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.
Study type: Interventional study Study design: single centre, prospective, randomized, active control, parallel assignment, efficacy study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
700
intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)
conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)
Dep Intensive Care Medicine University Hospital Leuven
Leuven, Belgium
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.