NCT00247468

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2004

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2005

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

Same day

First QC Date

November 1, 2005

Last Update Submit

January 19, 2017

Conditions

Respiratory FailureCardiovascular FailureSepsisTrauma

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality rate from the time of enrollment

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

Strict Glucose ControlPROCEDURE

Eligibility Criteria

Age1 Month - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Vasoactive infusion (e.g. dopamine, epinephrine, norepinephrine) and/or
  • Invasive mechanical ventilation
  • Age between 1 mo and 21 yrs

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory InsufficiencySepsisWounds and Injuries

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vinay Nadkarni, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2005

First Posted

November 2, 2005

Study Start

December 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

January 23, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share