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Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial.

ABSTRACT: Catheter-related bloodstream infection (CRBSI) results in significant attributable morbidity and mortality. In this randomized, double-blind, placebo-controlled trial, we studied the efficacy and safety of a daily ethanol lock for the prevention of CRBSI in patients with a tunnelled central venous catheter (CVC).From 2005 through 2008, each lumen of the CVC of adult hematology patients was locked for 15 minutes per day with either 70%-ethanol or placebo, where after the lock solution was flushed through. As a primary endpoint, the incidence rates of endoluminal CRBSI were compared.The intent-to-treat analysis was based on 376 patients, accounting for 448 CVCs and 27,745 catheter days. For ethanol locks, the incidence of endoluminal CRBSI per 1000 CVC-days was 0.70 (95%-CI, 0.4-1.3), compared to 1.19 (95% confidence interval, 0.7-1.9) for placebo (incidence rate-ratio, 0.59; 95% confidence interval, 0.27-1.30; P = .19). For endoluminal CRBSI according to the strictest definition (positive hub culture and identical bacterial strain in blood), a 3.6-fold, non-significant, reduction was observed for patients receiving ethanol (2 of 226 versus 7 of 222; P = .103). No life-threatening adverse events were observed. More patients receiving ethanol discontinued lock-therapy (11 of 226 versus 1 of 222; P = .006) or continued with decreased lock-frequency (10 of 226 versus 0 of 222; P = .002), due to non-severe adverse events.In this study, the reduction in the incidence of endoluminal CRBSI using preventive ethanol locks was non-significant, although the low incidence of endoluminal CRBSI precludes definite conclusions. Therefore, the lack of statistical significance may partially reflect a lack of power. Significantly more patients treated with ethanol locks discontinued their prophylactic treatment due to adverse effects, which were non-severe but reasonably ethanol related. Additional studies should be performed in populations with higher incidence of (endoluminal) CRBSI. Alternative sources of bacteremia, like exoluminal CRBSI or microbial translocation during chemotherapy-induced mucositis may have been more important in our patients.ClinicalTrials.gov NCT00122642.

SUBMITTER: Slobbe L

PROVIDER: S-EPMC2877107 | biostudies-literature | 2010 May

REPOSITORIES: biostudies-literature

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Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial.

Slobbe Lennert L Doorduijn Jeanette K JK Lugtenburg Pieternella J PJ El Barzouhi Abdelilah A Boersma Eric E van Leeuwen Willem B WB Rijnders Bart J A BJ

PloS one 20100526 5

<h4>Background</h4>Catheter-related bloodstream infection (CRBSI) results in significant attributable morbidity and mortality. In this randomized, double-blind, placebo-controlled trial, we studied the efficacy and safety of a daily ethanol lock for the prevention of CRBSI in patients with a tunnelled central venous catheter (CVC).<h4>Methodology</h4>From 2005 through 2008, each lumen of the CVC of adult hematology patients was locked for 15 minutes per day with either 70%-ethanol or placebo, wh ...[more]

PMID: 20520776

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Project description: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.

Project description:BackgroundTunnelled dialysis catheter (TC) infections are a major health complication and are associated with increased antibiotic consumption, hospital stays, health costs and mortality. Experimental data provide evidence that Ethenox, a mixture of enoxaparine 1000 U/mL in 40% v/v ethanol, could be a promising lock solution. The aim of the study is to compare an interdialytic lock solution of Ethenox with reference lock solutions, unfractionated heparin (UFH) or citrate 4% for the prevention of TCI in hemodialysis patients.MethodThis study will monitor a multicentre, prospective, single blind, randomized, controlled, parallel group trial. The main inclusion criteria are patients > 18 years old with end-stage renal disease, treated with chronic hemodialysis/hemodiafiltration three times a week, with incident or prevalent non-impregnated internal jugular TCs inserted for at least 2 weeks and able to give informed consent. Exclusion criteria are TCI in the previous 4 weeks and anti-infective treatment for TCI in the previous 2 weeks. Patients will be randomized to receive either study treatment Ethenox in the intervention group or reference solutions in the control group, unfractionated heparin (UFH) or citrate 4% w/v according to usual practice. The primary outcome measure will be time to first TCIs assessed by an endpoint adjudication committee blinded to the study arm according to predefined criteria. Patients will receive the study treatment for up to 12 months. Intention-to-treat analysis of the primary endpoint will be performed with a marginal Cox proportional hazard model. Prospective power calculations indicate that the study will have 90% statistical power to detect a clinical significant two-fold increase in median infection-free survival if 200 patients are recruited into each arm over a period of 24 months.DiscussionFirm evidence of the efficacy of the Ethenox lock in preventing TCI could be of major clinical benefit for patients. The results of this study will allow the development of new guidelines based on a high level of evidence.Trial registrationClinicalTrials.gov Identifier: NCT03083184 , date of registration March 17 2017 and European Clinical Trials Database Identifier: EudraCT 2016-A00180-51), date of registration July 11 2016.

