Heart And Lung Failure - Pediatric INsulin Titration Trial

  • Interventional
  • Not Recruiting
  • NCT01565941
Eligibility Details Visit Clinicaltrials.gov

Heart And Lung Failure - Pediatric INsulin Titration Trial (HALF-PINT)

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.

Gender
All

Age Group
17 Years and under

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Cardiovascular failure and/or respiratory failure:

             1. Cardiovascular Failure: Dopamine or dobutamine > 5 mcg/kg/min, or any dose of epinephrine, norepinephrine, phenylephrine, milrinone or vasopressin if used to treat hypotension.

             2. 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)

        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 (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

At a Glance

National Government IDNCT01565941

IRB#IRB13-1213

Lead SponsorBoston Children’s Hospital

Lead PhysicianNeethi Pinto

Collaborator(s)N/A

EligibilityAll
17 Years and under
Not Recruiting