Strict Glucose Control of Pediatric Intensive Care Unit (... | NCT00247468

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

NCT00247468

Sponsor

Children's Hospital of Philadelphia

Status

Withdrawn

Last Update Posted

Jan 23, 2017Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Respiratory Failure
Cardiovascular Failure
Sepsis
Trauma

Interventions

Strict Glucose Control

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Never received IRB approval

Expanded Access Info

Start Date

Dec 2004Actual

Primary Completion Date

Dec 2004Actual

Completion Date

Dec 2004Actual

First Submitted Date

Nov 1, 2005

First Submission Date that Met QC Criteria

Nov 1, 2005

First Posted Date

Nov 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2017

Last Update Posted Date

Jan 23, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Strict Glucose Control	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
30-day mortality rate from the time of enrollment

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vinay Nadkarni, MD	Children's Hospital of Philadelphia	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency
D018805	Sepsis
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome

Browse Leaves

Not provided

Browse Branches

Not provided