Project description:ObjectivesWe aimed to compare the success rates and other catheter-related parameters between peripherally inserted central catheters (PICCs) and non-tunnelled ultrasound-guided central venous catheters (USG-CVCs) including femoral, jugular, brachiocephalic and subclavian lines.DesignThis was a retrospective observational study.SettingThe study was performed in a level III neonatal intensive care unit (NICU) in Qatar, as a single-site study.ParticipantsThis study included 1333 neonates who required CVC insertion in the NICU from January 2016 to December 2018. Of those, we had 1264 PICCs and 69 non-tunnelled USG-CVCs.Outcome measuresThe success rate and other catheter-related complications in the two groups.ResultsThe overall success rate was 88.4% in the USG-CVCs (61/69) compared with 90% in the PICCs (1137/1264) group (p=0.68). However, the first prick success rate was 69.4% in USG-CVCs (43/69) compared with 63.6% in the PICCs (796/1264) group. Leaking and central line-associated blood stream infection (CLABSI) were significantly higher in the USG-CVC group compared with the PICC group (leaking 16.4% vs 2.3%, p=0.0001) (CLABSI 8.2% vs 3.1%, p=0.03). CLABSI rates in the PICC group were 1.75 per 1000 catheter days in 2016 and 3.3 in 2017 compared with 6.91 in 2016 (p=0.0001) and 14.32 in 2017 (p=0.0001) for the USG-CVCs. USG-CVCs had to be removed due to catheter-related complications in 52.5% of the cases compared with 29.9% in PICCs, p=0.001. In 2018, we did not have any non-tunnelled USG-CVCs insertions in our NICU.ConclusionsThe overall complication rate, CLABSI and leaking are significantly higher in non-tunnelled USG-CVCs compared with the PICCs. However, randomised controlled trials with larger sample sizes are desired. Proper central venous device selection and timing, early PICC insertion and early removal approach, dedicated vascular access team development, proper central venous line maintenance, central line simulation workshops and US-guided insertions are crucial elements for patient safety in NICU.

Project description:BackgroundCatheter-related bloodstream infections (CRBSIs) are a significant cause of morbidity and mortality in critically ill patients, contributing to prolonged hospital stays and increased costs. Whether taurolidine lock solutions (TLS) are beneficial for the prevention of CRBSIs remains controversial. In this meta-analysis, we aim to assess the efficacy of TLS for preventing CRBSIs.MethodsWe conducted a systematic search of PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials. Eligible studies included randomized controlled trials that reported on the effects of TLS for preventing CRBSIs. The primary outcome in these studies was catheter-related bloodstream infections, with microbial distribution of CRBSI and catheter-associated thrombosis as secondary outcomes. Data were combined using random-effects models owing to significant clinical heterogeneity.ResultsSix randomized controlled trials (RCTs) conducted from 2004 through 2013 involving 431 patients and 86,078 catheter-days were included in the review. TLS were significantly associated with a lower incidence of CRBSIs when compared to heparin lock solutions (Risk Ratio [RR], 0.34; 95% Confidence Interval [CI], 0.21-0.55). Use of TLS significantly decreased the incidence of CRBSIs from gram-negative (G-) bacteria (P = 0.004; RR, 0.27; CI, 0.11-0.65), and was associated with a non-significant decrease in gram-positive (G+) bacterial infections (P = 0.07; RR, 0.41; CI, 0.15-1.09). No significant association was observed with TLS and catheter-associated thrombosis (RR, 1.99; CI, 0.75-5.28).ConclusionsThe use of TLS reduced the incidence of CRBSIs without obvious adverse effects or bacterial resistance. However, the susceptibility of G+ and G- bacteria to taurolidine and the risk for catheter-associated thrombosis of TLS are indeterminate due to limited data. The results should be treated with caution due to the limited sample sizes and methodological deficiencies of included studies. Therefore, additional well-designed and adequately powered RCTs are needed to confirm these findings.

Dataset Information

Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial.

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Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial.

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