Ischemic stroke is a common, devastating and costly disease. Half of acute stroke patients have elevated admission glucose levels and hyperglycemia is associated with poor outcome. It is unclear if treatment of hyperglycemia improves outcome. Lack of data on treatment of hyperglycemia in acute stroke patients has resulted in a recommendation that glucose should be lowered to <300 mg/dL in the acute setting. In animal stroke models and other human conditions, aggressive glucose lowering is beneficial. Our team routinely uses continuous insulin infusions for critically ill neurological patients in the Neuro ICU. The risk benefit ratio of intravenous insulin in ischemic stroke patients requires evaluation and is the logical next step for an experimental therapeutic trial in closely monitored stroke units at UVA and MCG. This is a multicenter, randomized, open label (blinded outcomes) controlled trial comparing IV glucose, insulin and potassium (GIK) therapy plus meal insulin to control therapy in 72 acute ischemic stroke patients. Three groups will include: 1) Control Group: target glucose <300 mg/dL 2) Tight control GIK plus meal insulin group: target <110 mg/dL 3) Loose control GIK plus meal insulin group: target <200 mg/dL and all avoiding glucose levels <70 mg/dL.
Specific Aims : 1. to collect preliminary data on safety (hypoglycemia <55 mg/dL) and feasibility (in target at 24 hours) of GIK for treatment of hyperglycemia (>110 mg/dL) in acute ischemic stroke patients 2. to collect preliminary data comparing tight GIK therapy (70-110 mg/dL) to loose GIK therapy (70-200 mg/dL) and to control therapy (70-300 mg/dL) for hyperglycemia in ischemic stroke The information obtained will compliment ongoing work and allow for maximal efficiency in the design of future treatment trials.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
5R01NS050192-02
Application #
7116205
Study Section
National Institute of Neurological Disorders and Stroke Initial Review Group (NSD)
Program Officer
Janis, Scott
Project Start
2005-09-01
Project End
2008-05-31
Budget Start
2006-06-01
Budget End
2007-05-31
Support Year
2
Fiscal Year
2006
Total Cost
$666,351
Indirect Cost
Name
University of Virginia
Department
Neurology
Type
Schools of Medicine
DUNS #
065391526
City
Charlottesville
State
VA
Country
United States
Zip Code
22904
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