KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

Phase 2

Completed

• Conditions: Critical Illness

• Registration Number: NCT00115479
• Lead Sponsor: KU Leuven

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2002-03
• Status Verified: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-06-22
• Study First Submitted QC: 2005-06-22
• Study First Posted: 2005-06-23
• Last Update Submitted: 2006-05-03
• Last Update Posted: 2006-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Adults admitted to ICU and anticipated to require intensive care for at least a few days

Exclusion Criteria

• Expected short ICU stay
• Therapy restricted upon admission
• Surgical ICU patients
• Other studies
• Below 18 years
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mortality

Secondary Outcome Measures

Name	Time	Method
morbidity
mechanical ventilatory support-dependency
stay in Intensive Care Unit (ICU)
stay in hospital
organ failure
a long-term follow up is planned to take place 6 and 12 months after hospital discharge

Trial Locations

Locations (1)

Catholic University of Leuven, University Hospital Gasthuisberg; 🇧🇪 Leuven, Belgium