Evidence map›Paper›PMID 38785314›Full record

Trial reportInternational journal of stroke : official journal of the International Stroke Society2024

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 and 7 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of stroke : official journal of the International Stroke Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02099383 (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), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02099383 phase3completednot on this map

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

TypeinterventionalSponsorChang Gung Memorial HospitalRan2014 to 2020Enrolled244ConditionsStroke, DehydrationArmsnormal saline
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Leng Chieh LinDepartment of Emergency Medicine, Chiayi Chang Gung Memorial Hospital, Chiayi, Taiwan.
Tsong-Hai LeeStroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
Yen Chu HuangCollege of Medicine, Chang Gung University, Taoyuan, Taiwan.
Yuan Hsiung TsaiCollege of Medicine, Chang Gung University, Taoyuan, Taiwan.
Jen Tsung YangCollege of Medicine, Chang Gung University, Taoyuan, Taiwan.
Lan Yan YangBiostatistics Unit, Clinical Trial Center, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
Yu-Bin PanBiostatistics Unit, Clinical Trial Center, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
Meng LeeCollege of Medicine, Chang Gung University, Taoyuan, Taiwan.
Kuan-Fu ChenCollege of Medicine, Chang Gung University, Taoyuan, Taiwan.
Yu-Cheng HungDepartment of Emergency Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
Hsien-Hung ChengDepartment of Emergency Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.ORCID 0000-0002-9895-9898
I-Neng LeeDepartment of Medical Research and Development, Chiayi Chang Gung Memorial Hospital, Chiayi, Taiwan.
Ming Hsueh LeeDepartment of Neurosurgery, Chiayi Chang Gung Memorial Hospital, Chiayi, Taiwan.
Tefa ChiuDepartment of Emergency Medicine, China Medical University Hospital, Taichung, Taiwan.
Yeu-Jhy ChangStroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
Zhong Ning Leonard GohWesfarmers Centre for Vaccines & Infectious Diseases, Telethon Kids Institute, Perth, WA, Australia.
Chen-June SeakCollege of Medicine, Chang Gung University, Taoyuan, Taiwan.ORCID 0000-0003-0984-8385

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleEarly neurological deterioration (END) within 72 h of stroke onset is associated with poor prognosis. Optimizing hydration might reduce the risk of END.

aimsThis 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

designA 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.

resultsOverall, 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 registrationClinicalTrials.gov (NCT02099383, https://clinicaltrials.gov/study/NCT02099383).

Indexed as

Fluid TherapyIschemic StrokeAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeAcute ischemic strokeearly neurological deteriorationearly neurological improvementearly neurologic improvementhydration therapystroke etiologytime from stroke onset to treatment

Identifiers

PMID38785314
PMCPMC11528967

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.