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

Strict Glucose Control of Pediatric ICU Patients to Reduce Mortality and Morbidity

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 Overview

• Status: Withdrawn
• Conditions: Sepsis; Respiratory Failure; Trauma; Cardiovascular Failure
• Intervention / Treatment: Procedure: Strict Glucose Control

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
30-day mortality rate from the time of enrollment

Secondary Outcome Measures

Outcome Measure
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).

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Vinay Nadkarni, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2004
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: November 1, 2005
• First Submitted That Met QC Criteria: November 1, 2005
• First Posted (Estimate): November 2, 2005

Study Record Updates

• Last Update Posted (Estimate): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2003-2-3160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No