Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT00282867
Status:
COMPLETED
Last Update Posted:
2009-08-21
First Post:
2006-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucose Regulation in Acute Stroke Patients (GRASP) Study
Sponsor:
University of Virginia
Organization:
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 \<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.
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 Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01NS050192 | NIH | None | https://reporter.nih.gov/quic… | View |