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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

Year: 2016
Type: article
Abstract: OBJECTIVES: 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. DESIGN: Multi-center randomized clinical trial. SETTING: Pediatric ICUs at 35 academic hospitals. PATIENTS: Children aged 2weeks to 17years receiving inotropic support and/or acute mechanical ventilation, excluding cardiac surgical patients. INTERVENTIONS: Patients receive intravenous insulin titrated to either 80-110mg/dL (4.4-6.1mmol/L) or 150-180mg/dL (8.3-10.0mmol/L). The intervention begins upon confirmed hyperglycemia and ends when the patient meets study-defined ICU discharge criteria or after 28days. 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 RESULTS: The 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. CONCLUSIONS: This trial tests whether hyperglycemic critically ill children randomized to 80-110mg/dL benefit more than those randomized to 150-180mg/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.
DOI: 10.1016/j.cct.2016.12.023
Authors: Michael SD Agus, Ellie Hirshberg, Vijay Srinivasan, Edward Vincent Faustino, Peter M Luckett, Martha AQ Curley, Jamin Alexander, Lisa A Asaro, Kerry Coughlin-Wells, Donna Duva, Jaclyn French, Natalie Hasbani, Martha T Sisko, Carmen L Soto-Rivera, Garry Steil, David Wypij, Vinay M Nadkarni
Institutions: Boston Children's Hospital, Harvard University, University of Utah, Intermountain Medical Center, Children's Hospital of Philadelphia, University of Pennsylvania, Yale University, Children's Medical Center, The University of Texas Southwestern Medical Center
Language: English
Field: Medicine
Open Access status: hybrid
Estimated APC paid: $3,140
Funders: National Aeronautics and Space Administration, Yale University, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, Edwards Lifesciences, University of Pennsylvania, Cincinnati Children's Hospital Medical Center, Children's Hospital Colorado, Johns Hopkins University, Dartmouth College, Pennsylvania State University, Seattle Children's Research Institute, Children's Healthcare of Atlanta, Dexcom, Centre hospitalier universitaire Sainte-Justine, National Institutes of Health, University of California, San Francisco, Penn State Health Children's Hospital, National Heart, Lung, and Blood Institute
OpenAlex ID: W2565093256
FWCI: 2.007
Cites: 53
Cited by: 20
Related to: 10