KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

NCT00115479 | Completed Phase 2

• 3 other identifiers: S18630FWO grant number G.0278.03KULeuven OT/03/56
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

critical illness; intensive care; outcome; insulin; blood glucose

Outcome Measures

Primary Outcomes (1)

• mortality

Secondary Outcomes (6)

• mechanical ventilatory support-dependency

• stay in Intensive Care Unit (ICU)

• stay in hospital

• organ failure

• morbidity

Interventions

intensive insulin therapy to maintain normoglycemia DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• KU Leuven: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (1)

Catholic University of Leuven, University Hospital Gasthuisberg

Leuven, B-3000, Belgium

Location

Related Publications (4)

• 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.

  PMID: 11794168 BACKGROUND

• 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.

  PMID: 16452557 RESULT

• 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.

  PMID: 23506003 DERIVED

• 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.

  PMID: 19589139 DERIVED

MeSH Terms

Conditions

Critical Illness; Insulin Resistance

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Greet H Van den Berghe, MD, PhD

  K.U.Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2005
• First Posted: June 23, 2005
• Study Start: March 1, 2002
• Study Completion: June 1, 2005
• Last Updated: May 4, 2006

Record last verified: 2005-06

Locations

BE (1)