Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke
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|ClinicalTrials.gov Identifier: NCT00747279|
Recruitment Status : Unknown
Verified September 2008 by Hospital Sao Domingos.
Recruitment status was: Recruiting
First Posted : September 5, 2008
Last Update Posted : September 9, 2008
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke||Other: Carbohydrate restrictive strategy Drug: Intensive insulin therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke|
|Study Start Date :||June 2007|
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.
- Neurological outcome through the Glasgow Outcome Scale Extended [ Time Frame: At least 4 months after hospital discharge ]
- NIHSS during ICU stay [ Time Frame: ICU stay ]
- Hospital mortality [ Time Frame: Hospital stay ]
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
|Contact: JOSE R AZEVEDO, MD||55 98 email@example.com|
|Hospital Sao Domingos||Recruiting|
|Sao Luis, MA, Brazil, 65060-642|
|Contact: JOSE R AZEVEDO, MD 55 98 32275735 firstname.lastname@example.org|
|Principal Investigator: JOSE R AZEVEDO, MD|