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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Stroke
• Intervention / Treatment: Drug: IV glucose insulin and potassium, GIK; Other: standard 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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoglycemic Events	hypoglycemic events	up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Favorable 3 Month Modified Rankin	3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic Hypoglycemia	symptomatic hypoglycemia (glucose < 55 mg/dL)during treatment period	up to 5 days

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Karen Johnston, MD, University of Virginia, Department of Neurology

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (ACTUAL): February 1, 2008
• Study Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: January 26, 2006
• First Submitted That Met QC Criteria: January 26, 2006
• First Posted (ESTIMATE): January 27, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): August 21, 2009
• Last Update Submitted That Met QC Criteria: July 15, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: stroke; insulin; acute ischemic stroke; hyperglycemia; glucose; insulin and potassium therapy; GIK
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hyperglycemia; Stroke; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 11901; R01NS050192 (NIH)