KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients

Greet Van den Berghe1 site in 1 country700 target enrollmentOctober 2004

Interventionsconventional insulin therapy (Actrapid IV only for excessive hyperglycemia)intensive insulin therapy (Actrapid IV to normoglycemia)

Drugsintensive insulin therapy (Actrapid IV to normoglycemia)conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)

Overview

Phase: Phase 2
Intervention: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)
Conditions: Critical Illness
Sponsor: Greet Van den Berghe
Enrollment: 700
Locations: 1
Primary Endpoint: duration of dependency on intensive care (days in ICU)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

In a previous study, the investigators showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality in adult intensive care patients. Whether this intervention also improves prognosis of pediatric intensive care patients remains unknown. The current prospective, randomized, controlled study will asses the impact of intensive insulin therapy on outcome of patients in a pediatric intensive care unit. On admission patients will be randomly assigned to either strict normalization of blood glucose according age adjusted values or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl to maintain blood glucose levels between 180-200 mg/dl.

Detailed Description

Study type: Interventional study Study design: single centre, prospective, randomized, active control, parallel assignment, efficacy study

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

June 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Greet Van den Berghe

Responsible Party

Sponsor Investigator

Principal Investigator

Greet Van den Berghe

Head of Dept and laboratory of Intensive Care Medicine

KU Leuven

Eligibility Criteria

Inclusion Criteria

•Children admitted to the pediatric intensive care unit and anticipated to require intensive care for at least 24 hours

Exclusion Criteria

•Expected stay \< 24 hours
•Therapy restriction upon admission
•No informed consent
•Other study enrollment

Arms & Interventions

A

conventional insulin therapy (using Actrapid IV)

Intervention: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)

B

intensive insulin therapy (using actrapid IV)

Intervention: intensive insulin therapy (Actrapid IV to normoglycemia)

Outcomes

Primary Outcomes

duration of dependency on intensive care (days in ICU)

Time Frame: time in ICU

Reduction of inflammation

Time Frame: during ICU stay to day 5

Secondary Outcomes

mortality (safety endpoint)(during time in ICU)
Duration mechanical ventilation(during time in ICU)
Organ failure/need for organ support(during time in ICU)
long-term follow-up study : focus on neurocognitive development (ethical approval granted)(3 years (+/- 6 months) after randomization)