Strict Glucose Control of Pediatric Intensive Care Unit (ICU) Patients
Not Applicable
Withdrawn
- Conditions
- Respiratory FailureSepsisCardiovascular FailureTrauma
- Registration Number
- NCT00247468
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief Summary
The study objective is to improve morbidity and mortality of high-risk critically ill children. Our hypothesis is that a strict ICU glucose control protocol will decrease morbidity and mortality associated with hyperglycemia in a population of high-risk critically ill pediatric patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Vasoactive infusion (e.g. dopamine, epinephrine, norepinephrine) and/or
- Invasive mechanical ventilation
- Age between 1 mo and 21 yrs
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Exclusion Criteria
- Type I diabetes mellitus
- Have an illness that requires insulin daily
- Recipients of solid organ transplants
- Participation in an experimental trial that might affect outcome
- Post-operative patients with planned extubation upon recovery
- Patients on a dopamine infusion of less than 3 mcg/kg/minute
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 30-day mortality rate from the time of enrollment
- Secondary Outcome Measures
Name Time Method Pediatric Overall Performance Category scores at ICU discharge and 6 months post-discharge rates of nosocomial bloodstream infections time to resolution of organ failure (mechanical ventilator days and days of vasopressor support) change in Pediatric Logistic Organ Dysfunction scores requirement of dialysis or hemofiltration for patients with acute renal failure volume of blood product transfusions per kilogram body weight (vol/kg).