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 : Unknown
Verified July 2016 by Chang Gung Memorial Hospital.
Recruitment status was: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099383
|Contact: Leng C Lin, MD||+886 05 3621000 ext firstname.lastname@example.org|
|Chang Gung Memorial Hospital||Recruiting|
|Chiayi, Taiwan, 613|
|Contact: Leng C Lin, MD +886 05 3621000 ext 2805 email@example.com|
|Principal Investigator: Leng C Lin, MD|
|Principal Investigator:||Leng C Lin, MD||Department of Emergency Medicine, Chang Gung Memorial Hospital|