Intensive Insulin Therapy for Strict Glycemic Control in Neurosurgical Patients: Safety and Efficacy - Full Text View

Sponsored by:	University of Roma La Sapienza
Information provided by:	University of Roma La Sapienza
ClinicalTrials.gov Identifier:	NCT00505505

Purpose

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.

Condition	Intervention	Phase
Subarachnoid Hemorrhage Traumatic Brain Injury Intracranial Hemorrhage	Drug: Insulin (Actrapid)	Phase IV

MedlinePlus related topics: Hypoglycemia Traumatic Brain Injury

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:

Episodes of hypoglycemia

Secondary Outcome Measures:

Infection rate [ Time Frame: during the study ]
Vasospasm rate [ Time Frame: during the study ]
Mortality [ Time Frame: 6 months follow up ]
Neurologic status [ Time Frame: 6 months follow up ]

Estimated Enrollment:	800
Study Start Date:	January 2002

Arms	Assigned Interventions
A: Experimental Insulin infusion rate titrated to maintain glycemia between 80 and 100 mg/dl	Drug: Insulin (Actrapid) 50 UI Actrapid diluted in 50 ml of saline
B: Active Comparator Insulin infusion rate titrated to maintain glycemia between 80 and 220 mg/dl	Drug: Insulin (Actrapid) 50 UI Actrapid diluted in 50 ml of saline

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).

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subarachnoid hemorrhage
Traumatic brain injury
Intracranial hemorrhage

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505505

Contacts

Contact: Federico Bilotta, MD, PhD	39 339 33 708 22	bilotta@tiscali.it
Contact: Vincenzo Cuzzone

Locations

Italy
University of Rome La Sapienza	Recruiting
Rome, Italy
Contact: Federico Bilotta, MD, PhD bilotta@tiscali.it

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

Study Chair:

Federico Bilotta, MD, PhD

Department of Anesthesiology, Critical Care and Pain Medicine

More Information

Study ID Numbers:	1781964
Study First Received:	July 20, 2007
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00505505
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:

Neurointensive care
Intensive insulin infusion
Hypoglycemia

Postoperative Mortality
Postoperative Morbidity
Neurologic outcome

Study placed in the following topic categories:

Craniocerebral Trauma
Vascular Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Intracranial Hemorrhages
Trauma, Nervous System

Hypoglycemia
Hemorrhage
Brain Diseases
Cerebrovascular Disorders
Insulin
Subarachnoid Hemorrhage
Brain Injuries

Additional relevant MeSH terms:

Hypoglycemic Agents
Pathologic Processes
Physiological Effects of Drugs

Nervous System Diseases
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009