KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Critical Illness	Drug: intensive insulin therapy to maintain normoglycemia	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Diabetes Medicines

Drug Information available for: Insulin human

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:

mortality

Secondary Outcome Measures:

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

Estimated Enrollment:	1200
Study Start Date:	March 2002
Estimated Study Completion Date:	June 2005

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115479

Locations

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

Sponsors and Collaborators

Katholieke Universiteit Leuven

Fund for Scientific Research, Flanders, Belgium

Novo Nordisk

Investigators

Principal Investigator:

Greet H Van den Berghe, MD, PhD

K.U.Leuven

More Information

Publications:

Van den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, Van Wijngaerden E, Bobbaers H, Bouillon R. Intensive insulin therapy in the medical ICU. N Engl J Med. 2006 Feb 2;354(5):449-61.

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 the critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Boonen E, Vervenne H, Meersseman P, Andrew R, Mortier L, Declercq PE, Vanwijngaerden YM, Spriet I, Wouters PJ, Vander Perre S, Langouche L, Vanhorebeek I, Walker BR, Van den Berghe G. Reduced cortisol metabolism during critical illness. N Engl J Med. 2013 Apr 18;368(16):1477-88. doi: 10.1056/NEJMoa1214969. Epub 2013 Mar 19.

Langouche L, Vander Perre S, Frystyk J, Flyvbjerg A, Hansen TK, Van den Berghe G. Adiponectin, retinol-binding protein 4, and leptin in protracted critical illness of pulmonary origin. Crit Care. 2009;13(4):R112. Epub 2009 Jul 9.

ClinicalTrials.gov Identifier:	NCT00115479 History of Changes
Other Study ID Numbers:	S18630, FWO grant number G.0278.03, KULeuven OT/03/56
Study First Received:	June 22, 2005
Last Updated:	May 3, 2006
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:

critical illness
intensive care
outcome
insulin
blood glucose

Additional relevant MeSH terms:

Critical Illness
Disease Attributes
Pathologic Processes
Insulin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013