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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00247468
Recruitment Status : Withdrawn (Never received IRB approval)
First Posted : November 2, 2005
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Cardiovascular Failure Sepsis Trauma Procedure: Strict Glucose Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Strict Glucose Control of Pediatric ICU Patients to Reduce Mortality and Morbidity
Actual Study Start Date : December 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose




Primary Outcome Measures :
  1. 30-day mortality rate from the time of enrollment

Secondary Outcome Measures :
  1. Pediatric Overall Performance Category scores at ICU discharge and 6 months post-discharge
  2. rates of nosocomial bloodstream infections
  3. time to resolution of organ failure (mechanical ventilator days and days of vasopressor support)
  4. change in Pediatric Logistic Organ Dysfunction scores
  5. requirement of dialysis or hemofiltration for patients with acute renal failure
  6. volume of blood product transfusions per kilogram body weight (vol/kg).


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247468


Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Vinay Nadkarni, MD Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00247468    
Other Study ID Numbers: 2003-2-3160
First Posted: November 2, 2005    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases