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Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial
2021
Hickman-type tunnelled catheters (Hickman), peripherally inserted central catheters (PICCs), and totally implanted ports (PORTs) are used to deliver systemic anticancer treatment (SACT) via a central vein. We aimed to compare complication rates and costs of the three devices to establish acceptability, clinical effectiveness, and cost-effectiveness of the devices for patients receiving SACT.
We did an open-label, multicentre, randomised controlled trial (Cancer and Venous Access [CAVA]) of three central venous access devices: PICCs versus Hickman (non-inferiority; 10% margin); PORTs versus Hickman (superiority; 15% margin); and PORTs versus PICCs (superiority; 15% margin). Adults (aged ≥18 years) receiving SACT (≥12 weeks) for solid or haematological malignancy from 18 oncology units in the UK were included. Four randomisation options were available: Hickman versus PICCs versus PORTs (2:2:1), PICCs versus Hickman (1:1), PORTs versus Hickman (1:1), and PORTs versus PICCs (1:1). Randomisation was done using a minimisation algorithm stratifying by centre, body-mass index, type of cancer, device history, and treatment mode. The primary outcome was complication rate (composite of infection, venous thrombosis, pulmonary embolus, inability to aspirate blood, mechanical failure, and other) assessed until device removal, withdrawal from study, or 1-year follow-up. This study is registered with ISRCTN, ISRCTN44504648.
Between Nov 8, 2013, and Feb 28, 2018, of 2714 individuals screened for eligibility, 1061 were enrolled and randomly assigned, contributing to the relevant comparison or comparisons (PICC vs Hickman n=424, 212 [50%] on PICC and 212 [50%] on Hickman; PORT vs Hickman n=556, 253 [46%] on PORT and 303 [54%] on Hickman; and PORT vs PICC n=346, 147 [42%] on PORT and 199 [58%] on PICC). Similar complication rates were observed for PICCs (110 [52%] of 212) and Hickman (103 [49%] of 212). Although the observed difference was less than 10%, non-inferiority of PICCs was not confirmed (odds ratio [OR] 1·15 [95% CI 0·78–1·71]) potentially due to inadequate power. PORTs were superior to Hickman with a complication rate of 29% (73 of 253) versus 43% (131 of 303; OR 0·54 [95% CI 0·37–0·77]). PORTs were superior to PICCs with a complication rate of 32% (47 of 147) versus 47% (93 of 199; OR 0·52 [0·33–0·83]).
For most patients receiving SACT, PORTs are more effective and safer than both Hickman and PICCs. Our findings suggest that most patients receiving SACT for solid tumours should receive a PORT within the UK National Health Service.
UK National Institute for Health Research Health Technology Assessment Programme.
Journal Article
Sustained reduction of catheter-associated bloodstream infections with enhancement of catheter bundle by chlorhexidine dressings over 11 years
2019
Background
Prospective randomized controlled studies have demonstrated that addition of chlorhexidine (CHG) dressings reduces the rate of catheter (central venous and arterial)-associated bloodstream infections (CABSIs). However, studies confirming their impact in a real-world setting are lacking.
Methods
We conducted a real-world data study evaluating the impact of incrementally introducing chlorhexidine dressings (sponge or gel) in addition to an ongoing catheter bundle on the rates of CABSI, expressed as incidence density rates per 1000 catheter-days measured as part of a surveillance program. Poisson regression models were used to compare infection rates over time. Both dressings were used simultaneously during one of the five study periods.
Results
From 2006 to 2014, 18,286 patients were admitted (91,292 ICU-days and 155,242 catheter-days). We recorded 111 CABSIs. We observed a progressive but significant decrease of CABSI rates from 1.48 (95% CI 1.09–2.01) without CHG dressings to 0.69 (95% CI 0.43–1.09) and 0.23 (95% CI 0.11–0.48) episodes per 1000 catheter-days when CHG sponge and CHG gel dressings were used (
p
= 0.0007;
p
< 0.001). A non-significant lower rate of infections occurred with CHG gel compared with CHG sponge dressings. An identical low rate of allergic skin reactions (0.3/1000 device-days) was observed with both types of CHX dressings. Post-study data until 2018 confirmed a sustained decrease of infection rates over 11 years.
Conclusions
The addition of chlorhexidine dressings to all CVC and arterial lines to an ongoing catheter bundle was associated with a sustained 11-year reduction of all catheter-associated bloodstream infections. This large real-world data study further supports the current recommendations for the systematic use of CHG dressings on all catheters of ICU patients.
