Design and rationale of Heart and Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT): A randomized clinical trial of tight glycemic control in hyperglycemic critically ill children

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• 作者：Michael SD Agus^a ; ^{michael.agus@childrens.harvard.edu} ; Ellie Hirshberg^b ; ^{ellie.hirshberg@hsc.utah.edu} ; Vijay Srinivasan^c ; ^{srinivasan@email.chop.edu} ; Edward Vincent Faustino^d ; ^{vince.faustino@yale.edu} ; Peter M Luckett^e ; ^{peter.luckett@childrens.com} ; Martha AQ Curley^f ; ^{curley@nursing.upenn.edu} ; Jamin Alexander^a ; ^{jamin.alexander@childrens.harvard.edu} ; Lisa A Asaro^g ; ^{lisa.asaro@cardio.chboston.org} ; Kerry Coughlin-Wells^a ; ^{kerry.coughlin-wells@childrens.harvard.edu} ; Donna Duva^g ; ^{donna.duva@cardio.chboston.org} ; Jaclyn French^a ; ^{jaclyn.french@childrens.harvard.edu} ; Natalie Hasbani^g ; ^{natalie.hasbani@childrens.harvard.edu} ; Martha T Sisko^c ; ^{siskom@email.chop.edu} ; Carmen L Soto-Rivera^a ; ^{carmen.soto@childrens.harvard.edu} ; Garry Steil^a ; ^{garry.steil@childrens.harvard.edu} ; David Wypij^g ; ^{david.wypij@cardio.chboston.org} ; Vinay M Nadkarni^c ; ^{nadkarni@email.chop.edu}
• 关键词：BG ; blood glucose ; CBCL ; Child Behavior Checklist ; CCC ; Clinical Coordinating Center ; CGM ; continuous glucose monitor ; CHECKS ; Children's Hospital EuglyCemia for Kids Spreadsheet ; CHiP ; Control of Hyperglycaemia in Paediatric intensive care ; DCC ; Data Coordinating Center ; DSMB ; Data and Safety Monitoring Board ; FDA ; Food and Drug Administration ; ICU ; Intensive Care Unit ; IRB ; Institutional Review Board ; LOS ; length of stay ; NASA-TLX ; National Aeronautics and Space Administration-Task Load Index
• 刊名：Contemporary Clinical Trials
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：53
• 期：Complete
• 页码：178-187
• 全文大小：755 K
• 卷排序：53

文摘

Test whether hyperglycemic critically ill children with cardiovascular and/or respiratory failure experience more ICU-free days when assigned to tight glycemic control with a normoglycemic versus hyperglycemic blood glucose target range.DesignMulti-center randomized clinical trial.SettingPediatric ICUs at 35 academic hospitals.PatientsChildren aged 2 weeks to 17 years receiving inotropic support and/or acute mechanical ventilation, excluding cardiac surgical patients.InterventionsPatients receive intravenous insulin titrated to either 80–110 mg/dL (4.4–6.1 mmol/L) or 150–180 mg/dL (8.3–10.0 mmol/L). The intervention begins upon confirmed hyperglycemia and ends when the patient meets study-defined ICU discharge criteria or after 28 days. Continuous glucose monitoring, a minimum glucose infusion, and an explicit insulin infusion algorithm are deployed to achieve the BG targets while minimizing hypoglycemia risk.Measurements and main resultsThe primary outcome is ICU-free days (equivalent to 28-day hospital mortality-adjusted ICU length of stay). Secondary outcomes include 90-day hospital mortality, organ dysfunction scores, ventilator-free days, nosocomial infection rate, neurodevelopmental outcomes, and nursing workload. To detect an increase of 1.25 ICU-free days (corresponding to a 20% relative reduction in 28-day hospital mortality and a one-day reduction in ICU length of stay), 1414 patients are needed for 80% power using a two-sided 0.05 level test.ConclusionsThis trial tests whether hyperglycemic critically ill children randomized to 80–110 mg/dL benefit more than those randomized to 150–180 mg/dL. This study implements validated bedside support tools including continuous glucose monitoring and a computerized algorithm to enhance patient safety and ensure reproducible bedside decision-making in achieving glycemic control.