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Glucose Regulation in Acute Stroke Patients (GRASP) Study

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ClinicalTrials.gov Identifier: NCT00282867
Recruitment Status : Completed
First Posted : January 27, 2006
Results First Posted : August 21, 2009
Last Update Posted : August 21, 2009
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
University of Virginia

Tracking Information
First Submitted Date  ICMJE January 26, 2006
First Posted Date  ICMJE January 27, 2006
Results First Submitted Date  ICMJE July 14, 2009
Results First Posted Date  ICMJE August 21, 2009
Last Update Posted Date August 21, 2009
Study Start Date  ICMJE May 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2009)
Hypoglycemic Events [ Time Frame: up to 5 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2006)
The proportion of patients with hypoglycemia at any time as determined by Accu-chek glucose levels of <55mg/dL.
Change History Complete list of historical versions of study NCT00282867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2009)
Favorable 3 Month Modified Rankin [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glucose Regulation in Acute Stroke Patients (GRASP) Study
Official Title  ICMJE Glucose Regulation in Acute Stroke Patients (GRASP) Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Hyperglycemia
Intervention  ICMJE
  • Drug: IV glucose insulin and potassium, GIK
    The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.
  • Other: standard care
    usual care
Study Arms  ICMJE
  • Active Comparator: tight control group
    target glucose level 70-110 mg/dL
    Intervention: Drug: IV glucose insulin and potassium, GIK
  • Active Comparator: loose control group
    target glucose level 70 - 200 mg/dL
    Intervention: Drug: IV glucose insulin and potassium, GIK
  • Active Comparator: usual care group
    target level 70 - 300 mg/dL
    Intervention: Other: standard care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2007)
74
Original Enrollment  ICMJE
 (submitted: January 26, 2006)
80
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282867
Other Study ID Numbers  ICMJE 11901
R01NS050192 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karen C. Johnston, MD, MSc, PI, Professor and Chair Department of Neurology, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Karen Johnston, MD University of Virginia, Department of Neurology
PRS Account University of Virginia
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP