Cluster-Randomized Trial of Devices to Prevent Catheter-Related Bloodstream Infection
Cluster-Randomized Trial of Devices to Prevent Catheter-Related Bloodstream Infection
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预防导管相关血流感染装置的整群随机试验
DOI：
10.1681/asn.2017080870
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发表时间：
2018-04-01
影响因子：
13.6
通讯作者：
Killion, Douglas P.
中科院分区：
文献类型：
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作者：
Brunelli, Steven M.;Van Wyck, David B.;Killion, Douglas P.
中心静脉导管（CVC）对血流感染（BSI）的贡献不成比例，并且推而广之，对接受透析的患者的感染相关住院、死亡率和医疗保健费用的贡献不成比例。最近的产品进步可能会减少BSI，但需要一个足够有力的比较有效性研究，以促进循证患者护理决策。在一项为期13个月的前瞻性、随机分组、开放标签试验中，我们比较了使用ClearGuard HD抗菌屏障帽（ClearGuard组）的机构与使用Tego血液透析连接器+Curos消毒帽（Tego+Curos组）的机构的BSI发生率。根据BSI率、使用CVC的患者数量和地理位置对美国的40家DaVita透析机构进行配对，然后按1：1进行分组随机化。我们招募了在这些机构接受CVC透析的所有成年患者，对肝素或氯己定过敏的患者除外。总体而言，1671名患者参与了研究，累积> 183，000个CVC-天。研究结果是阳性血培养（PBC）率作为BSI率的指标。我们在集群水平上计算结果，并对设施集群效应进行了调整。在研究干预前3个月的导入期内，两组的BSI发生率相似（P=0.8）。在随后的13个月干预期间，ClearGuard组的BSI发生率显著低于Tego+Curos组（分别为0.28 vs 0.75 PBMC/1000 CVC-天; P=0.001）。未报告器械相关不良事件。总之，与Tego连接器加Curos帽相比，ClearGuard HD抗菌屏障帽显著降低了使用CVC进行血液透析的患者中导管相关BSI的发生率，这代表了血液透析患者护理的重要进步。
Central venous catheters (CVCs) contribute disproportionately to bloodstream infection (BSI) and, by extension, to infection-related hospitalization, mortality, and health care costs in patients undergoing dialysis. Recent product advancements may reduce BSIs, but a sufficiently powered comparative-effectiveness study is needed to facilitate evidence-based patient care decisions. In a 13-month, prospective, cluster-randomized, open-label trial, we compared BSI rates in facilities using ClearGuard HD antimicrobial barrier caps (ClearGuard group) with those in facilities using Tego hemodialysis connectors plus Curos disinfecting caps (Tego+Curos group). Forty DaVita dialysis facilities in the United States were pair-matched by BSI rate, number of patients using CVCs, and geographic location, and then cluster randomized 1:1. We enrolled all adult patients undergoing dialysis with CVCs at these facilities, except those allergic to heparin or chlorhexidine. Overall, 1671 patients participated in the study, accruing >183,000 CVC-days. The study outcome was positive blood culture (PBC) rate as an indicator of BSI rate. We calculated results at the cluster level and adjusted for the facility cluster effect. During a 3-month run-in period immediately before study interventions, the groups had similar BSI rates (P=0.8). During the 13-month intervention period that immediately followed, the ClearGuard group had a BSI rate significantly lower than that of the Tego+Curos group (0.28 versus 0.75 PBCs per 1000 CVC-days, respectively; P=0.001). No device-related adverse events were reported. In conclusion, compared with Tego connectors plus Curos caps, ClearGuard HD antimicrobial barrier caps significantly lowered the rate of catheter-related BSIs in patients undergoing hemodialysis using CVCs, representing an important advancement in hemodialysis patient care.