输液套件更换间隔对导管相关血流感染（RSVP）的影响：一项随机、对照、等效性（中心静脉置管）-非劣效性（外周动脉导管）试验。
Effect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP): a randomised, controlled, equivalence (central venous access device)-non-inferiority (peripheral arterial catheter) trial.
机构信息
School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia; Infection Management Services, Nursing Practice Development Unit, and Division of Cancer Services, Princess Alexandra Hospital, Woolloongabba, QLD, Australia; Critical Care Research Group, The Prince Charles Hospital, Chermside, QLD, Australia.
School of Nursing, Midwifery and Social Work, Rural Clinical School, UQ Centre for Clinical Research, School of Medicine, The University of Queensland, QLD, Australia; School of Nursing and Midwifery, and Alliance for Vascular Access Teaching and Research, Menzies Health Institute Queensland, Griffith University, Nathan, QLD, Australia; Herston Infectious Diseases Institute, Nursing and Midwifery Research Centre, Cancer Care Services, and Intensive Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.
出版信息
Lancet. 2021 Apr 17;397(10283):1447-1458. doi: 10.1016/S0140-6736(21)00351-2.
BACKGROUND
The optimal duration of infusion set use to prevent life-threatening catheter-related bloodstream infection (CRBSI) is unclear. We aimed to compare the effectiveness and costs of 7-day (intervention) versus 4-day (control) infusion set replacement to prevent CRBSI in patients with central venous access devices (tunnelled cuffed, non-tunnelled, peripherally inserted, and totally implanted) and peripheral arterial catheters.
METHODS
We did a randomised, controlled, assessor-masked trial at ten Australian hospitals. Our hypothesis was CRBSI equivalence for central venous access devices and non-inferiority for peripheral arterial catheters (both 2% margin). Adults and children with expected greater than 24 h central venous access device-peripheral arterial catheter use were randomly assigned (1:1; stratified by hospital, catheter type, and intensive care unit or ward) by a centralised, web-based service (concealed before allocation) to infusion set replacement every 7 days, or 4 days. This included crystalloids, non-lipid parenteral nutrition, and medication infusions. Patients and clinicians were not masked, but the primary outcome (CRBSI) was adjudicated by masked infectious diseases physicians. The analysis was modified intention to treat (mITT). This study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12610000505000 and is complete.
FINDINGS
Between May 30, 2011, and Dec, 9, 2016, from 6007 patients assessed, we assigned 2944 patients to 7-day (n=1463) or 4-day (n=1481) infusion set replacement, with 2941 in the mITT analysis. For central venous access devices, 20 (1·78%) of 1124 patients (7-day group) and 16 (1·46%) of 1097 patients (4-day group) had CRBSI (absolute risk difference [ARD] 0·32%, 95% CI -0·73 to 1·37). For peripheral arterial catheters, one (0·28%) of 357 patients in the 7-day group and none of 363 patients in the 4-day group had CRBSI (ARD 0·28%, -0·27% to 0·83%). There were no treatment-related adverse events.
INTERPRETATION
Infusion set use can be safely extended to 7 days with resultant cost and workload reductions.
FUNDING
Australian National Health and Medical Research Council.
背景
预防危及生命的导管相关性血流感染（CRBSI）的最佳输液套件使用时间尚不清楚。我们旨在比较 7 天（干预组）与 4 天（对照组）更换输液套件以预防中央静脉通路装置（带隧道带套、无隧道、外周插入和完全植入）和外周动脉导管的 CRBSI 的有效性和成本。
方法
我们在澳大利亚的十家医院进行了一项随机、对照、评估者设盲试验。我们的假设是中央静脉通路装置的 CRBSI 等效性和外周动脉导管的非劣效性（两者均为 2%的边界）。预计中央静脉通路装置-外周动脉导管使用时间超过 24 小时的成人和儿童被随机分配（1:1；按医院、导管类型和重症监护病房或病房分层），通过中央化的、基于网络的服务（在分配前设盲），每 7 天或 4 天更换一次输液套件。这包括晶体液、非脂类肠外营养和药物输注。患者和临床医生未设盲，但主要结局（CRBSI）由设盲传染病医生裁决。分析采用修改后的意向治疗（mITT）。该研究在澳大利亚和新西兰临床试验注册中心（ACTRN12610000505000）注册，现已完成。
结果
在 2011 年 5 月 30 日至 2016 年 12 月 9 日期间，对 6007 名评估患者进行评估，我们将 2944 名患者分配至 7 天（n=1463）或 4 天（n=1481）输液套件更换组，其中 2941 名患者进入 mITT 分析。在中央静脉通路装置方面，1124 名患者（7 天组）中有 20 名（1.78%）和 1097 名患者（4 天组）中有 16 名（1.46%）发生 CRBSI（绝对风险差异[ARD]0.32%，95%CI-0.73 至 1.37）。在外周动脉导管方面，7 天组的 357 名患者中有 1 名（0.28%）发生 CRBSI，而 4 天组的 363 名患者中无 1 例发生 CRBSI（ARD 0.28%，-0.27%至 0.83%）。没有与治疗相关的不良事件。
解释
安全地将输液套件的使用时间延长至 7 天，可降低成本和工作负荷。
资金
澳大利亚国家卫生和医学研究委员会。
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