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
  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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Cerebral Infarction
Ischemia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014