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

Primary Purpose

Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Hemorrhage

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Insulin (Actrapid)

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring Neurointensive care, Intensive insulin infusion, Hypoglycemia, Postoperative Mortality, Postoperative Morbidity, Neurologic outcome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subarachnoid hemorrhage
Traumatic brain injury
Intracranial hemorrhage

Sites / Locations

University of Rome La SapienzaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Insulin infusion rate titrated to maintain glycemia between 80 and 100 mg/dl

Insulin infusion rate titrated to maintain glycemia between 80 and 220 mg/dl

Outcomes

Primary Outcome Measures

Episodes of hypoglycemia

Secondary Outcome Measures

Infection rate

Vasospasm rate

Mortality

Neurologic status

Full Information

NCT ID

NCT00505505

First Posted

July 20, 2007

Last Updated

August 6, 2008

Sponsor

University of Roma La Sapienza

1. Study Identification

Unique Protocol Identification Number

NCT00505505

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Roma La Sapienza

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subarachnoid Hemorrhage, Traumatic Brain Injury, Intracranial Hemorrhage

Keywords

Neurointensive care, Intensive insulin infusion, Hypoglycemia, Postoperative Mortality, Postoperative Morbidity, Neurologic outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Insulin infusion rate titrated to maintain glycemia between 80 and 100 mg/dl

Arm Title

Arm Type

Active Comparator

Arm Description

Insulin infusion rate titrated to maintain glycemia between 80 and 220 mg/dl

Intervention Type

Drug

Intervention Name(s)

Insulin (Actrapid)

Intervention Description

50 UI Actrapid diluted in 50 ml of saline

Primary Outcome Measure Information:

Title

Episodes of hypoglycemia

Secondary Outcome Measure Information:

Title

Infection rate

Time Frame

during the study

Title

Vasospasm rate

Time Frame

during the study

Title

Mortality

Time Frame

6 months follow up

Title

Neurologic status

Time Frame

6 months follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subarachnoid hemorrhage Traumatic brain injury Intracranial hemorrhage

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Federico Bilotta, MD, PhD

Phone

39 339 33 708 22

bilotta@tiscali.it

First Name & Middle Initial & Last Name or Official Title & Degree

Vincenzo Cuzzone

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Federico Bilotta, MD, PhD

Organizational Affiliation

Department of Anesthesiology, Critical Care and Pain Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

University of Rome La Sapienza

City

Rome

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Federico Bilotta, MD, PhD

bilotta@tiscali.it

12. IPD Sharing Statement

Learn more about this trial

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

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