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

IF 6.3 2区医学 Q1 CLINICAL NEUROLOGY International Journal of Stroke Pub Date : 2024-10-01 Epub Date: 2024-07-31 DOI:10.1177/17474930241259940

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

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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).

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急性缺血性脑卒中患者加强水合与标准水合的对比：REVIVE - 随机临床试验。

理由：卒中发生后 72 小时内的早期神经功能恶化 (END) 与预后不良有关。目的：确定急性缺血性脑卒中患者入院 72 小时后，加强水化与标准水化相比是否能降低主要（主要）和次要（次要）END 的发生率，以及是否能增加早期神经功能改善（次要）的发生率：前瞻性、双盲、多中心、平行组、随机对照试验，2014 年 4 月至 2020 年 7 月在 4 家医院进行，2020 年 8 月分析数据。样本量估计为 488 人（每组 244 人）。缺血性脑卒中患者在急诊科就诊 12 小时内出现可测量的神经功能缺损，且入院时血尿素氮/肌酐 (BUN/Cr) 比值≥15，这些患者被纳入试验并随机接受不同速率的 0.9% 氯化钠输注--加强型水合（20 毫升/千克体重，三分之一为栓剂输注，其余在 8 小时内输注）与标准型水合（60 毫升/小时，持续 8 小时），随后 64 小时内维持 40-80 毫升/小时的输注。主要结果指标是入院 72 小时后早期严重神经功能恶化的发生率，即美国国立卫生研究院卒中量表比基线增加≥4 分：487名参与者接受了随机治疗（中位年龄67岁；287名女性）。72小时后加强补液组中有 7 人（2.9%）出现严重早期神经功能恶化，标准补液组中有 5 人（2.0%）出现严重早期神经功能恶化（P=0.54）。轻微早期神经功能恶化和早期神经功能改善的发生率在不同治疗组之间没有差异：试验注册：试验注册：ClinicalTrials.gov (NCT02099383, https://clinicaltrials.gov/study/NCT02099383)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Stroke 医学-外周血管病

CiteScore

13.90

自引率

6.00%

发文量

132

审稿时长

6-12 weeks

期刊介绍： The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.