Glucose Regulation in Acute Stroke Patients (GRASP) Study

Stroke Clinical Trial

Official title: Glucose Regulation in Acute Stroke Patients (GRASP) Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperglycemia
• Stroke

• NCT number: NCT00282867
• Study type: Interventional
• Source: University of Virginia
• Status: Completed
• Phase: Phase 2
• Start date: May 2006
• Completion date: February 2009