Status:
COMPLETED
Glucose Regulation in Acute Stroke Patients (GRASP) Study
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Stroke
Hyperglycemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the feasibility, safety and preliminary efficacy of the use of insulin infusions as treatment for hyperglycemic acute ischemic stroke patients.
Detailed Description
Ischemic stroke is a common, devastating and costly disease. Half of acute stroke patients have elevated glucose levels upon admission to the hospital, and hyperglycemia is associated with poor outcom...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more major vessels.
- Must arrive at hospital and be able to begin treatment within 2 hours of established eligibility and this must be within 24 hours of symptom onset. - - Patients unable to report symptom onset time or those awakening with symptoms must use the time last known to be well as the onset time.
- Admission plasma glucose of \> 110 mg/dL.
Exclusion
- Renal dysfunction as defined by a serum creatinine of \>/=2.5 mg/dL at enrollment.
- Substantial pre-existing neurological or psychiatric illness that would confound neurological assessment.
- Patients who have received experimental therapy for the enrollment stroke.
- Pregnant females.
- Patients with other severe life threatening conditions that makes them unlikely to survive 90 days.
- Patients who are unable to follow the protocol or come back for 90-day followup.
- Patient has condition for which insulin infusion is the usual practice or the treating physician feels that there is an indication for insulin infusion.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00282867
Start Date
May 1 2006
End Date
February 1 2009
Last Update
August 21 2009
Active Locations (2)
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1
Medical College of Georgia
Augusta, Georgia, United States, 30912
2
University of Virginia
Charlottesville, Virginia, United States, 22908