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

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ClinicalTrials.gov Identifier: NCT00505505
Recruitment Status : Unknown
Verified July 2007 by University of Roma La Sapienza.
Recruitment status was:  Recruiting
First Posted : July 23, 2007
Last Update Posted : August 7, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Traumatic Brain Injury Intracranial Hemorrhage Drug: Insulin (Actrapid) Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients
Study Start Date : January 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
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
Active Comparator: B
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



Primary Outcome Measures :
  1. Episodes of hypoglycemia

Secondary Outcome Measures :
  1. Infection rate [ Time Frame: during the study ]
  2. Vasospasm rate [ Time Frame: during the study ]
  3. Mortality [ Time Frame: 6 months follow up ]
  4. Neurologic status [ Time Frame: 6 months follow up ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subarachnoid hemorrhage
  • Traumatic brain injury
  • Intracranial hemorrhage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00505505     History of Changes
Other Study ID Numbers: 1781964
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: August 7, 2008
Last Verified: July 2007

Keywords provided by University of Roma La Sapienza:
Neurointensive care
Intensive insulin infusion
Hypoglycemia
Postoperative Mortality
Postoperative Morbidity
Neurologic outcome

Additional relevant MeSH terms:
Brain Injuries
Hemorrhage
Brain Injuries, Traumatic
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs