NCT00505505

Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy

Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Subarachnoid Hemorrhage
• Traumatic Brain Injury
• Intracranial Hemorrhage

Interventions

Type	Name	Description
DRUG	Insulin (Actrapid)	50 UI Actrapid diluted in 50 ml of saline

Timeline

• Start date: 2002-01-01
• First posted: 2007-07-23
• Last updated: 2008-08-07

Locations

1 site across 1 country: Italy