Cardiovascular Failure, Respiratory Failure, Sepsis, Trauma
Conditions
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.
Interventions
PROCEDUREStrict Glucose Control
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day mortality rate from the time of enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| rates of nosocomial bloodstream infections | — |
| time to resolution of organ failure (mechanical ventilator days and days of vasopressor support) | — |
| Pediatric Overall Performance Category scores at ICU discharge and 6 months post-discharge | — |
| requirement of dialysis or hemofiltration for patients with acute renal failure | — |
| volume of blood product transfusions per kilogram body weight (vol/kg). | — |
| change in Pediatric Logistic Organ Dysfunction scores | — |
Outcome results
None listed