Tight Glycemic Control With Intensive Insulin Therapy in PICU

Phase 2

• Conditions: Critical Illness
• Interventions: Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia); Drug: intensive insulin therapy (Actrapid IV to normoglycemia)

• Registration Number: NCT00214916
• Lead Sponsor: Greet Van den Berghe

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

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-21
• Study First Posted: 2005-09-22
• Primary Completion: 2008-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-10
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)	conventional insulin therapy (using Actrapid IV)
B	intensive insulin therapy (Actrapid IV to normoglycemia)	intensive insulin therapy (using actrapid IV)

Primary Outcome Measures

Name	Time	Method
duration of dependency on intensive care (days in ICU)	time in ICU
Reduction of inflammation	during ICU stay to day 5

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dep Intensive Care Medicine University Hospital Leuven; 🇧🇪 Leuven, Belgium