强化与标准水化治疗急性缺血性脑卒中的效果比较：REVIVE 随机临床试验。
Enhanced versus standard hydration in acute ischemic stroke: REVIVE-A randomized clinical trial.
机构信息
Department of Emergency Medicine, Chiayi Chang Gung Memorial Hospital, Chiayi, Taiwan.
Shu-Zen Junior College of Medicine and Management, Kaohsiung, Taiwan.
出版信息
Int J Stroke. 2024 Oct;19(9):1010-1019. doi: 10.1177/17474930241259940. Epub 2024 Jul 31.
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).
背景
卒中发病后 72 小时内的早期神经功能恶化（END）与不良预后相关。优化水合作用可能会降低 END 的风险。
目的
本研究旨在确定在急性缺血性卒中患者中，强化水化治疗与标准水化治疗相比，是否会降低入院后 72 小时主要（一级）和次要（二级）END 的发生率，以及是否会增加早期神经功能改善（二级）的发生率。
样本量估计
每组 244 名参与者。
方法和设计
这是一项前瞻性、双盲、多中心、平行组、随机对照试验，于 2014 年 4 月至 2020 年 7 月在四家医院进行，数据于 2020 年 8 月进行分析。估计的样本量为 488 名参与者（每组 244 名）。符合以下条件的缺血性卒中患者入组并随机分为两组：在急诊科就诊后 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 的患者，接受不同速度的 0.9%氯化钠输注，分别为强化水化（20mL/kg 体重，三分之一快速推注，其余在 8 小时内输注）和标准水化（8 小时内 60mL/h），随后在接下来的 64 小时内维持 40-80mL/h 的输注。主要结局指标为入院后 72 小时主要 END 的发生率，定义为与基线相比 NIHSS 评分增加 ⩾ 4 分。
结果
总体而言，487 名患者被随机分配（中位年龄 67 岁；287 名女性）。在 72 小时时，强化水化组有 7 例（2.9%）和标准水化组有 5 例（2.0%）发生主要 END（p=0.54）。治疗组之间的次要 END 和早期神经功能改善的发生率没有差异。
结论和相关性
强化水化治疗并未降低急性缺血性卒中患者的 END 发生率或改善短期结局。
试验注册
ClinicalTrials.gov（NCT02099383，https://clinicaltrials.gov/study/NCT02099383）。
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