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

August 6, 2008 updated by: University of Roma La Sapienza

Effects of Intensive Insulin Therapy on Mortality, Morbidity and Long Term Neurologic Outcome in Neurosurgical Intensive Care Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

800

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Federico Bilotta, MD, PhD
  • Phone Number: 39 339 33 708 22
  • Email: bilotta@tiscali.it

Study Contact Backup

  • Name: Vincenzo Cuzzone

Study Locations

  • Italy
      • Rome, Italy
        • Recruiting
        • University of Rome La Sapienza
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subarachnoid hemorrhage
  • Traumatic brain injury
  • Intracranial hemorrhage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Episodes of hypoglycemia

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Study Chair: Federico Bilotta, MD, PhD, Department of Anesthesiology, Critical Care and Pain Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Registration Dates

First Submitted

July 20, 2007

First Submitted That Met QC Criteria

July 20, 2007

First Posted (Estimate)

July 23, 2007

Study Record Updates

Last Update Posted (Estimate)

August 7, 2008

Last Update Submitted That Met QC Criteria

August 6, 2008

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1781964

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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