Heart And Lung Failure - Pediatric INsulin Titration Trial

Completed · Phase 3

Conditions studied: Heart Failure, Respiratory Failure

In brief

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.

Key facts

Study ID

NCT01565941

Run by

Boston Children's Hospital

People needed

713

Starts

2012-04-01

Expected to finish

2018-02-01

Last updated by the study team

2022-07-25

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cardiovascular failure and/or respiratory failure:
• Cardiovascular Failure: Dopamine or dobutamine > 5 mcg/kg/min, or any dose of epinephrine, norepinephrine, phenylephrine, milrinone or vasopressin if used to treat hypotension.
• Respiratory Failure: Acute mechanical ventilation via endotracheal tube or tracheostomy.
• Age >= 2 weeks and corrected gestational age >= 42 weeks
• Age < 18 years (has not yet had 18th birthday)

You may not qualify if…

• 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 (extra-corporeal life support or non-cardiac surgery is acceptable)
• 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

Where it is running

• Miller Children's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital of Los Angelos — Los Angeles, California, United States
• Mattel Children's Hospital — Los Angeles, California, United States
• Children's Hospital & Research Center of Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• UCSF Benioff Children's Hospital — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Yale-New Haven Children's Hospital — New Haven, Connecticut, United States
• Nemours/A.I DuPont Hospital for Children — Wilmington, Delaware, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital pf Chicago — Chicago, Illinois, United States
• University of Chicago Comer Children's Hospital — Chicago, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Women and Children's Hospital of Buffalo — Buffalo, New York, United States
• North Shore LIJ Cohen Children's Medical Center — New Hyde Park, New York, United States
• Morgan Stanley Children's Hospital of New York — New York, New York, United States
• The Children's Hospital at Montefiore — The Bronx, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• Duke Children's Hospital and Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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