MedTrace Logo

Tight Glycemic Control With Intensive Insulin Therapy in PICU

NCT00214916 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2022-03-10

No results posted yet for this study

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.

Conditions

  • Critical Illness

Interventions

DRUG

intensive insulin therapy (Actrapid IV to normoglycemia)

intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)

DRUG

conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)

conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)

Sponsors & Collaborators

  • Greet Van den Berghe

    lead OTHER

Principal Investigators

  • Greet Van den Berghe, MD,PhD · Catholic University Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2008-02-29
Completion
2023-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00214916 on ClinicalTrials.gov