NCT02099383

BUN/Cr-based Hydration Therapy to Improve Outcomes for Dehydrated Patients With Acute Ischemic Stroke.

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stroke
• Dehydration

Interventions

Type	Name	Description
OTHER	normal saline	intravenous normal saline 20cc per kilogram of body weight over a period of 8 hours

Timeline

• Start date: 2014-04-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2014-03-28
• Last updated: 2021-09-08

Locations

1 site across 1 country: Taiwan