Clinical trial NCT00115479: KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients
Official title: KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Critical Illness
Keywords: critical illness
intensive care
outcome
insulin
blood glucose
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
name: Novo Nordisk A/S
First posted: 2005-06-23
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: mortality
Secondary outcomes:
measure: mechanical ventilatory support-dependency
measure: stay in Intensive Care Unit (ICU)
measure: stay in hospital
measure: organ failure
measure: morbidity
measure: a long-term follow up is planned to take place 6 and 12 months after hospital discharge
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Catholic University of Leuven, University Hospital Gasthuisberg
Study officials:
affiliation: K.U.Leuven
name: Greet H Van den Berghe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1056/NEJMoa011300.
citation: 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.
citation: 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.
citation: 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.