Tight Glycemic Control With Intensive Insulin Therapy in PICU

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

Official Title
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KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: intensive insulin therapy (Actrapid IV to normoglycemia)
* Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of inflammation |  | during ICU stay to day 5 | 
| duration of dependency on intensive care (days in ICU) |  | time in ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tight glycemic control with, intensive insulin treatment, versus conventional glycemic control, in infant or child in ICU