Strict Glucose Control of Pediatric Intensive Care Unit (ICU) Patients

Children's Hospital of Philadelphia

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Respiratory Failure Cardiovascular Failure Sepsis Trauma

Interventions

Strict Glucose ControlPROCEDURE

Eligibility

Sex: ALLMin age: 1 MonthMax age: 21 Years

Medical Language ↔ Plain English

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).

Data from ClinicalTrials.gov

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