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Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by Hospital Sao Domingos.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00747279
First Posted: September 5, 2008
Last Update Posted: September 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Sao Domingos
  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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • NIHSS during ICU stay [ Time Frame: ICU stay ]
  • Hospital mortality [ Time Frame: Hospital stay ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00747279     History of Changes
Other Study ID Numbers: HSD001
First Submitted: September 4, 2008
First Posted: September 5, 2008
Last Update Posted: September 9, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs