Glucose Regulation in Acute Stroke Patients (GRASP) Study - Full Text View

Sponsor:	University of Virginia
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	University of Virginia
ClinicalTrials.gov Identifier:	NCT00282867

Purpose

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.

Condition	Intervention	Phase
Stroke Hyperglycemia	Drug: IV glucose insulin and potassium, GIK Other: standard care	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Glucose Regulation in Acute Stroke Patients (GRASP) Study

Resource links provided by NLM:

Drug Information available for: Insulin Dextrose Potassium chloride

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:

Hypoglycemic Events [ Time Frame: up to 5 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Favorable 3 Month Modified Rankin [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	74
Study Start Date:	May 2006
Study Completion Date:	February 2009
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
tight control group: Active Comparator target glucose level 70-110 mg/dL	Drug: IV glucose insulin and potassium, GIK The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.
loose control group: Active Comparator target glucose level 70 - 200 mg/dL	Drug: IV glucose insulin and potassium, GIK The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.
usual care group: Active Comparator target level 70 - 300 mg/dL	Other: standard care usual care

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282867

Locations

United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

University of Virginia

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:

Karen Johnston, MD

University of Virginia, Department of Neurology

More Information

No publications provided

Responsible Party:	University of Virginia ( Karen C. Johnston, MD, MSc, PI, Professor and Chair Department of Neurology )
Study ID Numbers:	11901, R01NS050192
Study First Received:	January 26, 2006
Results First Received:	July 14, 2009
Last Updated:	July 15, 2009
ClinicalTrials.gov Identifier:	NCT00282867 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by University of Virginia:

stroke
acute ischemic stroke
hyperglycemia
glucose

insulin
insulin and potassium therapy
GIK

Additional relevant MeSH terms:

Metabolic Diseases
Cerebral Infarction
Physiological Effects of Drugs
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders

Pharmacologic Actions
Insulin
Hypoglycemic Agents
Hyperglycemia
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010