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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by University of Roma La Sapienza.
Recruitment status was  Recruiting
Information provided by:
University of Roma La Sapienza Identifier:
First received: July 20, 2007
Last updated: August 6, 2008
Last verified: July 2007
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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).

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

Inclusion Criteria:

  • Subarachnoid hemorrhage
  • Traumatic brain injury
  • Intracranial hemorrhage
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00505505

Contact: Federico Bilotta, MD, PhD 39 339 33 708 22
Contact: Vincenzo Cuzzone

University of Rome La Sapienza Recruiting
Rome, Italy
Contact: Federico Bilotta, MD, PhD   
Sponsors and Collaborators
University of Roma La Sapienza
Study Chair: Federico Bilotta, MD, PhD Department of Anesthesiology, Critical Care and Pain Medicine
  More Information

No publications provided Identifier: NCT00505505     History of Changes
Other Study ID Numbers: 1781964
Study First Received: July 20, 2007
Last Updated: August 6, 2008
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Brain Injuries
Intracranial Hemorrhages
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Craniocerebral Trauma
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 25, 2015