110 cases were matched to 427 controls. Hypoglycemia was associated with fewer ICU-free days (median, 15.3 vs 20.2 d; p = 0.04) and fewer hospital-free days (0 vs 7 d; p = 0.01) through day 28. Ventilator-free days through day 28 and mortality at 28 and 90 days did not differ between groups. More children with insulin-induced versus noninsulin-induced hypoglycemia had zero ICU-free days (35.8% vs 20.9%; p = 0.008). Outcomes did not differ between children with severe versus nonsevere hypoglycemia or those with recurrent versus isolated hypoglycemia.

Conclusions: When a computerized algorithm, continuous glucose monitors and standardized glucose infusion rates were used to manage hyperglycemia in critically ill children with cardiovascular and/or respiratory failure, severe hypoglycemia (blood glucose < 40 mg/dL) was uncommon, but any hypoglycemia (blood glucose < 60 mg/dL) remained common and was associated with worse short-term outcomes.
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May 2019

Adjusting Insulin Delivery to Activity (AIDA) clinical trial: Effects of activity-based insulin profiles on glucose control in children with type 1 diabetes.

Pediatr Diabetes 2018 12 9;19(8):1451-1458. Epub 2018 Sep 9.

Medicine Critical Care, Department of Medicine, Boston Children's Hospital, Boston, Massachusetts.

Background: Increased daytime activity in children with type I diabetes mellitus (T1DM) is associated with increased risk of hypoglycemia.

Objective: To determine whether an automated weekly review of accelerometer, continuous glucose monitoring (CGM), and insulin pump data, could be used to identify children with increased risk of nighttime hypoglycemia and preemptively adjust the nighttime basal insulin profile according to daytime activity.

Research And Design Methods: Clinical trial of children with T1DM on insulin pump and CGM therapy. Subjects at risk of nighttime hypoglycemia were identified from regression analysis of daytime step count vs nighttime nadir glucose. If the regression slope was significantly different from zero (P < 0.05) subjects were managed with different algorithm derived nighttime basal insulin profiles following high and low activity days.

Results: Twenty children (median age: 12; range: 7-17 years) were enrolled. Regression slopes were significant in 10 children. In these children, baseline nighttime nadir glucose level was lower following high activity days (120 [110-139] vs 152 [130-162] mg/dL, P = 0.004). Use of activity-based nighttime basal profiles produced similar nighttime nadir glucose levels following high and low activity days (136 [123-175] vs 140 [108-180] mg/dL, P = 0.73) with fewer nighttime interventions to correct hypoglycemia (0 [0-0.16] vs 0.15 [0.13-0.22] per night, P = 0.008).

Conclusion: Children with lower nighttime glucose levels following high daytime activity can be identified using step count data obtained from readily available accelerometers and the nighttime glucose control improved using different activity-based basal profiles.
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http://dx.doi.org/10.1111/pedi.12752DOI Listing
December 2018

Beyond Survival: Pediatric Critical Care Interventional Trial Outcome Measure Preferences of Families and Healthcare Professionals.

Pediatr Crit Care Med 2018 02;19(2):e105-e111

Division of Pediatric Critical Care Medicine, Department of Pediatrics, Seattle Children's Hospital, University of Washington, School of Medicine, Seattle, WA.

Objectives: To identify, in addition to survival, preferred outcome measures of PICU family care providers and PICU healthcare professionals for interventional trials enrolling critically ill children, and to describe general attitudes of family care providers and healthcare professionals regarding research in the PICU.

Design: Cross-sectional survey examining subject experience with clinical research and personal preferences for outcome measures for a hypothetical interventional clinical trial.

Setting: PICUs within four academic children's hospitals in the United States and Canada.

Subjects: Two cohorts including family members of critically ill children in PICUs (family care providers) and multidisciplinary staff working in the PICUs (healthcare professionals).

Interventions: Administration of a short, deidentified survey.

Measurements: Demographic data were collated for the two subject groups. Participants were queried regarding their attitudes related to research conducted in the PICU. In addition to survival, each group was asked to identify their three most important outcomes for an investigation examining whether or not an intervention helps seriously ill children recover.

Main Results: Demographics for family care providers (n = 40) and healthcare professionals (n = 53) were similarly distributed. Female respondents (79.8%) predominated. Participants (98.9%) ascertained the importance of conducting research in the PICU, but significant challenges associated with this goal in the high stress PICU environment. Both quality of life and functioning after leaving the hospital were chosen as the most preferred outcome measure, with 77.5% of family care providers and 84.9% of healthcare professionals indicating this choice. Duration of organ dysfunction was identified by 70.0% of family care providers and 40.7% of healthcare professionals as the second most preferred outcome measure.

