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

NCT ID: NCT00247468

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Failure Cardiovascular Failure Sepsis Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Strict Glucose Control

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vinay Nadkarni, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Other Identifiers

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2003-2-3160

Identifier Type: -

Identifier Source: org_study_id

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