KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

Critical Illness Clinical Trial

Official title:

KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115479
• Other study ID #: S18630
• Secondary ID: FWO grant number
• Status: Completed
• Phase: Phase 2
• First received: June 22, 2005
• Last updated: May 3, 2006
• Start date: March 2002
• Est. completion date: June 2005

Study information

• Verified date: June 2005
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• intensive insulin therapy to maintain normoglycemia

Locations

Country	Name	City	State
Belgium	Catholic University of Leuven, University Hospital Gasthuisberg	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven	Fund for Scientific Research, Flanders, Belgium, Novo Nordisk A/S

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality
Secondary	mechanical ventilatory support-dependency
Secondary	stay in Intensive Care Unit (ICU)
Secondary	stay in hospital
Secondary	organ failure
Secondary	morbidity
Secondary	a long-term follow up is planned to take place 6 and 12 months after hospital discharge