Glucose Regulation in Acute Stroke Patients (GRASP) Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00282867
First received: January 26, 2006
Last updated: July 15, 2009
Last verified: July 2009

January 26, 2006
July 15, 2009
May 2006
February 2008   (final data collection date for primary outcome measure)
Hypoglycemic Events [ Time Frame: up to 5 days ] [ Designated as safety issue: Yes ]
The proportion of patients with hypoglycemia at any time as determined by Accu-chek glucose levels of <55mg/dL.
Complete list of historical versions of study NCT00282867 on ClinicalTrials.gov Archive Site
Favorable 3 Month Modified Rankin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Glucose Regulation in Acute Stroke Patients (GRASP) Study
Glucose Regulation in Acute Stroke Patients (GRASP) Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stroke
  • Hyperglycemia
  • Drug: IV glucose insulin and potassium, GIK
    The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.
  • Other: standard care
    usual care
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
February 2009
February 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00282867
11901, R01NS050192
Yes
Karen C. Johnston, MD, MSc, PI, Professor and Chair Department of Neurology, University of Virginia
University of Virginia
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Karen Johnston, MD University of Virginia, Department of Neurology
University of Virginia
July 2009

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