This study is the first to provide evidence that the use of ClearGuard antimicrobial caps is associated with a decrease in the rate of CA-BSI occurrence in children receiving long-term HD. There are a multitude of factors that may contribute to the development of CA-BSIs in HD patients and attention to many of these as elements within the SCOPE HD catheter care bundles have resulted in a significant decrease in the rate of infection of SCOPE participants. To that end, while the rate of infection decreased in both the CG and NCG centers during the study period, the decrease was greatest in those centers regularly using ClearGuard caps.

Studies in long-term adult HD patients have previously provided evidence of a significant correlation between the use of ClearGuard caps and a reduction of CA-BSIs in patients using a CVC for dialysis access. Two large, multicenter studies examined the impact of ClearGuard caps by studying > 4000 patients with CVCs, spanning over 500,000 catheter days [4, 5]. Those studies overwhelmingly demonstrated a decrease in CA-BSI rates for patients utilizing ClearGuard caps versus any other type of termination cap. While replicating the adult studies in children is challenging due to the lower volume of pediatric dialysis patients, conducting this analysis within the SCOPE collaborative did make data available from 46 centers and 1786 patients with CVCs for dialysis access.

Although our study volume was low compared to the adult experience, it is important to acknowledge that the ratio of CVCs to fistulae in pediatric centers is relatively high compared to that of adult centers, making the evaluation of strategies to decrease CA-BSIs in children exceedingly important. A variety of factors contribute to the frequent use of CVCs in children including the challenges associated with placement of a fistula in a young or small patient, as well as the intention to transplant quickly and not maintain dialysis for an extended period. Due to this intentional utilization of CVCs for this patient population, it is imperative to implement practices designed to minimize the risk of CA-BSI and the associated comorbidities in these children.

All pediatric patients evaluated in this study were enrolled in the SCOPE collaborative. Achievement of a progressive decrease in the rate of CA-BSIs in HD patients via implementation of standardized infection prevention practices and care bundles remains a primary goal of the collaborative. As previously published, the SCOPE collaborative saw a decrease in CA-BSI infection rates from 3.3 to 0.8 per 100 patient months associated with increased bundle adherence between June 2013 and May 2017, among centers that provided baseline infection data between June 2012 and May 2013 [6].

The success associated with the implementation of the care bundles is in large part due to compliance with the bundle elements. Review of SCOPE data has provided evidence that over time, compliance with the SCOPE HD care bundles increased among all SCOPE centers, both those designated as CG centers and NCG centers for this study (Fig. 1). While compliance increased similarly for both groups with an associated decrease in CA-BSI rates experienced by both, the CG group showed a more significant decrease in CA-BSI rates post-CG implementation (Fig. 2). This finding suggests that CG implementation has a synergistic effect with the bundle elements on CA-BSI prevention and may, in addition, potentially protect against any bundle non-adherence.

In CG centers surveyed for this study, the initial supply cost, determined by contracting, was perceived to be higher than the cost associated with other types of termination caps for a variety of reasons, including the base cost of the caps and the fact that CG caps are not reusable (each entry into the HD line requires a new cap to be placed). However, SCOPE centers implementing the CG caps report a potential decrease in overall spending by further reducing CA-BSIs and associated hospitalizations, as well as eliminating the need for other costly antimicrobial interventions such as antimicrobial HD catheter locks. Further study of this issue will provide important cost benefit information.

As for practice changes and administrative support, it is clear that the HD population makes up a small subset of patients in a pediatric institution. The implementation of CG caps mandates that HD CVCs are cared for differently than all other central lines within a hospital system. Thus, the case for change must be very strong to outweigh the risks associated with implementing a high-risk, low-volume practice change.

There are limitations to this study, the most important being the limited number of SCOPE centers and patients who have used CG caps for more than 2 years. In addition, the data are observational. It is also possible that other unmeasured confounding factors associated with both CG centers and the reduction in CA-BSI rate explain these results. However, the availability of comparison centers that have not used CG, in addition to the experience of the SCOPE centers in collecting and submitting infection-related data and data pertaining to infection prevention activities, is a definite strength which has contributed to the success of the study.

In conclusion, this study of pediatric implementation of ClearGuard antimicrobial caps for CA-BSI prevention in children on long-term HD provides compelling evidence of an effective strategy to complement established infection prevention practices. Additional data is needed regarding the efficacy of CG caps to solidify the justification for implementation of cost and practice changes on a more widespread basis.