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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00247468
• Other study ID #: 2003-2-3160
• Status: Withdrawn
• Phase: N/A
• First received: November 1, 2005
• Last updated: January 19, 2017
• Start date: December 2004
• Est. completion date: December 2004

Study information

• Verified date: January 2017
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Failure
• Respiratory Failure
• Respiratory Insufficiency
• Sepsis
• Trauma

Intervention

Procedure:
• Strict Glucose Control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality rate from the time of enrollment
Secondary	Pediatric Overall Performance Category scores at ICU discharge and 6 months post-discharge
Secondary	rates of nosocomial bloodstream infections
Secondary	time to resolution of organ failure (mechanical ventilator days and days of vasopressor support)
Secondary	change in Pediatric Logistic Organ Dysfunction scores
Secondary	requirement of dialysis or hemofiltration for patients with acute renal failure
Secondary	volume of blood product transfusions per kilogram body weight (vol/kg).