Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy
Phase 4
- Conditions
- Subarachnoid HemorrhageTraumatic Brain InjuryIntracranial Hemorrhage
- Interventions
- Drug: Insulin (Actrapid)
- Registration Number
- NCT00505505
- Lead Sponsor
- University of Roma La Sapienza
- Brief Summary
Strict glycemic control improves mortality and morbidity of patients admitted to the postoperative intensive care unit (ICU). The investigators would like to know if this therapy could improve the long term neurologic and cognitive outcomes of patients treated for acute subarachnoid hemorrhage with either a surgical or intravascular approach.
- Detailed Description
Intensive Insulin Therapy and Strict Glycemic Control (80-120 mg/dL) Versus Standard Insulin Therapy in Neurosurgical Intensive Care Patients (Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Expanding Lesion): Safety, and Efficacy (Mortality, Morbidity, Long Term Neurologic Outcome).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
- Subarachnoid hemorrhage
- Traumatic brain injury
- Intracranial hemorrhage
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Insulin (Actrapid) Insulin infusion rate titrated to maintain glycemia between 80 and 220 mg/dl A Insulin (Actrapid) Insulin infusion rate titrated to maintain glycemia between 80 and 100 mg/dl
- Primary Outcome Measures
Name Time Method Episodes of hypoglycemia
- Secondary Outcome Measures
Name Time Method Infection rate during the study Vasospasm rate during the study Mortality 6 months follow up Neurologic status 6 months follow up
Trial Locations
- Locations (1)
University of Rome La Sapienza
🇮🇹Rome, Italy