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

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

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

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 2 weeks to 17 years receiving inotropic support and/or acute mechanical ventilation, excluding cardiac surgical patients. Interventions Patients 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 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 80–110 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.

Original languageEnglish (US)
Pages (from-to)178-187
Number of pages10
JournalContemporary Clinical Trials
Volume53
DOIs
StatePublished - Feb 1 2017

Keywords

  • Insulin therapy
  • Pediatric critical care
  • Randomized clinical trial
  • Stress hyperglycemia

ASJC Scopus subject areas

  • Pharmacology (medical)

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