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KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

Information source: Katholieke Universiteit Leuven
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Critical Illness

Intervention: intensive insulin therapy to maintain normoglycemia (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Katholieke Universiteit Leuven

Official(s) and/or principal investigator(s):
Greet H Van den Berghe, MD, PhD, Principal Investigator, Affiliation: K.U.Leuven

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.

Clinical Details

Official title: KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome: mortality

Secondary outcome:

mechanical ventilatory support-dependency

stay in Intensive Care Unit (ICU)

stay in hospital

organ failure

morbidity

a long-term follow up is planned to take place 6 and 12 months after hospital discharge

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Catholic University of Leuven, University Hospital Gasthuisberg, Leuven B-3000, Belgium
Additional Information

Related publications:

van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67.

Starting date: March 2002
Last updated: May 3, 2006

Page last updated: August 23, 2015

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