Study protocol and statistical analysis plan for the 20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients after Cardiac Surgery-ll (HAS FLAIR-II) trial.

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY
Accounts of Chemical Research Pub Date : 2023-10-16 eCollection Date: 2022-12-05 DOI:10.51893/2022.4.OA1
Geoffrey Wigmore, Adam M Deane, James Anstey, Michael Bailey, Shailesh Bihari, Glenn Eastwood, Rashmi Ghanpur, Matthew J Maiden, Jeffrey J Presneill, Jaishankar Raman, Rinaldo Bellomo
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引用次数: 0

Abstract

Background: Fluid bolus therapy with 20% albumin may shorten the duration of vasopressor therapy in patients after cardiac surgery. Objective: To describe the study protocol and statistical analysis plan for the 20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients after Cardiac Surgery-II (HAS FLAIR-II) trial. Design, setting, participants and intervention: HAS FLAIR-II is a phase 2b, multicentre, parallel group, openlabel, randomised controlled trial that will be conducted at six Australian intensive care units. Patients requiring fluid bolus therapy after cardiac surgery will be randomly assigned in a 1:1 ratio to the intervention of fluid bolus therapy with 20% albumin or a comparator of fluid bolus therapy with a crystalloid solution. Main outcome measures: The primary outcome measure is the cumulative duration of vasopressor therapy. Secondary outcomes include vasopressor use, service utilisation, and mortality. All analyses will be conducted on an intention-to-treat basis. Results and conclusion: The study protocol and statistical analysis plan will guide the conduct and analysis of the HAS FLAIR-II trial, such that analytical and reporting biases are minimised. Trial registration: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN No. 12620000137998).

20%人白蛋白溶液液体丸给药治疗心脏手术后患者的研究方案和统计分析计划- ii (HAS FLAIR-II)试验
背景:20%白蛋白液体推注治疗可以缩短心脏手术后患者的血管升压治疗时间。目的:描述心脏外科II(HAS-FLAIR-II)试验后患者20%人白蛋白溶液液滴注治疗的研究方案和统计分析计划。设计、设置、参与者和干预:HAS FLAIR-II是一项2b期、多中心、平行组、开放标签、随机对照试验,将在六个澳大利亚重症监护室进行。心脏手术后需要液体推注治疗的患者将以1:1的比例随机分配到使用20%白蛋白的液体推注疗法或使用晶体溶液的液体推送疗法的对照组。主要观察指标:主要观察指标是血管升压药治疗的累计持续时间。次要结果包括使用血管升压药、服务利用率和死亡率。所有分析都将在意向治疗的基础上进行。结果和结论:研究方案和统计分析计划将指导HAS FLAIR-II试验的进行和分析,从而最大限度地减少分析和报告的偏差。试验注册:本试验已在澳大利亚-新西兰临床试验注册中心注册(ACTRN编号:12620000137998)。
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来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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