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 journalArticle

1 Citation (Scopus)

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

Fingerprint

Critical Illness
Randomized Controlled Trials
Heart Failure
Insulin
Pediatrics
Lung
Hospital Mortality
Glucose
Length of Stay
Organ Dysfunction Scores
Mechanical Ventilators
Patient Safety
Cross Infection
Workload
Artificial Respiration
Hypoglycemia
Respiratory Insufficiency
Hyperglycemia
Blood Glucose
Decision Making

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)

Cite this

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. / Agus, Michael SD; Hirshberg, Ellie; Srinivasan, Vijay; Faustino, Edward Vincent; Luckett, Peter M.; Curley, Martha AQ; Alexander, Jamin; Asaro, Lisa A.; Coughlin-Wells, Kerry; Duva, Donna; French, Jaclyn; Hasbani, Natalie; Sisko, Martha T.; Soto-Rivera, Carmen L.; Steil, Garry; Wypij, David; Nadkarni, Vinay M.

In: Contemporary Clinical Trials, Vol. 53, 01.02.2017, p. 178-187.

Research output: Contribution to journalArticle

Agus, MSD, Hirshberg, E, Srinivasan, V, Faustino, EV, Luckett, PM, Curley, MAQ, Alexander, J, Asaro, LA, Coughlin-Wells, K, Duva, D, French, J, Hasbani, N, Sisko, MT, Soto-Rivera, CL, Steil, G, Wypij, D & Nadkarni, VM 2017, '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', Contemporary Clinical Trials, vol. 53, pp. 178-187. https://doi.org/10.1016/j.cct.2016.12.023
Agus, Michael SD ; Hirshberg, Ellie ; Srinivasan, Vijay ; Faustino, Edward Vincent ; Luckett, Peter M. ; Curley, Martha AQ ; Alexander, Jamin ; Asaro, Lisa A. ; Coughlin-Wells, Kerry ; Duva, Donna ; French, Jaclyn ; Hasbani, Natalie ; Sisko, Martha T. ; Soto-Rivera, Carmen L. ; Steil, Garry ; Wypij, David ; Nadkarni, Vinay M. / 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. In: Contemporary Clinical Trials. 2017 ; Vol. 53. pp. 178-187.
@article{76c20a77edfb4f02992894271d9f0b59,
title = "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",
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.",
keywords = "Insulin therapy, Pediatric critical care, Randomized clinical trial, Stress hyperglycemia",
author = "Agus, {Michael SD} and Ellie Hirshberg and Vijay Srinivasan and Faustino, {Edward Vincent} and Luckett, {Peter M.} and Curley, {Martha AQ} and Jamin Alexander and Asaro, {Lisa A.} and Kerry Coughlin-Wells and Donna Duva and Jaclyn French and Natalie Hasbani and Sisko, {Martha T.} and Soto-Rivera, {Carmen L.} and Garry Steil and David Wypij and Nadkarni, {Vinay M.}",
year = "2017",
month = "2",
day = "1",
doi = "10.1016/j.cct.2016.12.023",
language = "English (US)",
volume = "53",
pages = "178--187",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Design and rationale of Heart and Lung Failure – Pediatric INsulin Titration Trial (HALF-PINT)

T2 - A randomized clinical trial of tight glycemic control in hyperglycemic critically ill children

AU - Agus, Michael SD

AU - Hirshberg, Ellie

AU - Srinivasan, Vijay

AU - Faustino, Edward Vincent

AU - Luckett, Peter M.

AU - Curley, Martha AQ

AU - Alexander, Jamin

AU - Asaro, Lisa A.

AU - Coughlin-Wells, Kerry

AU - Duva, Donna

AU - French, Jaclyn

AU - Hasbani, Natalie

AU - Sisko, Martha T.

AU - Soto-Rivera, Carmen L.

AU - Steil, Garry

AU - Wypij, David

AU - Nadkarni, Vinay M.

PY - 2017/2/1

Y1 - 2017/2/1

N2 - 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.

AB - 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.

KW - Insulin therapy

KW - Pediatric critical care

KW - Randomized clinical trial

KW - Stress hyperglycemia

UR - http://www.scopus.com/inward/record.url?scp=85008319025&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85008319025&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2016.12.023

DO - 10.1016/j.cct.2016.12.023

M3 - Article

VL - 53

SP - 178

EP - 187

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

ER -