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Heart And Lung Failure - Pediatric INsulin Titration Trial
NCT01565941 · View on ClinicalTrials.gov ↗
Study 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 490 critically ill infants and children.
Conditions Studied
Interventions
- DRUG Insulin
Study Locations (20)
California
- Miller Children's Hospital Long Beach — Long Beach
- Children's Hospital of Los Angelos — Los Angeles
- Mattel Children's Hospital — Los Angeles
- Children's Hospital & Research Center of Oakland — Oakland
- Children's Hospital of Orange County — Orange
- UCSF Benioff Children's Hospital — San Francisco
Illinois
- Ann & Robert H. Lurie Children's Hospital pf Chicago — Chicago
- University of Chicago Comer Children's Hospital — Chicago
Maryland
- University of Maryland Medical Center — Baltimore
- Johns Hopkins Hospital — Baltimore
Colorado
- Children's Hospital Colorado — Aurora
Connecticut
- Yale-New Haven Children's Hospital — New Haven
Delaware
- Nemours/A.I DuPont Hospital for Children — Wilmington
Georgia
- Children's Healthcare of Atlanta — Atlanta
Kentucky
- University of Louisville — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 713 participants |
| Start Date | 2012-04 |
| Est. Completion | 2018-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01565941
The ClinicalTrials.gov registry entry for NCT01565941 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 713 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 752 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which Insulin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01565941 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Illinois, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01565941 about?
NCT01565941 is a clinical study titled "Heart And Lung Failure - Pediatric INsulin Titration Trial". 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 pa...
What is the current status of trial NCT01565941?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 713 participants. The study started on 2012-04. Estimated completion is 2018-02.
What conditions does trial NCT01565941 study?
This clinical trial studies the following conditions: Heart Failure, Respiratory Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01565941?
The interventions under investigation include: Insulin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01565941?
This trial is sponsored by Boston Children's Hospital, which has 752 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01565941 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Delaware, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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