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
Contemporary Clinical Trials 2017, 53: 178-187

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.

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