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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS050192 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tight control group | Active Comparator | target glucose level 70-110 mg/dL |
|
| loose control group | Active Comparator | target glucose level 70 - 200 mg/dL |
|
| usual care group | Active Comparator | target level 70 - 300 mg/dL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV glucose insulin and potassium, GIK | Drug | The treatment intervention includes glucose, insulin, potassium infusion or standard therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemic Events | hypoglycemic events | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Favorable 3 Month Modified Rankin | 3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic Hypoglycemia | symptomatic hypoglycemia (glucose < 55 mg/dL)during treatment period | up to 5 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Johnston, MD | University of Virginia, Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Georgia | Augusta | Georgia | 30912 | United States | ||
| University of Virginia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tight Control Group | target glucose level 70-110 mg/dL |
| FG001 | Loose Control Group | target glucose level 70 - 200 mg/dL |
| FG002 | Usual Care Group | target level 70 - 300 mg/dL |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tight Control Group | target glucose level 70-110 mg/dL |
| BG001 | Loose Control Group | target glucose level 70 - 200 mg/dL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Favorable 3 Month Modified Rankin | 3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap. | Posted | Number | percentage of participants | 3 months |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen C. Johnston, MD, MSc | University of Virginia | 434 924-5323 | kj4v@virginia.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006943 | Hyperglycemia |
| D000083242 | Ischemic Stroke |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011188 | Potassium |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| standard care | Other | usual care |
|
| Charlottesville |
| Virginia |
| 22908 |
| United States |
| BG002 | Usual Care Group | target level 70 - 300 mg/dL |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Primary | Hypoglycemic Events | hypoglycemic events | Posted | Number | participants | up to 5 days |
|
|
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| Other Pre-specified | Symptomatic Hypoglycemia | symptomatic hypoglycemia (glucose < 55 mg/dL)during treatment period | Posted | Number | participants | up to 5 days |
|
|
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| Post-Hoc | Target Glucose Concentration | glucose in target range in first 24 hours | Per protocol no analysis of this endpoint was performed in the "usual care" group. | Posted | Number | participants | first 24 hours after initiation of treatment |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D008670 |
| Metals |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |