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

NCT ID: NCT00505505

Last Updated: 2008-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Brief Summary

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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

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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).

Conditions

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Subarachnoid Hemorrhage Traumatic Brain Injury Intracranial Hemorrhage

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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A

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

Group Type EXPERIMENTAL

Insulin (Actrapid)

Intervention Type DRUG

50 UI Actrapid diluted in 50 ml of saline

B

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

Group Type ACTIVE_COMPARATOR

Insulin (Actrapid)

Intervention Type DRUG

50 UI Actrapid diluted in 50 ml of saline

Interventions

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Insulin (Actrapid)

50 UI Actrapid diluted in 50 ml of saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subarachnoid hemorrhage
* Traumatic brain injury
* Intracranial hemorrhage
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Principal Investigators

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Federico Bilotta, MD, PhD

Role: STUDY_CHAIR

Department of Anesthesiology, Critical Care and Pain Medicine

Locations

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University of Rome La Sapienza

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Federico Bilotta, MD, PhD

Role: CONTACT

Phone: 39 339 33 708 22

Email: [email protected]

Vincenzo Cuzzone

Role: CONTACT

Facility Contacts

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Federico Bilotta, MD, PhD

Role: primary

Other Identifiers

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1781964

Identifier Type: -

Identifier Source: org_study_id