Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282867
Status:
COMPLETED
Last Update Posted:
2009-08-21
First Post:
2006-01-26
Brief Title:
Glucose Regulation in Acute Stroke Patients GRASP Study
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Glucose Regulation in Acute Stroke Patients GRASP Study
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 300mgdL 2 the tight control GIK plus meal insulin group with a target of 110mgdL or 3 the loose control GIK plus meal insulin group with a target of 200mgdL-with all groups avoiding glucose levels of 70mgdL
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
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 300mgdL 2 the tight control GIK plus meal insulin group with a target of 110mgdL or 3 the loose control GIK plus meal insulin group with a target of 200mgdL-with all groups avoiding glucose levels of 70mgdL
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS050192 | NIH | None | httpsreporternihgovquickSearchR01NS050192 |