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.
- Insulin infusion (GIK) (glucose-insulin-potassium infusion (GIK))Drug
Intervention Desc: Recent data suggest that glucose-insulin-potassium infusion (GIK) in acute myocardial infarction results in an improved survival of patients, especially in patients undergoing reperfusion therapy.
- Standard Care Other
Intervention Desc: usual care ARM 1: Kind: Experimental Label: usual care group Description: target level 70 - 300 mg/dL
- IV glucose insulin and potassium, GIK Drug
Intervention Desc: The treatment intervention includes glucose, insulin, potassium infusion or standard therapy. ARM 1: Kind: Experimental Label: tight control group Description: target glucose level 70-110 mg/dL ARM 2: Kind: Experimental Label: loose control group Description: target glucose level 70 - 200 mg/dL
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Intervention: Parallel Assignment
Patients are randomized to tight glucose control (target 70 – 110 mg/dL), loose glucose control (70 – 200 mg/dL), or usual care. Enrollment will be stratified by baseline glucose and predicted probability of outcome. Subjects in the tight and loose control groups will receive insulin infusions titrated to the assigned target glucose level. Glucose and potassium will be given at a continuous rate and meal insulin will be provided with meals. The control group will receive usual care. All subjects will receive diabetic education and nutrition counseling. A subgroup of subjects will receive continuous glucose monitoring with subcutaneous monitors for 3 days.
|Type||Measure||Time Frame||Safety Issue|
|Primary||The primary safety outcome is the rate of hypoglycemic events (glucose <55mg/dL). The primary feasibility outcome is the frequency of subjects in target range within 24 hours of treatment initiation.|
|Secondary||NIH Stroke Scale, Barthel Index, Modified Rankin Scale, Glasgow Outcome Scale and the Stroke Impact Scale at 3 months.|
|Primary||Hypoglycemic Events||up to 5 days||Yes|
|Secondary||Favorable 3 Month Modified Rankin||3 months||No|