澳大利亚昆士兰大学Claire M Rickard团队研究了输液器更换间隔对导管相关血流感染的影响。2021年4月17日，该研究发表在《柳叶刀》杂志上。

使用输液器预防危及生命的导管相关血流感染（CRBSI）的最佳持续时间尚不清楚。为了比较7天（干预）和4天（对照）更换输液器预防中心静脉通路装置和外周动脉导管患者CRBSI的有效性和成本，研究组在10家澳大利亚医院进行了一项随机、对照、评估者盲的试验。

研究组假设中心静脉导管的CRBSI等价，而外周动脉导管的CRBSI非劣效（均为2%边缘）。招募预期使用中心静脉导管超过24小时的成人和儿童，将其按1：1随机分配，每7天或4天更换一次输液器，包括晶体、非脂质肠外营养和药物输注。分析采用改良意向治疗法（mITT）。

2011年5月30日至2016年12月9日，研究组对6007名患者进行了评估，将2944名患者随机分组，其中1463例7天更换一次输液器，1481例4天更换一次，mITT分析包括2941名患者。

对于中心静脉通路装置，7天组的1124例患者中有20例（1.78%）出现CRBSI，4天组的1097例患者中有16例（1.46%），绝对风险差为0.32%。对于外周动脉导管，7天组357例患者中有1例（0.28%）出现CRBSI，4天组363例患者中无一例出现CRBSI，绝对风险差为0.28%。无治疗相关的不良事件。

研究结果表明，输液器的使用可安全延长到7天，从而降低成本和工作量。

附：英文原文

Title: 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

Author: Claire M Rickard, Nicole M Marsh, Emily N Larsen, Matthew R McGrail, Nicholas Graves, Naomi Runnegar, Joan Webster, Amanda Corley, David McMillan, John R Gowardman, Debbie A Long, John F Fraser, Fenella J Gill, Jeanine Young, Marghie Murgo, Evan Alexandrou, Md Abu Choudhury, Raymond J Chan, Nicole C Gavin, Azlina Daud, Annamaria Palermo, Adrian Regli, E Geoffrey Playford

Issue&Volume: 2021/04/17

Abstract:

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.

DOI: 10.1016/S0140-6736(21)00351-2

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00351-2/fulltext