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-dependencystay 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
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