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 , For the HAS FLAIR-II trial investigators
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引用次数: 0
摘要
背景:20%白蛋白液体丸治疗可缩短心脏手术后患者血管加压治疗的持续时间。目的:描述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。设计、环境、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，将在澳大利亚6个重症监护病房进行。心脏手术后需要液体丸治疗的患者将按1:1的比例随机分配到20%白蛋白液体丸治疗干预组或晶体溶液液体丸治疗对照组。主要结局指标:主要结局指标是血管加压治疗的累积持续时间。次要结局包括血管加压剂使用、服务利用率和死亡率。所有分析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试验的实施和分析，以使分析和报告偏差最小化。试验注册:该试验已在澳大利亚新西兰临床试验注册中心注册(ACTRN号12620000137998)。
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
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).
期刊介绍：
ritical Care and Resuscitation (CC&R) is the official scientific journal of the College of Intensive Care Medicine (CICM). The Journal is a quarterly publication (ISSN 1441-2772) with original articles of scientific and clinical interest in the specialities of Critical Care, Intensive Care, Anaesthesia, Emergency Medicine and related disciplines.
The Journal is received by all Fellows and trainees, along with an increasing number of subscribers from around the world.
The CC&R Journal currently has an impact factor of 3.3, placing it in 8th position in world critical care journals and in first position in the world outside the USA and Europe.
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