Glucose Regulation in Acute Stroke Patients (GRASP) Study

NCT ID: NCT00282867

Last Updated: 2009-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-02-28

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 outcome for post-stroke patients. It is unclear if treatment of hyperglycemia or glucose lowering improves outcome, however, in animal stroke models and other human conditions, aggressive glucose lowering is beneficial.

The goal of this multicenter trial is to determine if tight control of blood glucose is beneficial in hyperglycemic patients with acute ischemic stroke. In the trial, researchers will compare intravenous (IV) glucose insulin and potassium (GIK) therapy plus meal insulin to control therapy in 72 stroke patients.

Participants will be randomly assigned to one of three groups-(1) the control group with a target glucose level of <300mg/dL; (2) the tight control GIK plus meal insulin group with a target of <110mg/dL; or (3) the loose control GIK plus meal insulin group with a target of <200mg/dL-with all groups avoiding glucose levels of <70mg/dL.

The specific aims of this study are to collect preliminary data on the safety and feasibility of GIK for treatment of hyperglycemia in acute stroke patients, and to collect preliminary data comparing tight GIK therapy with loose GIK therapy and control therapy. Information learned in this study will compliment ongoing work and allow for maximum efficiency in the design of future treatment trials.

Conditions

Stroke; Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tight control group

target glucose level 70-110 mg/dL

Group Type: ACTIVE_COMPARATOR

IV glucose insulin and potassium, GIK

Intervention Type: DRUG

The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.

loose control group

target glucose level 70 - 200 mg/dL

Group Type: ACTIVE_COMPARATOR

IV glucose insulin and potassium, GIK

Intervention Type: DRUG

The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.

usual care group

target level 70 - 300 mg/dL

Group Type: ACTIVE_COMPARATOR

standard care

Intervention Type: OTHER

usual care

Interventions

IV glucose insulin and potassium, GIK

The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.

Intervention Type: DRUG

standard care

usual care

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

University of Virginia

Principal Investigators

Karen Johnston, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia, Department of Neurology

Locations

Medical College of Georgia

Augusta, Georgia, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

R01NS050192

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11901

Identifier Type: -

Identifier Source: org_study_id