This trial is active, not recruiting.

Condition critical illness
Treatments intensive insulin therapy (actrapid iv to normoglycemia), conventional insulin therapy (actrapid iv only for excessive hyperglycemia)
Phase phase 2
Sponsor Greet Van den Berghe
Start date October 2004
End date February 2008
Trial size 700 participants
Trial identifier NCT00214916, PICU-insulin study


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
(Active Comparator)
conventional insulin therapy (using Actrapid IV)
conventional insulin therapy (actrapid iv only for excessive hyperglycemia) Actrapid IV only for excessive hyperglycemia
conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)
intensive insulin therapy (using actrapid IV)
intensive insulin therapy (actrapid iv to normoglycemia) Actrapid IV to normoglycemia
intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants up to 16 years old.

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

Additional Information

Official title KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients
Description Study type: Interventional study Study design: single centre, prospective, randomized, active control, parallel assignment, efficacy study
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by Katholieke Universiteit Leuven.