Conclusions: In addition to survival, long-term quality of life/functional status and duration of organ dysfunction represent important interventional trial outcome measures for both families of critically ill children, as well as the multidisciplinary team who provides critical care.
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February 2018

Glucocorticoid Equipoise.

Crit Care Med 2018 04;46(4):493

Harvard Medical School; and Division of Medicine Critical Care, Boston Children's Hospital, Boston, MA Stony Brook University School of Medicine; and Division of Critical Care, Stony Brook Children's Hospital, Stony Brook, NY.

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April 2018

The authors reply.

Pediatr Crit Care Med 2017 12;18(12):1191

Division of Cardiac Critical Care, Department of Anesthesia/Critical Care Medicine, Children's Hospital of Philadelphia, Perelman School of Medicine, Philadelphia, PA; Division of Critical Care, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA; Division of Nephrology, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA.

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http://dx.doi.org/10.1097/PCC.0000000000001366DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5764111PMC
December 2017

Pediatric intermediate care and pediatric intensive care units: PICU metrics and an analysis of patients that use both.

J Crit Care 2017 10 26;41:268-274. Epub 2017 May 26.

Division of Pediatric Critical Care Medicine, Department of Pediatrics, Columbia University College of Physicians and Surgeons, Morgan Stanley Children's Hospital, 3959 Broadway, New York, NY 10032, United States. Electronic address:

Purpose: To examine how intermediate care units (IMCUs) are used in relation to pediatric intensive care units (PICUs), characterize PICU patients that utilize IMCUs, and estimate the impact of IMCUs on PICU metrics.

Materials & Methods: Retrospective study of PICU patients discharged from 108 hospitals from 2009 to 2011. Patients admitted from or discharged to IMCUs were characterized. We explored the relationships between having an IMCU and several PICU metrics: physical length-of-stay (LOS), medical LOS, discharge wait time, admission severity of illness, unplanned PICU admissions from wards, and early PICU readmissions.

Results: Thirty-three percent of sites had an IMCU. After adjusting for known confounders, there was no association between having an IMCU and PICU LOS, mean severity of illness of PICU patients admitted from general wards, or proportion of PICU readmissions or unplanned ward admissions. At sites with an IMCU, patients waited 3.1h longer for transfer from the PICU once medically cleared (p<0.001).

Conclusions: There was no association between having an IMCU and most measures of PICU efficiency. At hospitals with an IMCU, patients spent more time in the PICU once they were cleared for discharge. Other ways that IMCUs might affect PICU efficiency or particular patient populations should be investigated.
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http://dx.doi.org/10.1016/j.jcrc.2017.05.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5633493PMC
October 2017

Tight Glycemic Control in Critically Ill Children.

N Engl J Med 2017 06;376(23):e48

University of Pennsylvania Perelman School of Medicine, Philadelphia, PA

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http://dx.doi.org/10.1056/NEJMc1703642DOI Listing
June 2017

Acute Kidney Injury After Pediatric Cardiac Surgery: A Secondary Analysis of the Safe Pediatric Euglycemia After Cardiac Surgery Trial.

Pediatr Crit Care Med 2017 Jul;18(7):638-646

1Division of Cardiac Critical Care, Department of Anesthesia/Critical Care, Children's Hospital of Philadelphia, Perelman School of Medicine, Philadelphia, PA. 2Department of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA. 3Division of Critical Care Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA. 4Department of Pediatrics, University of Michigan Medical School, C.S. Mott Children's Hospital, Ann Arbor, MI. 5Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA.

Objectives: To understand the effect of tight glycemic control on cardiac surgery-associated acute kidney injury.

Design: Secondary analysis of data from the Safe Pediatric Euglycemia after Cardiac Surgery trial of tight glycemic control versus standard care.

Setting: Pediatric cardiac ICUs at University of Michigan, C.S. Mott Children's Hospital, and Boston Children's Hospital.

Patients: Children 0-36 months old undergoing congenital cardiac surgery.

Interventions: None.

Measurements And Main Results: Cardiac surgery-associated acute kidney injury was assigned using the Acute Kidney Injury Network criteria with the modification that a greater than 0.1 mg/dL increase in serum creatinine was required to assign cardiac surgery-associated acute kidney injury. We explored associations between cardiac surgery-associated acute kidney injury and tight glycemic control and clinical outcomes. Of 799 patients studied, cardiac surgery-associated acute kidney injury occurred in 289 patients (36%), most of whom had stage II or III disease (72%). Cardiac surgery-associated acute kidney injury rates were similar between treatment groups (36% vs 36%; p = 0.99). Multivariable modeling showed that patients with cardiac surgery-associated acute kidney injury were younger (p = 0.002), underwent more complex surgery (p = 0.005), and had longer cardiopulmonary bypass times (p = 0.002). Cardiac surgery-associated acute kidney injury was associated with longer mechanical ventilation and ICU and hospital stays and increased mortality. Patients at University of Michigan had higher rates of cardiac surgery-associated acute kidney injury compared with Boston Children's Hospital patients (66% vs 15%; p < 0.001), but University of Michigan patients with cardiac surgery-associated acute kidney injury had shorter time to extubation and ICU and hospital stays compared with Boston Children's Hospital patients.

