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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.

SUBMITTER: Brunelli SM

PROVIDER: S-EPMC5875956 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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

Brunelli Steven M SM Van Wyck David B DB Njord Levi L Ziebol Robert J RJ Lynch Laurie E LE Killion Douglas P DP

Journal of the American Society of Nephrology : JASN 20180222 4

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 ClearGuar ...[more]

PMID: 29472415

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Project description:According to clinical guidelines, the management of catheter-related bloodstream infections (CRBSI) due to coagulase-negative staphylococci (CoNS) includes catheter removal and antibiotic treatment for 5 to 7 days. However, in low-risk episodes, it remains uncertain whether antibiotic therapy is necessary. This randomized clinical trial aims to determine whether the non-administration of antibiotic therapy is as safe and effective as the recommended strategy in low-risk episodes of CRBSI caused by CoNS. With this purpose, a randomized, open-label, multicenter, non-inferiority clinical trial was conducted in 14 Spanish hospitals from 1 July 2019 to 31 January 2022. Patients with low-risk CRBSI caused by CoNS were randomized 1:1 after catheter withdrawal to receive/not receive parenteral antibiotics with activity against the isolated strain. The primary endpoint was the presence of any complication related to bacteremia or to antibiotic therapy within 90 days of follow-up. The secondary endpoints were persistent bacteremia, septic embolism, time until microbiological cure, and time until the disappearance of a fever. EudraCT: 2017-003612-39 INF-BACT-2017. A total of 741 patients were assessed for eligibility. Of these, 27 were included in the study; 15 (55.6%) were randomized to the intervention arm (non-antibiotic administration) and 12 (44.4%) to the control arm (antibiotic therapy as per standard practice). The primary endpoint occurred in one of the 15 patients in the intervention group (septic thrombophlebitis) and in no patients in the control group. The median time until microbiological cure was 3 days (IQR 1-3) in the intervention arm and 1.25 days (IQR 0.5-2.62) in the control arm, while the median time until fever resolution was zero days in both arms. The study was stopped due to the insufficient number of recruited patients. These results seem to indicate that low-risk CRBSI caused by CoNS can be managed without antibiotic therapy after catheter removal; efficacy and safety are not affected.

Project description:ImportanceData regarding upper extremity midline catheter (MC)-related thrombosis (CRT) are sparse, with some evidence indicating that MCs have a high rate of CRT.ObjectiveTo compare 2 MCs with differing antithrombogenic mechanisms for this outcome.Design, setting, and participantsIn this parallel, 2-arm randomized clinical trial, 496 adult patients hospitalized at a tertiary care suburban academic medical center who received an MC were assessed for eligibility between January 1, 2019, and October 31, 2020, and 212 were randomized.InterventionsInpatients were randomized to receive a 4F antithrombotic MC (MC-AT) or a 4.5F antithrombotic and antimicrobial MC (MC-AT-AM).Main outcomes and measuresThe primary outcome was symptomatic midline CRT inclusive of deep vein thrombosis or superficial venous thrombophlebitis within 30 days after insertion. Secondary outcomes included catheter-associated bloodstream infection and catheter failure.ResultsA total of 191 patients (mean [SD] age, 60.2 [16.7] years; 114 [59.7%] female) were included in the final analysis: 94 patients in the MC-AT group and 97 in the MC-AT-AM group. Symptomatic midline CRT occurred in 7 patients (7.5%) in the MC-AT group and 11 (11.3%) in the MC-AT-AM group (P = .46). Deep vein thrombosis occurred in 5 patients (5.3%) in the MC-AT group and 5 patients (5.2%) in the MC-AT-AM group (P > .99). Pulmonary embolism occurred in 1 patient in the MC-AT group. No catheter-associated bloodstream infection occurred in either group. Premature catheter failure occurred in 22 patients (23.4%) in the MC-AT group and 20 (20.6%) in the MC-AT-AM group (P = .64). In Cox proportional hazards regression analysis, no statistically significant difference was found between groups for the risk of catheter failure (hazard ratio, 1.27; 95% CI, 0.67-2.43; P = .46).Conclusions and relevanceNo difference was found in thrombosis in MCs with 2 distinct antithrombogenic mechanisms; however, the risk of CRT in both groups was high. Practitioners should strongly consider the safety risks associated with MCs when determining the appropriate vascular access device.Trial registrationClinicalTrials.gov Identifier: NCT03725293.

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

Publications

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

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