Journal Article
A Comparison of Peripherally Inserted Central Catheter Materials
2025
New catheter materials for peripherally inserted central catheters (PICCs) may reduce the risk of device failure due to infectious, thrombotic, and catheter occlusion events. However, data from randomized trials comparing these catheters are lacking.
We conducted a randomized, controlled, superiority trial in three Australian tertiary hospitals. Adults and children who were referred for PICC placement were assigned in a 1:1:1 ratio to receive a hydrophobic or chlorhexidine PICC or a standard polyurethane PICC and were followed for 8 weeks. The primary outcome was device failure, which was a composite of infectious (bloodstream or local) or noninfectious (thrombosis, breakage, or occlusion) complications.
A total of 1098 participants underwent randomization; 365 were assigned to the hydrophobic group, 365 to the chlorhexidine group, and 368 to the standard-polyurethane group. Device failure occurred in 21 of 358 participants (5.9%) in the hydrophobic group, in 36 of 363 (9.9%) in the chlorhexidine group, and in 22 of 359 (6.1%) in the standard-polyurethane group (risk difference, hydrophobic vs. standard polyurethane, -0.2 percentage points [95% confidence interval {CI}, -3.7 to 3.2; P = 0.89]; and chlorhexidine vs. standard polyurethane, 3.8 percentage points [95% CI, -0.1 to 7.8; P = 0.06]). In the hydrophobic group as compared with the standard-polyurethane group, the odds ratio for device failure was 0.96 (95% CI, 0.51 to 1.78), and in the chlorhexidine group as compared with the standard-polyurethane group, the odds ratio was 1.71 (95% CI, 0.98 to 2.99). Complications from any cause during the period of PICC placement occurred in 77 participants (21.5%) in the hydrophobic group, in 140 (38.6%) in the chlorhexidine group, and in 78 (21.7%) in the standard-polyurethane group (odds ratio, hydrophobic vs. standard polyurethane, 0.99 [95% CI, 0.69 to 1.42]; and chlorhexidine vs. standard polyurethane, 2.35 [95% CI, 1.68 to 3.29]). No adverse events were attributable to the interventions.
Among adults and children who were referred for PICC placement, the risk of device failure due to noninfectious or infectious complications was not lower with hydrophobic or chlorhexidine PICCs than with standard polyurethane PICCs. (Funded by the National Health and Medical Research Council of Australia; PICNIC Australian New Zealand Clinical Trials Registry number, ACTRN12619000022167.).
Journal Article
P226 Nerve catheter disconnections: do they need to be resited?
2025
Background and AimsNerve catheter infusions for perioperative and post trauma analgesia are increasingly common. Catheter disconnection predominantly leads to removal of the catheter, which could lead to increased pain, and the need to resite. We reviewed our local anaesthetic nerve catheter infusion database to identify patients with catheter disconnections and catheter outcomes.MethodsRetrospective review was performed of the pain service infusion catheter database from April 2023 to August 2024, identifying patients with witnessed or unwitnessed catheter disconnection. Electronic notes were reviewed to identify the location of disconnection, outcome of catheter, subsequent bacteraemia or catheter colonisation.Results69 (7.1%) Catheters were blocked, dislodged, pulled out or disconnected. 21 unwitnessed disconnections, 1 witnessed disconnection. 22 catheter disconnections (2.25%) from a total 974 inserted followed up between April 2023-August 2024. 5 in critical care, 1 in recovery, 16 on wards. All catheters except a witnessed disconnection were removed. 2 were resited on same day, 2 resited following day, and 19 catheters not resited. 15/22 tips not sent, 3 no growth, 4 tip positive, no bacteraemia identified, (6/22) had blood cultures sent.Abstract P226 Figure 1Catbeter outcome after disconnection[Image Omitted. See PDF.]Abstract P226 Figure 2Nerve catheter disconnection rates[Image Omitted. See PDF.]Abstract P226 Figure 3Catheter disconnection cause[Image Omitted. See PDF.]ConclusionsThe disconnection rates are reassuringly low at our institution. The current default is removing any nerve catheter that is disconnected. This could lead to increased pain, and usage of emergency anaesthetic time and operative space. There is little evidence to guide practice, except for central neuraxial catheter practice. Majority of catheter disconnections are between catheter and filter. Theoretically bulk flow of pathogens down a catheter that is disconnected would be low. We propose to wrap catheter in sterile gauze, stop infusion and refer for pain team/on call anaesthetist review for consideration of disinfecting end of catheter, cutting back with sterile scissors and reattaching with new filter. One should still employ strategies to minimise disconnection in the first place.
