BUN/Cr-based Hydration Therapy to Improve Outcomes for Dehydrated Patients With Acute Ischemic Stroke. (HYDO)
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|ClinicalTrials.gov Identifier: NCT02099383|
Recruitment Status : Recruiting
First Posted : March 28, 2014
Last Update Posted : June 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke Dehydration||Other: normal saline||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||244 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III Trial of BUN/Cr-based Hydration Therapy to Reduce Stroke-in-evolution and Improve Short-term Functional Outcomes for Dehydrated Patients With Acute Ischemic Stroke|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||April 2018|
Active Comparator: normal saline, bolus
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.
Other: normal saline
intravenous normal saline 20cc per kilogram of body weight over a period of 8 hours
No Intervention: normal saline, control
Patients of control group will receive intravenous normal saline 60 cc per hour.
- rate of stroke-in-evolution [ Time Frame: 72 hours ]Stroke-in-evolution is defined as a deterioration from base line in the score on the NIHSS by 4 or more points.
- rate of favorable outcome [ Time Frame: three months ]Scores of >=60 on the Barthel index, <=2 on the modified Rankin scale are considered to indicate a favorable outcome.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099383
|Contact: Leng C Lin, MD||+886 05 3621000 ext email@example.com|
|Chang Gung Memorial Hospital||Recruiting|
|Chiayi, Taiwan, 613|
|Contact: Leng C Lin, MD +886 05 3621000 ext 2805 firstname.lastname@example.org|
|Principal Investigator: Leng C Lin, MD|
|Principal Investigator:||Leng C Lin, MD||Department of Emergency Medicine, Chang Gung Memorial Hospital|