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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00505505
• Other study ID #: 1781964
• Status: Recruiting
• Phase: Phase 4
• First received: July 20, 2007
• Last updated: August 6, 2008
• Start date: January 2002

Study information

• Verified date: July 2007
• Source: University of Roma La Sapienza
• Contact: Federico Bilotta, MD, PhD
• Phone: 39 339 33 708 22
• Email: bilotta[@]tiscali.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 800
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subarachnoid hemorrhage

• Traumatic brain injury

• Intracranial hemorrhage

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhage
• Intracranial Hemorrhages
• Subarachnoid Hemorrhage
• Traumatic Brain Injury

Intervention

Drug:
• Insulin (Actrapid)
50 UI Actrapid diluted in 50 ml of saline

Locations

Country	Name	City	State
Italy	University of Rome La Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Episodes of hypoglycemia
Secondary	Infection rate		during the study
Secondary	Vasospasm rate		during the study
Secondary	Mortality		6 months follow up
Secondary	Neurologic status		6 months follow up