Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke - Full Text View

Sponsored by:	Hospital Sao Domingos
Information provided by:	Hospital Sao Domingos
ClinicalTrials.gov Identifier:	NCT00747279

Purpose

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.

Condition	Intervention	Phase
Acute Ischemic Stroke	Other: Carbohydrate restrictive strategy Drug: Intensive insulin therapy	Phase IV

Drug Information available for: Insulin Dextrose Lipids Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Safety/Efficacy Study
Official Title:	Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

Further study details as provided by Hospital Sao Domingos:

Primary Outcome Measures:

Neurological outcome through the Glasgow Outcome Scale Extended [ Time Frame: At least 4 months after hospital discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

NIHSS during ICU stay [ Time Frame: ICU stay ] [ Designated as safety issue: Yes ]
Hospital mortality [ Time Frame: Hospital stay ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	June 2007

Arms	Assigned Interventions
1: Experimental Carbohydrate restrictive strategy	Other: 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.
2: Active Comparator Intensive insulin therapy	Drug: 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.

Arms

Assigned Interventions

1: Experimental

Carbohydrate restrictive strategy

Other: 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.

2: Active Comparator

Intensive insulin therapy

Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747279

Contacts

Contact: JOSE R AZEVEDO, MD

55 98 32275735

jrazevedo@elo.com.br

Locations

Brazil, MA
Hospital Sao Domingos	Recruiting
SAO LUIS, MA, Brazil, 65060-642
Contact: JOSE R AZEVEDO, MD 55 98 32275735 jrazevedo@elo.com.br
Principal Investigator: JOSE R AZEVEDO, MD

Sponsors and Collaborators

Hospital Sao Domingos

More Information

Study ID Numbers:	HSD001
Study First Received:	September 4, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00747279
Health Authority:	Brazil: National Committee of Ethics in Research

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Benzocaine
Vascular Diseases
Central Nervous System Diseases

Ischemia
Brain Diseases
Cerebrovascular Disorders
Insulin

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009