KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

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 Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Drug: intensive insulin therapy to maintain normoglycemia

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 Type: Interventional
• Enrollment: 1200
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
mortality

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Novo Nordisk A/S; Fund for Scientific Research, Flanders, Belgium
• Investigators: Principal Investigator: Greet H Van den Berghe, MD, PhD, K.U.Leuven

Publications and helpful links

General 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. doi: 10.1056/NEJMoa011300.
• 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. doi: 10.1056/NEJMoa052521.
• 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. doi: 10.1186/cc7956. Epub 2009 Jul 9.

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Primary Completion: December 7, 2022
• Study Completion: June 1, 2005

Study Registration Dates

• First Submitted: June 22, 2005
• First Submitted That Met QC Criteria: June 22, 2005
• First Posted (Estimate): June 23, 2005

Study Record Updates

• Last Update Posted (Estimate): May 4, 2006
• Last Update Submitted That Met QC Criteria: May 3, 2006
• Last Verified: June 1, 2005

More Information

Terms related to this study

• Keywords: outcome; intensive care; insulin; blood glucose; critical illness
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Hypoglycemic Agents; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Insulin; Benzocaine
• Other Study ID Numbers: S18630; FWO grant number G.0278.03; KULeuven OT/03/56

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No