Objective To identify whether multifaceted interventions, or care bundles, reduce catheter related bloodstream infections (CRBSIs) from central venous catheters used for haemodialysis. Design Stepped wedge, cluster randomised design. Setting 37 renal services across Australia. Participants All adults (age ≥18 years) under the care of a renal service who required insertion of a new haemodialysis catheter. Interventions After a baseline observational phase, a service-wide, multifaceted intervention bundle that included elements of catheter care (insertion, maintenance, and removal) was implemented at one of three randomly assigned time points (12 at the first time point, 12 at the second, and 13 at the third) between 20 December 2016 and 31 March 2020. Main outcomes measure The primary endpoint was the rate of CRBSI in the baseline phase compared with intervention phase at the renal service level using the intention-to-treat principle. Results 1.14 million haemodialysis catheter days of use were monitored across 6364 patients. Patient characteristics were similar across baseline and intervention phases. 315 CRBSIs occurred (158 in the baseline phase and 157 in the intervention phase), with a rate of 0.21 per 1000 days of catheter use in the baseline phase and 0.29 per 1000 days in the intervention phase, giving an incidence rate ratio of 1.37 (95% confidence interval 0.85 to 2.21; P=0.20). This translates to one in 10 patients who undergo dialysis for a year with a catheter experiencing an episode of CRBSI. Conclusions Among patients who require a haemodialysis catheter, the implementation of a multifaceted intervention did not reduce the rate of CRBSI. Multifaceted interventions to prevent CRBSI might not be effective in clinical practice settings. Trial registration Australia New Zealand Clinical Trials Registry ACTRN12616000830493. The individual patient data generated in the trial can be shared in accordance with the trial’s data sharing policy and in accordance with the local regulatory and ethical approval for the trial. The study protocol and statistical analysis plan have already been published.

中文翻译：

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减少血液透析导管相关血流感染的多方面干预：减少阶梯楔形，整群随机试验

目的 确定多方面干预或护理包是否可以减少用于血液透析的中心静脉导管的导管相关血流感染 (CRBSI)。设计阶梯楔形，集群随机设计。在澳大利亚设立 37 个肾脏服务机构。参与者 所有需要插入新血液透析导管的在肾脏服务机构护理下的成年人（年龄≥18 岁）。干预 在基线观察阶段后，在三个随机分配的时间点之一（第一个时间点 12 个，第一个时间点 12 个，在2016 年 12 月 20 日至 2020 年 3 月 31 日期间的第二次，第三次为 13 次）。主要结果测量 主要终点是使用意向治疗原则与肾脏服务水平的干预阶段相比，基线阶段的 CRBSI 发生率。结果 对 6364 名患者的 114 万次血液透析导管使用天数进行了监测。基线和干预阶段的患者特征相似。发生 315 例 CRBSI（基线期 158 例，干预期 157 例），基线期每 1000 天导管使用率为 0.21 例，干预期每 1000 天 0.29 例，发病率比为 1.37（ 95% 置信区间 0.85 至 2.21；P=0.20）。这意味着每 10 名患者中就有 1 名接受透析一年且导管经历 CRBSI 发作。结论 在需要血液透析导管的患者中，实施多方面干预并没有降低 CRBSI 的发生率。预防 CRBSI 的多方面干预措施在临床实践环境中可能无效。试验注册澳大利亚新西兰临床试验注册 ACTRN12616000830493。试验中生成的个体患者数据可以根据试验的数据共享政策以及当地对试验的监管和伦理批准进行共享。研究方案和统计分析计划已经公布。试验中生成的个体患者数据可以根据试验的数据共享政策以及当地对试验的监管和伦理批准进行共享。研究方案和统计分析计划已经公布。试验中生成的个体患者数据可以根据试验的数据共享政策以及当地对试验的监管和伦理批准进行共享。研究方案和统计分析计划已经公布。