Tight Glycemic Control With Intensive Insulin Therapy in PICU

Greet Van den Berghe

Status and phase: Unknown; Phase 2

Conditions: Critical Illness

Treatments: Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia); Drug: intensive insulin therapy (Actrapid IV to normoglycemia)

Study type: Interventional

Funder types: Other

Identifiers

NCT00214916

PICU-insulin study

NCT00214916

Details and patient eligibility

About

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.

Full description

Study type: Interventional study

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

Enrollment: 700 patients

Sex: All

Ages: 1 day to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

A

Active Comparator group

Description:

conventional insulin therapy (using Actrapid IV)

Treatment:

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

B

Experimental group

Description:

intensive insulin therapy (using actrapid IV)

Treatment:

Drug: intensive insulin therapy (Actrapid IV to normoglycemia)