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
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00505505
First received: July 20, 2007
Last updated: August 6, 2008
Last verified: July 2007
  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
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).

  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
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 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

No publications provided

ClinicalTrials.gov 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
Hypoglycemia
Postoperative Mortality
Postoperative Morbidity
Neurologic outcome

Additional relevant MeSH terms:
Brain Injuries
Hemorrhage
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014