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Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

NCT ID: NCT00747279

Last Updated: 2008-09-09

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Brief Summary

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The purpose of this prospective randomized controlled trial was to compare intensive insulin therapy with a carbohydrate restrictive strategy in patients with acute ischemic stroke evaluating the outcome through the Glasgow Outcome Scale Extended, hospital mortality and NIHSS during the ICU stay.

Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Carbohydrate restrictive strategy

Group Type EXPERIMENTAL

Carbohydrate restrictive strategy

Intervention Type OTHER

Patients will receive intravenous hydration with a glucose free solution (Ringer III) and enteral nutritional formula containing 33.3% carbohydrates, 16.7% proteins and 50% lipids. These patients will receive regular insulin subcutaneously four times daily, aiming to maintain blood glucose levels at least below 180 mg/dl, and in stable patients, ideally below 150 mg/dl.

2

Intensive insulin therapy

Group Type ACTIVE_COMPARATOR

Intensive insulin therapy

Intervention Type DRUG

Continuous intravenous regular insulin infusion will be adjusted to maintain glycemic levels at least below 150 mg/dl, and, in stable patients and ideally, between 80 and 120 mg/dl. Patients will be submitted to capillary glycemic measurements every 2 hours. The insulin dose is adjusted according to an algorithm run by nurses and overseen by physicians. These patients will receive glucosaline (5% glucose + 0.9 NaCl) hydration and enteral nutrition with a formula containing 45% carbohydrates, 17% proteins and 38% lipids.

Interventions

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Carbohydrate restrictive strategy

Patients will receive intravenous hydration with a glucose free solution (Ringer III) and enteral nutritional formula containing 33.3% carbohydrates, 16.7% proteins and 50% lipids. These patients will receive regular insulin subcutaneously four times daily, aiming to maintain blood glucose levels at least below 180 mg/dl, and in stable patients, ideally below 150 mg/dl.

Intervention Type OTHER

Intensive insulin therapy

Continuous intravenous regular insulin infusion will be adjusted to maintain glycemic levels at least below 150 mg/dl, and, in stable patients and ideally, between 80 and 120 mg/dl. Patients will be submitted to capillary glycemic measurements every 2 hours. The insulin dose is adjusted according to an algorithm run by nurses and overseen by physicians. These patients will receive glucosaline (5% glucose + 0.9 NaCl) hydration and enteral nutrition with a formula containing 45% carbohydrates, 17% proteins and 38% lipids.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients with acute ischemic stroke defined as: Abrupt onset of focal neurologic deficit
* No evidence of intracranial hemorrhage at non-contrasted CT scan.

Exclusion Criteria

* Age below 18
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sao Domingos

OTHER

Sponsor Role lead

Locations

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Hospital Sao Domingos

São Luís, Maranhão, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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JOSE R AZEVEDO, MD

Role: CONTACT

Phone: 55 98 32275735

Email: [email protected]

Facility Contacts

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JOSE R AZEVEDO, MD

Role: primary

Other Identifiers

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HSD001

Identifier Type: -

Identifier Source: org_study_id