Overview

This trial is active, not recruiting.

Conditions heart failure, respiratory failure
Treatments insulin
Phase phase 3
Sponsor Boston Children’s Hospital
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date March 2012
End date July 2018
Trial size 1414 participants
Trial identifier NCT01565941, IRB-P00002310, U01HL107681

Summary

Stress hyperglycemia, a state of abnormal metabolism with supra-normal blood glucose levels, is often seen in critically ill patients. Tight glycemic control (TGC) was originally shown to reduce morbidity and mortality in a landmark randomized clinical trial (RCT) of adult critically ill surgical patients but has since come under intense scrutiny due to conflicting results in recent adult trials. One pediatric RCT has been published to date that demonstrated survival benefit but was complicated by an unacceptably high rate of severe hypoglycemia. The Heart And Lung Failure - Pediatric INsulin Titration (HALF-PINT) trial is a multi-center, randomized clinical treatment trial comparing two ranges of glucose control in hyperglycemic critically ill children with heart and/or lung failure. Both target ranges of glucose control fall within the range of "usual care" for critically ill children managed in pediatric intensive care units.

The purpose of the study is to determine the comparative effectiveness of tight glycemic control to a target range of 80-110 mg/dL (TGC-1, 4.4-6.1 mmol/L) vs. a target range of 150-180 mg/dL (TGC-2, 8.3-10.0 mmol/L) on hospital mortality and intensive care unit (ICU) length of stay (LOS) in hyperglycemic critically ill children with cardiovascular and/or respiratory failure. This will be accomplished using an explicit insulin titration algorithm and continuous glucose monitoring to safely achieve these glucose targets. Both groups will receive identical standardized intravenous glucose at an age-appropriate rate in order to provide basal calories and mitigate hypoglycemia. Insulin infusions will be titrated with an explicit algorithm combined with continuous glucose monitoring using a protocol that has been safely implemented in >900 critically ill infants and children.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.
insulin
IV insulin titration to target a blood glucose of 80-110 mg/dL
(Active Comparator)
Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.
insulin
IV insulin titration to target a blood glucose of 150-180 mg/dL

Primary Outcomes

Measure
ICU-Free Days
time frame: Study day 28

Secondary Outcomes

Measure
90-day Hospital Mortality
time frame: 90 days after randomization
Accumulation of Multiple Organ Dysfunction Syndrome (MODS)
time frame: 28 days after randomization
Ventilator-Free Days
time frame: 28 days following randomization
Incidence of Nosocomial Infections
time frame: Up to 48 hours after ICU discharge
Insulin Algorithm Safety
time frame: Participants will be followed for the duration of ICU stay, an expected average of 8 days
Developmental Neurobehavioral Outcomes
time frame: Baseline and 1 year after ICU course
Nursing Workload
time frame: Multiple intervals during the study period.

Eligibility Criteria

Male or female participants up to 17 years old.

Inclusion Criteria: - Cardiovascular failure and/or respiratory failure: 1. Cardiovascular Failure: Dopamine or dobutamine > 5 mcg/kg/min, or any dose of epinephrine, norepinephrine, milrinone or vasopressin if used to treat hypotension. 2. Respiratory Failure: Acute mechanical ventilation via endotracheal tube or tracheostomy. - Age >= 2 wks and corrected gestational age >= 42 weeks - Age < 18 years (has not yet had 18th birthday) Exclusion Criteria: - No longer has cardiovascular or respiratory failure (as defined in inclusion criterion 1), or is expected to be extubated in the next 24 hours - Expected to remain in ICU < 24 hours - Previously randomized in HALF-PINT - Enrolled in a competing clinical trial - Family/team decision to limit/redirect from aggressive ICU technological support - Chronic ventilator dependence prior to ICU admission (non-invasive ventilation and ventilation via tracheostomy overnight or during sleep are acceptable) - Type 1 or 2 diabetes - Cardiac surgery within prior 2 months or during/planned for this hospitalization - Diffuse skin disease that does not allow securement of a subcutaneous sensor - Therapeutic plan to remain intubated for >28 days - Receiving therapeutic cooling with targeted body temperatures <34 degrees Celsius - Current or planned ketogenic diet - Ward of the state - Pregnancy

Additional Information

Official title Heart And Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT)
Principal investigator Michael SD Agus, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boston Children’s Hospital.