NCT00247468
Withdrawn
Not Applicable
Strict Glucose Control of Pediatric ICU Patients to Reduce Mortality and Morbidity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Failure
- Sponsor
- Children's Hospital of Philadelphia
- Primary Endpoint
- 30-day mortality rate from the time of enrollment
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Vasoactive infusion (e.g. dopamine, epinephrine, norepinephrine) and/or
- •Invasive mechanical ventilation
- •Age between 1 mo and 21 yrs
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
Outcomes
Primary Outcomes
30-day mortality rate from the time of enrollment
Secondary Outcomes
- 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).
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