Journal Article
P318 Sciatic catheter placed under direct vision. A case report
2025
Application for ESRA Abstract Prizes:Background and AimsOncologic surgery of the musculoskeletal system is frequently aggressive and associated with significant postoperative pain. These procedures often involve atypical tumor locations, which may necessitate unusual surgical approaches. As a result, the placement of peripheral nerve catheters can be limited, particularly when the standard insertion site lies within the surgical field. Alternative strategies must be considered to ensure adequate analgesia in the postoperative period.MethodsWe present the case of an 18-year-old male who underwent an en bloc resection of a peroneal Ewing’s sarcoma involving both bone and adjacent soft tissues. The surgical incision extended across the lower third of the lateral compartment of the leg, precluding the standard placement of a popliteal nerve catheter. Additionally, the patient’s anatomy presented challenges to more proximal catheter placement using conventional ultrasound-guided techniques. To overcome these limitations, the surgical team opted for intraoperative placement of a peripheral nerve catheter under direct vision prior to wound closure. This approach ensured accurate positioning while avoiding contamination of the surgical field.ResultsThe patient retained the catheter for seven days postoperatively, during which he experienced excellent pain control (Visual Analog Scale <3), with only one transient episode of higher pain (VAS 6) that responded to a morphine bolus. No complications related to the catheter were observed. The patient was discharged on postoperative day 10 without incident.ConclusionsIn conclusion, we suggest that intraoperative placement of peripheral nerve catheters by the surgical team may be a safe and effective alternative when standard approaches are contraindicated or technically challenging.
Journal Article
Multifaceted intervention to reduce haemodialysis catheter related bloodstream infections: REDUCCTION stepped wedge, cluster randomised trial
2022
AbstractObjectiveTo identify whether multifaceted interventions, or care bundles, reduce catheter related bloodstream infections (CRBSIs) from central venous catheters used for haemodialysis.DesignStepped wedge, cluster randomised design.Setting37 renal services across Australia.ParticipantsAll adults (age ≥18 years) under the care of a renal service who required insertion of a new haemodialysis catheter.InterventionsAfter a baseline observational phase, a service-wide, multifaceted intervention bundle that included elements of catheter care (insertion, maintenance, and removal) was implemented at one of three randomly assigned time points (12 at the first time point, 12 at the second, and 13 at the third) between 20 December 2016 and 31 March 2020.Main outcomes measureThe primary endpoint was the rate of CRBSI in the baseline phase compared with intervention phase at the renal service level using the intention-to-treat principle.Results1.14 million haemodialysis catheter days of use were monitored across 6364 patients. Patient characteristics were similar across baseline and intervention phases. 315 CRBSIs occurred (158 in the baseline phase and 157 in the intervention phase), with a rate of 0.21 per 1000 days of catheter use in the baseline phase and 0.29 per 1000 days in the intervention phase, giving an incidence rate ratio of 1.37 (95% confidence interval 0.85 to 2.21; P=0.20). This translates to one in 10 patients who undergo dialysis for a year with a catheter experiencing an episode of CRBSI.ConclusionsAmong patients who require a haemodialysis catheter, the implementation of a multifaceted intervention did not reduce the rate of CRBSI. Multifaceted interventions to prevent CRBSI might not be effective in clinical practice settings.Trial registrationAustralia New Zealand Clinical Trials Registry ACTRN12616000830493.
