Intracranial Hemorrhage, Subarachnoid Hemorrhage, Traumatic Brain Injury
Conditions
Keywords
Neurointensive care, Intensive insulin infusion, Hypoglycemia, Postoperative Mortality, Postoperative Morbidity, Neurologic outcome
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).
Interventions
DRUGInsulin (Actrapid)
50 UI Actrapid diluted in 50 ml of saline
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subarachnoid hemorrhage * Traumatic brain injury * Intracranial hemorrhage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Episodes of hypoglycemia | — |
Secondary
| Measure | Time frame |
|---|---|
| Infection rate | during the study |
| Vasospasm rate | during the study |
| Mortality | 6 months follow up |
| Neurologic status | 6 months follow up |
Countries
Italy
Contacts
Primary ContactFederico Bilotta, MD, PhD
Backup ContactVincenzo Cuzzone
Outcome results
None listed