KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- KU Leuven
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- mortality
- Status
- Completed
- Last Updated
- 20 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
mortality
Secondary Outcomes
- 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