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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

September 4, 2008
September 8, 2008
June 2007
Not Provided
Neurological outcome through the Glasgow Outcome Scale Extended [ Time Frame: At least 4 months after hospital discharge ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00747279 on ClinicalTrials.gov Archive Site
  • NIHSS during ICU stay [ Time Frame: ICU stay ] [ Designated as safety issue: Yes ]
  • Hospital mortality [ Time Frame: Hospital stay ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke
Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Acute Ischemic Stroke
  • 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.
  • 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.
  • Experimental: 1
    Carbohydrate restrictive strategy
    Intervention: Other: Carbohydrate restrictive strategy
  • Active Comparator: 2
    Intensive insulin therapy
    Intervention: Drug: Intensive insulin therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: JOSE R AZEVEDO, MD 55 98 32275735 jrazevedo@elo.com.br
Brazil
 
NCT00747279
HSD001
No
Not Provided
Hospital Sao Domingos
Not Provided
Not Provided
Hospital Sao Domingos
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP