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The investigators' preliminary findings suggest that providing patients with acute ischemic stroke hydration therapy on the basis of their presenting BUN/Cr ratio may help reduce the occurrence of stroke-in-evolution(SIE) and therefore improve prognosis.
The trial will be carried out in two parts. Part 1 assesses the rate of stroke-in-evolution 72 hours after the onset of stroke as a measure of the activity of BUN/Cr ratio based hydration therapy. Part 2, The investigators use two outcome measures, including Barthel index, and modified Rankin scale for neurological evaluation to assess whether BUN/Cr ratio based hydration therapy results in sustained clinical benefit at three months.
The investigators have recently reported a novel finding that the blood urea nitrogen (BUN)/creatinine (Cr) ratio, a marker of hydration status, was an independent predictor of SIE among patients who had suffered acute ischemic stroke. The investigators found that patients who had a BUN/Cr ratio ≥ 15 were 3.4-fold more likely to experience SIE than patients who had a BUN/Cr ratio < 15. The ratio of SIE was 13.9% in all patients, with 20% in patients who had a BUN/Cr ratio ≥ 15 and 8.3% in patients who had a BUN/Cr ratio < 15. Among the patients presenting with acute ischemic stroke, 37% of them had a BUN/Cr ratio ≥ 15.
The investigators' recent pilot study was designed to determine if providing hydration therapy, specifically intravenous saline infusion, to patients with a blood urea nitrogen/creatinine ratio (BUN/Cr) ≥15 reduces the occurrence of SIE after acute ischemic stroke. Patients in the hydration group received a significantly larger (all P < 0.001) median volume of infused saline than patients in the control group. And this allowed 82% of the patients to maintain their BUN/Cr ratio <15 in first 8 hours. The proportion of patients who experienced SIE was significantly lower in the hydration group compared with the control group.
Dehydration, as indicated by an increased BUN/Cr ratio, is known to be relatively common among patients who have experienced stroke. According to the result of our pilot study, a hydration strategy with intravenous 20 cc per kilogram of body weight normal saline in first 8 hours was safe and effective to prevent dehydration related early neurological deterioration.
In this study, the investigators conduct a randomized double-blind control trial to test the hypothesis that whether BUN/Cr ratio based hydration therapy has clinical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal saline, bolus | Active Comparator | Patients of study group will receive intravenous normal saline 20cc per kilogram of body weight, one third of which will be given as a bolus followed by delivery of the remaining two third as a constant infusion over a period of 8 hours. |
|
| normal saline, control | No Intervention | Patients of control group will receive intravenous normal saline 60 cc per hour. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal saline | Other | intravenous normal saline 20cc per kilogram of body weight over a period of 8 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of stroke-in-evolution | Stroke-in-evolution is defined as a deterioration from base line in the score on the NIHSS by 4 or more points. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| rate of favorable outcome | Scores of >=60 on the Barthel index, <=2 on the modified Rankin scale are considered to indicate a favorable outcome. | three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leng C Lin, MD | Department of Emergency Medicine, Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Chiayi City | 613 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20825831 | Background | Lin LC, Yang JT, Weng HH, Hsiao CT, Lai SL, Fann WC. Predictors of early clinical deterioration after acute ischemic stroke. Am J Emerg Med. 2011 Jul;29(6):577-81. doi: 10.1016/j.ajem.2009.12.019. Epub 2010 Apr 2. | |
| 38785314 | Derived | Lin LC, Lee TH, Huang YC, Tsai YH, Yang JT, Yang LY, Pan YB, Lee M, Chen KF, Hung YC, Cheng HH, Lee IN, Lee MH, Chiu T, Chang YJ, Goh ZNL, Seak CJ. Enhanced versus standard hydration in acute ischemic stroke: REVIVE-A randomized clinical trial. Int J Stroke. 2024 Oct;19(9):1010-1019. doi: 10.1177/17474930241259940. Epub 2024 Jul 31. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |