Tight Glycemic Control in Critical Care Patients
Phase 3
Completed
- Conditions
- Critical IllnessHyperglycemiaInsulin Resistance
- Registration Number
- NCT00096421
- Lead Sponsor
- Hospital Pablo Tobón Uribe
- Brief Summary
The purpose of this study is to evaluate the impact of tight control of serum glucose levels with an intensive insulin treatment in patients hospitalized in an intensive care unit with medical and surgical patients.
- Detailed Description
Reduction of morbidity-mortality in critical care patients with tight glycemic control had been proven in surgical patients only.
Study Hypothesis: In critical care patients, medical or surgical, a glucose serum level between 80 - 110 mg/dL means a lower mortality than patients with glucose levels of more than 110 mg/dL.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 504
Inclusion Criteria
- 15 years of age or older,
- Probability of staying in critical care for more than 48 hours,
- Agreement with the informed consent.
Exclusion Criteria
- Pregnancy,
- Participating in other trials,
- Diabetic keto-acidosis or diabetic hyperosmolar state,
- Moribund
- Do-not-resuscitate orders,
- Reentry to the critical care unit of the same patient.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mortality in the next 28 days
- Secondary Outcome Measures
Name Time Method Days of ventilatory support Acute renal failure requiring dialysis or hemofiltration Mortality during intensive care Mortality overall in-hospital Mortality among patients who remained in the intensive care unit for more than five days Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection Length of stay in the unit The median number of red-cell transfusions SOFA score Critical-illness polyneuropathy
Trial Locations
- Locations (1)
Hospital Pablo Tobon Uribe
🇨🇴Medellin, Antioquia, Colombia