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

Primary Purpose

Respiratory Failure, Cardiovascular Failure, Sepsis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Strict Glucose Control
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

1 Month - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    30-day mortality rate from the time of enrollment

    Secondary Outcome Measures

    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).

    Full Information

    First Posted
    November 1, 2005
    Last Updated
    January 19, 2017
    Sponsor
    Children's Hospital of Philadelphia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00247468
    Brief Title
    Strict Glucose Control of Pediatric Intensive Care Unit (ICU) Patients
    Official Title
    Strict Glucose Control of Pediatric ICU Patients to Reduce Mortality and Morbidity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Never received IRB approval
    Study Start Date
    December 2004 (Actual)
    Primary Completion Date
    December 2004 (Actual)
    Study Completion Date
    December 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Hospital of Philadelphia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Failure, Cardiovascular Failure, Sepsis, Trauma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vinay Nadkarni, MD
    Organizational Affiliation
    Children's Hospital of Philadelphia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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