Journal Article
STANDARDIZATION OF IVAD FLUSHING PROTOCOLS TO A SALINE-ONLY APPROACH IN A LARGE HEALTH SYSTEM
2025
Significance & Background: Implanted vascular access devices (IVAD) are commonly used in the oncology patient population to administer anti-neoplastic therapy, supportive care medications, hydrations and transfusions. Maintaining port patency and blood return is essential both during and in between treatments. Many healthcare systems across the US have transitioned to saline only flushes as the standard for post administration and maintenance of IVADs. The Cleveland Clinic health system transitioned away from heparin lock flush years ago with an exception for IVADs. Purpose: This health system utilizes multiple IVAD devices, encompassing valve technology and open-ended catheters. Identifying the kind of port and previous flushing protocols can be challenging, with heparin lock flush used for certain IVADs and saline-only for others. The aim of this initiative is to unify the flushing and upkeep procedures for IVADs throughout the extensive health system. Interventions: A review of literature was conducted, and evidence was found to support a practice chance. A Cochrane review found no evidence to support the use of heparin being superior to normal saline (Zhong et al., 2017). The flushing protocol was standardized to Standardized IVAD flush to 20 ml normal saline using the pulsatile/turbulent flow method prior to deaccess and every 12 weeks for maintenance. Enterprise protocols were moved through approval bodies, nursing education completed, the change was rolled out on January 1, 2024. Results: The implementation of the standardized adjustment to saline-only flush for all IVADs has been effective for close to nine months, with no indications of a rise in catheter blockages. Additionally, since this change was put into practice, monitoring of alteplase usage shows no signs of increased occurrence of catheter occlusions or greater use of alteplase. Discussion: A number of systematic reviews and retrospective analyses indicate that normal saline (NS) is just as effective as heparin in maintaining the patency of central lines with port systems (Egnatios & Gloria, 2021; Klein et al., 2018; Regina de Silva et al., 2021; Zhong et al., 2017). Complications such as bleeding, allergic responses, and thrombocytopenia are associated with heparin use (López-Briz et al., 2018). The findings of this project further corroborate the adoption of a saline-only pulsatile flushing protocol as a standard practice for IVADs.
Journal Article
Randomized Controlled Trial of Chlorhexidine Dressing and Highly Adhesive Dressing for Preventing Catheter-related Infections in Critically Ill Adults
by
Zahar, Jean-Ralph
,
Mimoz, Olivier
,
Arrault, Xavier
in
Adhesives
,
Adhesives - administration & dosage
,
Adhesives - adverse effects
2012
Abstract
Rationale
Most vascular catheter-related infections (CRIs) occur extraluminally in patients in the intensive care unit (ICU). Chlorhexidine-impregnated and strongly adherent dressings may decrease catheter colonization and CRI rates.
Objectives
To determine if chlorhexidine-impregnated and strongly adherent dressings decrease catheter colonization and CRI rates.
Methods
In a 2:1:1 assessor-masked randomized trial in patients with vascular catheters inserted for an expected duration of 48 hours or more in 12 French ICUs, we compared chlorhexidine dressings, highly adhesive dressings, and standard dressings from May 2010 to July 2011. Coprimary endpoints were major CRI with or without catheter-related bloodstream infection (CR-BSI) with chlorhexidine versus nonchlorhexidine dressings and catheter colonization rate with highly adhesive nonchlorhexidine versus standard nonchlorhexidine dressings. Catheter-colonization, CR-BSIs, and skin reactions were secondary endpoints.
Measurements and Main Results
A total of 1,879 patients (4,163 catheters and 34,339 catheter-days) were evaluated. With chlorhexidine dressings, the major-CRI rate was 67% lower (0.7 per 1,000 vs. 2.1 per 1,000 catheter-days; hazard ratio [HR], 0.328; 95% confidence interval [CI], 0.174–0.619; P = 0.0006) and the CR-BSI rate 60% lower (0.5 per 1,000 vs. 1.3 per 1,000 catheter-days; HR, 0.402; 95% CI, 0.186–0.868; P = 0.02) than with nonchlorhexidine dressings; decreases were noted in catheter colonization and skin colonization rates at catheter removal. The contact dermatitis rate was 1.1% with and 0.29% without chlorhexidine. Highly adhesive dressings decreased the detachment rate to 64.3% versus 71.9% (P < 0.0001) and the number of dressings per catheter to two (one to four) versus three (one to five) (P < 0.0001) but increased skin colonization (P < 0.0001) and catheter colonization (HR, 1.650; 95% CI, 1.21–2.26; P = 0.0016) without influencing CRI or CR-BSI rates.
Conclusions
A large randomized trial demonstrated that chlorhexidine-gel–impregnated dressings decreased the CRI rate in patients in the ICU with intravascular catheters. Highly adhesive dressings decreased dressing detachment but increased skin and catheter colonization.
Clinical trial registered with www.clinicaltrials.gov (NCT01189682).
