Cluster-Randomized Trial of Devices to Prevent Catheter-Related Bloodstream Infection

Abstract

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.

Trial registration: ClinicalTrials.gov NCT02593149.

Keywords: dialysis access; hemodialysis; hemodialysis access; vascular access.

Copyright © 2018 by the American Society of Nephrology.

Figures

Figure 1.

ClearGuard is a single-piece design that applies antimicrobial inside and outside the CVC hub versus Tego+Curos, which is a two-piece design that applies antimicrobial only to the outside of the Tego.

Figure 2.

Flow of subjects through the study. (A) Run-in and (B) intervention periods.

Figure 3.

Study results demonstrate that ClearGuard caps are superior to Tego+Curos for reducing bloodstream infection across all nine analyses. Summary of IRRs (dots) and 95% confidence intervals (whiskers), ClearGuard facilities versus Tego+Curos facilities, for (A) primary analysis and (B–I) exploratory sensitivity analyses. Estimates

Figure 4.

Each patient's at-risk time is dependent on when the patient began and ended CVC use during the study period.