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KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

NCT00115479 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2006-05-04

No results posted yet for this study

Summary

In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy 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 and 200 mg/dl.

Conditions

  • Critical Illness

Interventions

DRUG

intensive insulin therapy to maintain normoglycemia

Sponsors & Collaborators

  • Fund for Scientific Research, Flanders, Belgium

    collaborator OTHER

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • KU Leuven

    lead OTHER

Principal Investigators

  • Greet H Van den Berghe, MD, PhD · K.U.Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Completion
2005-06-30

Countries

  • Belgium

Study Locations

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Entities

Companies

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 NCT00115479 on ClinicalTrials.gov