Conclusions: Tight glycemic control did not reduce the cardiac surgery-associated acute kidney injury rate in this trial cohort. We observed significant differences in cardiac surgery-associated acute kidney injury rates between the two study sites, and there was a differential effect of cardiac surgery-associated acute kidney injury on clinical outcomes by site. These findings warrant further investigation to identify causal variation in perioperative practices that affect cardiac surgery-associated acute kidney injury epidemiology.
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http://dx.doi.org/10.1097/PCC.0000000000001185DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5503840PMC
July 2017

Tight Glycemic Control in Critically Ill Children.

N Engl J Med 2017 02 24;376(8):729-741. Epub 2017 Jan 24.

From the Division of Medicine Critical Care (M.S.D.A., J.L.A., G.M.S.) and the Department of Cardiology (D.W., L.A.A.), Boston Children's Hospital and Harvard Medical School, Boston; the Division of Pediatric Critical Care, University of Utah Medical School, Primary Children's Hospital, Salt Lake City, and Intermountain Medical Center, Murray - both in Utah (E.L.H.); Children's Hospital of Philadelphia (V.S., V.M.N.) and the Perelman School of Medicine (V.S., M.A.Q.C., V.M.N.) and the School of Nursing (M.A.Q.C.), University of Pennsylvania - all in Philadelphia; Yale School of Medicine, New Haven, CT (E.V.F.); and Children's Medical Center Dallas and the University of Texas Southwestern Medical School, Dallas (P.M.L.).

Background: In multicenter studies, tight glycemic control targeting a normal blood glucose level has not been shown to improve outcomes in critically ill adults or children after cardiac surgery. Studies involving critically ill children who have not undergone cardiac surgery are lacking.

Methods: In a 35-center trial, we randomly assigned critically ill children with confirmed hyperglycemia (excluding patients who had undergone cardiac surgery) to one of two ranges of glycemic control: 80 to 110 mg per deciliter (4.4 to 6.1 mmol per liter; lower-target group) or 150 to 180 mg per deciliter (8.3 to 10.0 mmol per liter; higher-target group). Clinicians were guided by continuous glucose monitoring and explicit methods for insulin adjustment. The primary outcome was the number of intensive care unit (ICU)-free days to day 28.

Results: The trial was stopped early, on the recommendation of the data and safety monitoring board, owing to a low likelihood of benefit and evidence of the possibility of harm. Of 713 patients, 360 were randomly assigned to the lower-target group and 353 to the higher-target group. In the intention-to-treat analysis, the median number of ICU-free days did not differ significantly between the lower-target group and the higher-target group (19.4 days [interquartile range {IQR}, 0 to 24.2] and 19.4 days [IQR, 6.7 to 23.9], respectively; P=0.58). In per-protocol analyses, the median time-weighted average glucose level was significantly lower in the lower-target group (109 mg per deciliter [IQR, 102 to 118]; 6.1 mmol per liter [IQR, 5.7 to 6.6]) than in the higher-target group (123 mg per deciliter [IQR, 108 to 142]; 6.8 mmol per liter [IQR, 6.0 to 7.9]; P<0.001). Patients in the lower-target group also had higher rates of health care-associated infections than those in the higher-target group (12 of 349 patients [3.4%] vs. 4 of 349 [1.1%], P=0.04), as well as higher rates of severe hypoglycemia, defined as a blood glucose level below 40 mg per deciliter (2.2 mmol per liter) (18 patients [5.2%] vs. 7 [2.0%], P=0.03). No significant differences were observed in mortality, severity of organ dysfunction, or the number of ventilator-free days.

Conclusions: Critically ill children with hyperglycemia did not benefit from tight glycemic control targeted to a blood glucose level of 80 to 110 mg per deciliter, as compared with a level of 150 to 180 mg per deciliter. (Funded by the National Heart, Lung, and Blood Institute and others; HALF-PINT ClinicalTrials.gov number, NCT01565941 .).
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http://dx.doi.org/10.1056/NEJMoa1612348DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5444653PMC
February 2017