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
{"title":"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。","authors":"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","doi":"10.1177/17474930241259940","DOIUrl":null,"url":null,"abstract":"<p><strong>Rationale: </strong>Early neurological deterioration (END) within 72 h of stroke onset is associated with poor prognosis. Optimizing hydration might reduce the risk of END.</p><p><strong>Aims: </strong>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.</p><p><strong>Sample size estimate: </strong>A total of 244 participants per arm.</p><p><strong>Methods and design: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion and relevance: </strong>Enhanced hydration did not reduce END or improve short-term outcomes in acute ischemic stroke.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (NCT02099383, https://clinicaltrials.gov/study/NCT02099383).</p>","PeriodicalId":14442,"journal":{"name":"International Journal of Stroke","volume":null,"pages":null},"PeriodicalIF":6.3000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528967/pdf/","citationCount":"0","resultStr":"{\"title\":\"Enhanced versus standard hydration in acute ischemic stroke: REVIVE-A randomized clinical trial.\",\"authors\":\"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\",\"doi\":\"10.1177/17474930241259940\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Rationale: </strong>Early neurological deterioration (END) within 72 h of stroke onset is associated with poor prognosis. Optimizing hydration might reduce the risk of END.</p><p><strong>Aims: </strong>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.</p><p><strong>Sample size estimate: </strong>A total of 244 participants per arm.</p><p><strong>Methods and design: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion and relevance: </strong>Enhanced hydration did not reduce END or improve short-term outcomes in acute ischemic stroke.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (NCT02099383, https://clinicaltrials.gov/study/NCT02099383).</p>\",\"PeriodicalId\":14442,\"journal\":{\"name\":\"International Journal of Stroke\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":6.3000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528967/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Stroke\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17474930241259940\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/31 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Stroke","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17474930241259940","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/31 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Enhanced versus standard hydration in acute ischemic stroke: REVIVE-A randomized clinical trial.
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.
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.
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