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Glucose Regulation in Acute Stroke Patients (GRASP) Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282867
First Posted: January 27, 2006
Last Update Posted: August 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
University of Virginia
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glucose Regulation in Acute Stroke Patients (GRASP) Study

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Hypoglycemic Events [ Time Frame: up to 5 days ]

Secondary Outcome Measures:
  • Favorable 3 Month Modified Rankin [ Time Frame: 3 months ]

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
Active Comparator: tight control group
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.
Active Comparator: loose control group
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.
Active Comparator: usual care group
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Karen C. Johnston, MD, MSc, PI, Professor and Chair Department of Neurology, University of Virginia
ClinicalTrials.gov Identifier: NCT00282867     History of Changes
Other Study ID Numbers: 11901
R01NS050192 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2006
First Posted: January 27, 2006
Results First Submitted: July 14, 2009
Results First Posted: August 21, 2009
Last Update Posted: August 21, 2009
Last Verified: July 2009

Keywords provided by University of Virginia:
stroke
acute ischemic stroke
hyperglycemia
glucose
insulin
insulin and potassium therapy
GIK

Additional relevant MeSH terms:
Stroke
Hyperglycemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs