Glucose Regulation in Acute Stroke Patients (GRASP) Study

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.