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Our prior studies demonstrated that dehydration was a predictor for poor outcome in stroke and Blood urea nitrogen/Cr ratio-based saline hydration therapy in patients with acute ischemic stroke may increase the rate of favorable clinical outcome with functional independence at 3 months after stroke. However, dehydration is likely to be only a part of representation in poor nutrition status and physical fragility for a stroke patient.
Our prior study found that acute stroke patients admitted to neurological intensive care unit with low urinary creatinine excretion rate (CER), a marker of muscle mass, was associated with poor outcome at 6 months after stroke. An animal study suggested inadequate food and water intake determine mortality following stroke in mice and nutritional support reduced the 14-day mortality rate from 59% to 15%. A study also showed that high protein intake was associated with a better outcome in previous cardiovascular events.
We will calculate CER based on published equation. Based on our prior study, acute stroke patients with their CER<1500 mg/day will be enrolled. A randomized controlled trial will be conducted and patients will be randomly assigned to high protein diet or normal protein diet for at least 2 weeks. We plan to enroll 300 patients, with 150 patients in ach group, during 3-year study period. We will consult dietitians for arrangement of their diet. We assume that patients receiving high protein diet will have higher opportunity to walk independently (modified Rankin Scale 0-1) at 3 month after stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High protein diet | Experimental | received high protein diet, prescribed by dietitian |
|
| Normal protein diet | Active Comparator | received normal protein diet, prescribed by dietitian |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high protein diet | Dietary Supplement | receive 1.8g protein/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale 0-1 | No significant disability | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale 0-2 | Slight disability | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital, Chiayi Branch | Chiayi City | 613 | Taiwan |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| normal protein diet |
| Dietary Supplement |
receive 1g protein/kg |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |