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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by University of Roma La Sapienza.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00505505
First Posted: July 23, 2007
Last Update Posted: August 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Roma La Sapienza
  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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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
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

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

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00505505     History of Changes
Other Study ID Numbers: 1781964
First Submitted: July 20, 2007
First Posted: July 23, 2007
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