Enhanced versus standard hydration in acute ischemic stroke: REVIVE—A randomized clinical trial

Leng Chieh Lin, Tsong Hai Lee, Yen Chu Huang, Yuan Hsiung Tsai, Jen Tsung Yang, Lan Yan Yang, Yu Bin Pan, Meng Lee, Kuan Fu Chen, Yu Cheng Hung, Hsien Hung Cheng, I. Neng Lee, Ming Hsueh Lee, Tefa Chiu, Yeu Jhy Chang, Zhong Ning Leonard Goh, Chen June Seak

Research output: Contribution to journalArticlepeer-review

Abstract

Rationale: Early neurological deterioration (END) within 72 h of stroke onset is associated with poor prognosis. Optimizing hydration might reduce the risk of END. Aims: This study aimed to determine in acute ischemic stroke patients if enhanced hydration versus standard hydration reduced the incidence of major (primary) and minor (secondary) END, as well as whether it increased the incidence of early neurological improvement (secondary), at 72 h after admission Sample size estimate: A total of 244 participants per arm. Methods and design: A prospective, double-blinded, multicenter, parallel-group, randomized controlled trial conducted at four hospitals from April 2014 to July 2020, with data analyzed in August 2020. The sample size estimated was 488 participants (244 per arm). Ischemic stroke patients with measurable neurological deficits of onset within 12 h of emergency department presentation and blood urea nitrogen/creatinine (BUN/Cr) ratio ⩾ 15 at point of admission were enrolled and randomized to 0.9% sodium chloride infusions of varying rates—enhanced hydration (20 mL/kg body weight, one-third given via bolus and remainder over 8 h) versus standard hydration (60 mL/h for 8 h), followed by maintenance infusion of 40–80 mL/h for the subsequent 64 h. The primary outcome measure was the incidence of major END at 72 h after admission, defined as an increase in National Institutes of Health Stroke Scale of ⩾ 4 points from baseline. Results: Overall, 487 participants were randomized (median age 67 years; 287 females). At 72 h, 7 (2.9%) in the enhanced hydration arm and 5 (2.0%) in the standard hydration developed major END (p = 0.54). The incidence of minor END and early neurological improvement did not differ between treatment arms. Conclusion and relevance: Enhanced hydration did not reduce END or improve short-term outcomes in acute ischemic stroke. Trial Registration: ClinicalTrials.gov (NCT02099383, https://clinicaltrials.gov/study/NCT02099383)

Original languageEnglish
Pages (from-to)1010-1019
Number of pages10
JournalInternational Journal of Stroke
Volume19
Issue number9
Early online date24 May 2024
DOIs
Publication statusPublished - Oct 2024

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