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.

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. FUNDING: Australian National Health and Medical Research Council.

Risk factors for arterial catheter failure and complications during critical care hospitalisation: a secondary analysis of a multisite, randomised trial.

OBJECTIVES: Arterial catheters (ACs) are critical for haemodynamic monitoring and blood sampling but are prone to complications. We investigated the incidence and risk factors of AC failure. METHODS: Secondary analysis of a multi-centre randomised controlled trial (ACTRN 12610000505000). Analysis included a subset of adult intensive care unit patients with an AC. The primary outcome was all-cause device failure. Secondary outcomes were catheter associated bloodstream infection (CABSI), suspected CABSI, occlusion, thrombosis, accidental removal, pain, and line fracture. Risk factors associated with AC failure were investigated using Cox proportional hazards and competing-risk models. RESULTS: Of 664 patients, 173 (26%) experienced AC failure (incidence rate [IR] 37/1000 catheter days). Suspected CABSI was the most common failure type (11%; IR 15.3/1000 catheter days), followed by occlusion (8%; IR 11.9/1,000 catheter days), and accidental removal (4%; IR 5.5/1000 catheter days). CABSI occurred in 16 (2%) patients. All-cause failure and occlusion were reduced with ultrasound-assisted insertion (failure: adjusted hazard ratio [HR] 0.43, 95% CI 0.25, 0.76; occlusion: sub-HR 0.11, 95% CI 0.03, 0.43). Increased age was associated with less AC failure (60-74 years HR 0.63, 95% CI 0.44 to 0.89; 75 + years HR 0.36, 95% CI 0.20, 0.64; referent 15-59 years). Females experienced more occlusion (adjusted sub-HR 2.53, 95% CI 1.49, 4.29), while patients with diabetes had less (SHR 0.15, 95% CI 0.04, 0.63). Suspected CABSI was associated with an abnormal insertion site appearance (SHR 2.71, 95% CI 1.48, 4.99). CONCLUSIONS: AC failure is common with ultrasound-guided insertion associated with lower failure rates. Trial registration Australian New Zealand Clinical Trial Registry (ACTRN 12610000505000); date registered: 18 June 2010.

Incidence and risk factors for central venous access device failure in hospitalized adults: A multivariable analysis of 1892 catheters.

BACKGROUND: Central venous access devices (CVADs) allow intravenous therapy, haemodynamic monitoring and blood sampling but many fail before therapy completion. OBJECTIVE: To quantify CVAD failure and complications; and identify risk factors. DESIGNS, SETTINGS AND PARTICIPANTS: Secondary analysis of multicentre randomised controlled trial including patients aged ≥16 years with a non-tunnelled CVAD (NTCVAD), peripherally-inserted central catheter (PICC) or tunnelled CVAD (TCVAD). Primary outcome was incidence of all-cause CVAD failure (central line-associated bloodstream infection [CLABSI], occlusion, accidental dislodgement, catheter fracture, thrombosis, pain). Secondary outcomes were CLABSI, occlusion and dislodgement. Cox regression was used to report time-to-event associations. RESULTS: In 1892 CVADs, all-cause failure occurred in 10.2% of devices: 49 NTCVADs (6.1%); 100 PICCs (13.2%); 44 TCVADs (13.4%). Failure rates for CLABSI, occlusion and dislodgement were 5.3%, 1.8%, and 1.7%, respectively. Independent CLABSI predictors were blood product administration through PICCs (hazard ratio (HR) 2.62, 95% confidence interval (CI) 1.24-5.55); and in TCVADs, one or two lumens, compared with three to four (HR 3.36, 95%CI 1.68-6.71), intravenous chemotherapy (HR 2.96, 95%CI 1.31-6.68), and diabetes (HR 3.25, 95%CI 1.40-7.57). Independent factors protective for CLABSI include antimicrobial NTCVADs (HR 0.23, 95%CI 0.08-0.63) and lipids in TCVADs (HR 0.32, 95%CI 0.14-0.72). NTCVADs inserted at another hospital (HR 7.06, 95%CI 1.48-33.7) and baseline infection in patients with PICCs (HR 2.72, 95%CI 1.08-6.83) were predictors for dislodgement. No independent occlusion predictors were found. Modifiable risk factors were identified for CVAD failure, which occurred for 1-in-10 catheters. Strict infection prevention measures and improved CVAD securement could reduce CLABSI and dislodgement risk.

Intravascular device administration sets: replacement after standard versus prolonged use in hospitalised patients-a study protocol for a randomised controlled trial (The RSVP Trial).

INTRODUCTION: Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3-4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload. METHODS AND ANALYSIS: This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant. ETHICS AND DISSEMINATION: Relevant ethical approvals have been received. CONSORT Statement recommendations will be used to guide preparation of any publication. Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trial Registry (ACTRN 12610000505000).