Journal Article
Routine versus clinically indicated replacement of peripheral intravenous catheters: a randomised controlled equivalence trial
2012
Summary Background The millions of peripheral intravenous catheters used each year are recommended for 72–96 h replacement in adults. This routine replacement increases health-care costs and staff workload and requires patients to undergo repeated invasive procedures. The effectiveness of the practice is not well established. Our hypothesis was that clinically indicated catheter replacement is of equal benefit to routine replacement. Methods This multicentre, randomised, non-blinded equivalence trial recruited adults (≥18 years) with an intravenous catheter of expected use longer than 4 days from three hospitals in Queensland, Australia, between May 20, 2008, and Sept 9, 2009. Computer-generated random assignment (1:1 ratio, no blocking, stratified by hospital, concealed before allocation) was to clinically indicated replacement, or third daily routine replacement. Patients, clinical staff, and research nurses could not be masked after treatment allocation because of the nature of the intervention. The primary outcome was phlebitis during catheterisation or within 48 h after removal. The equivalence margin was set at 3%. Primary analysis was by intention to treat. Secondary endpoints were catheter-related bloodstream and local infections, all bloodstream infections, catheter tip colonisation, infusion failure, catheter numbers used, therapy duration, mortality, and costs. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12608000445370. Findings All 3283 patients randomised (5907 catheters) were included in our analysis (1593 clinically indicated; 1690 routine replacement). Mean dwell time for catheters in situ on day 3 was 99 h (SD 54) when replaced as clinically indicated and 70 h (13) when routinely replaced. Phlebitis occurred in 114 of 1593 (7%) patients in the clinically indicated group and in 114 of 1690 (7%) patients in the routine replacement group, an absolute risk difference of 0·41% (95% CI −1·33 to 2·15%), which was within the prespecified 3% equivalence margin. No serious adverse events related to study interventions occurred. Interpretation Peripheral intravenous catheters can be removed as clinically indicated; this policy will avoid millions of catheter insertions, associated discomfort, and substantial costs in both equipment and staff workload. Ongoing close monitoring should continue with timely treatment cessation and prompt removal for complications. Funding Australian National Health and Medical Research Council.
Journal Article
Administration of taurolidine-citrate lock solution for prevention of central venous catheter infection in adult neutropenic haematological patients: a randomised, double-blinded, placebo-controlled trial (TAURCAT)
by
Carratalà, J.
,
Montero, I.
,
Arnan, M.
in
Anti-Infective Agents - administration & dosage
,
Anti-Infective Agents - adverse effects
,
Antibiotic lock technique
2018
Background
Catheter-related bloodstream infection (CRBSI) is one of the most frequent complications in patients with cancer who have central venous catheters (CVCs) implanted and is associated with substantial morbidity and mortality. Taurolidine is a non-antibiotic agent with broad-spectrum antimicrobial activity, which has been used as a lock solution to prevent CRBSI in some settings. However, little is known about its usefulness in high-risk adult neutropenic patients with cancer. This prospective randomised clinical trial aims to test the hypothesis that taurolidine-citrate lock solution is more effective than placebo for preventing catheter infection in neutropenic haematological patients.
Methods
This study is a prospective, multicentre, randomised, double-blinded, parallel, superiority, placebo-controlled trial. Patients with haematological cancer who are expected to develop prolonged neutropenia (> 7 days) and who have a non-tunnelled CVC implanted will be randomised to receive prophylactic taurolidine-citrate-heparin solution using a lock technique (study group) or heparin alone (placebo group). The primary endpoint will be bacterial colonisation of the CVC hubs. The secondary endpoints will be the incidence of CRBSI, CVC removal, adverse events, and 30-day case-fatality rate.
Discussion
The lock technique is a preventive strategy that inhibits bacterial colonisation in the catheter hubs, which is the initial step of endoluminal catheter colonisation and the development of infection. Taurolidine is a nontoxic agent that does not develop antibiotic resistance because it acts as an antiseptic rather than an antibiotic. Taurolidine has shown controversial results in the few trials conducted in cancer patients. These studies have important limitations due to the lack of data on adult and/or high-risk neutropenic patients, the type of catheters studied (tunnelled or ports), and the lack of information regarding the intervention (e.g. dwelling of the solution, time, and periodicity of the lock technique). If our hypothesis is proven, the study could provide important solid evidence on the potential usefulness of this preventive procedure in a population at high risk of CRBSI, in whom this complication may significantly impair patient outcome.
Trial registration
ISRCTN,
ISRCTN47102251
. Registered on 9 September 2015.
Journal Article