Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke
Primary Purpose
Acute Ischemic Stroke
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Carbohydrate restrictive strategy
Intensive insulin therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility 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
Sites / Locations
- Hospital Sao DomingosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Carbohydrate restrictive strategy
Intensive insulin therapy
Outcomes
Primary Outcome Measures
Neurological outcome through the Glasgow Outcome Scale Extended
Secondary Outcome Measures
NIHSS during ICU stay
Hospital mortality
Full Information
NCT ID
NCT00747279
First Posted
September 4, 2008
Last Updated
September 8, 2008
Sponsor
Hospital Sao Domingos
1. Study Identification
Unique Protocol Identification Number
NCT00747279
Brief Title
Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke
Official Title
Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Sao Domingos
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Carbohydrate restrictive strategy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intensive insulin therapy
Intervention Type
Other
Intervention Name(s)
Carbohydrate restrictive strategy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intensive insulin therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neurological outcome through the Glasgow Outcome Scale Extended
Time Frame
At least 4 months after hospital discharge
Secondary Outcome Measure Information:
Title
NIHSS during ICU stay
Time Frame
ICU stay
Title
Hospital mortality
Time Frame
Hospital stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JOSE R AZEVEDO, MD
Phone
55 98 32275735
Email
jrazevedo@elo.com.br
Facility Information:
Facility Name
Hospital Sao Domingos
City
Sao Luis
State/Province
MA
ZIP/Postal Code
65060-642
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JOSE R AZEVEDO, MD
Phone
55 98 32275735
Email
jrazevedo@elo.com.br
First Name & Middle Initial & Last Name & Degree
JOSE R AZEVEDO, MD
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke
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