Tight Glycemic Control With Intensive Insulin Therapy in PICU

Sponsor

Greet Van den Berghe (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00214916

Collaborator

(none)

700

Enrollment

Location

Arms

224

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Drug: intensive insulin therapy (Actrapid IV to normoglycemia) Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)	Phase 2

Detailed Description

Study type: Interventional study

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

Study Design

Study Type:

Interventional

Actual Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Feb 1, 2008

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A conventional insulin therapy (using Actrapid IV)	Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia) conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl) Other Names: Actrapid IV only for excessive hyperglycemia
Experimental: B intensive insulin therapy (using actrapid IV)	Drug: intensive insulin therapy (Actrapid IV to normoglycemia) intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia) Other Names: Actrapid IV to normoglycemia

Arm

Intervention/Treatment

Active Comparator: A

conventional insulin therapy (using Actrapid IV)

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

conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)

Other Names:

Actrapid IV only for excessive hyperglycemia

Experimental: B

intensive insulin therapy (using actrapid IV)

Drug: intensive insulin therapy (Actrapid IV to normoglycemia)

intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)

Other Names:

Actrapid IV to normoglycemia

Outcome Measures

Primary Outcome Measures

Reduction of inflammation [during ICU stay to day 5]
duration of dependency on intensive care (days in ICU) [time in ICU]

Secondary Outcome Measures

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