This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The GRASP study is an NIH-NINDS funded, multi-center, randomized, controlled, unblinded (blinded outcomes) trial that will examine the feasibility and safety of insulin infusion therapy in hyperglycemic acute ischemic stroke patients.
The specific aims are: 1) to collect preliminary data on the safety and feasibility of IV GIK plus meal insulin for treatment of hyperglycemia (>110 mg/dL) in acute ischemic stroke patients.We hypothesize that the GIK treated groups will have <=15% greater frequency of hypoglycemic events compared to the control group. We hypothesize that the GIK treated groups will have >60% of subjects within the target plasma glucose level within 24 hours of treatment initiation.2) to collect preliminary data comparing IV GIK therapy plus meal insulin with a target plasma glucose level of 70-110 mg/dL (tight) to a target plasma glucose level of 70-200 mg/dL (loose) to a control group for treatment of hyperglycemia in ischemic stroke. We hypothesize that the tight control GIK group will have fewer poor outcomes, as measured by 5 different outcome measures, at 3 months compared to the control group and loose control GIK group and that these data will provide preliminary information to advance the design of future trials. Subjects with acute ischemic stroke and glucose level greater than 110 mg/dL will be eligible if treatment can be started within 2 hours of established eligibility and within 24 hours of symptoms onset. A total of 80 subjects will be assigned to usual care, loose control (target glucose level 70 - 200 mg/dL) or tight control (70 -110 mg/dL).
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