Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2008 by Hospital Sao Domingos.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Hospital Sao Domingos

ClinicalTrials.gov Identifier:

NCT00747279

First received: September 4, 2008

Last updated: September 8, 2008

Last verified: September 2008

History of Changes

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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Insulin human

U.S. FDA Resources

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
Experimental: 1 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.
Active Comparator: 2 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

Experimental: 1

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.

Active Comparator: 2

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
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

No publications provided

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

Additional relevant MeSH terms:

Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

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