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What is the best catheter lock solution in preventing catheter-related blood infections? A protocol for a Bayesian network meta-analysis of randomised controlled trials.

ABSTRACT: INTRODUCTION:Catheter-related bloodstream infection (CRBSI) is a major complication after central venous catheter insertion, which is associated with significant morbidity, mortality and additional medical costs. Many lock solutions for CRBSI have been evaluated. However, using traditional pairwise meta-analyses to summarise the evidence does not allow the inclusion of data from treatments that have not been compared head to head, which could impact the precision of pooled estimates in a meta-analysis. Therefore, we evaluated the efficacy and safety of the different lock solutions for CRBSI through a network meta-analysis. METHODS AND ANALYSIS:The primary outcome of this network meta-analysis is the CRBSI. The secondary outcomes are exit-site infection and catheter-related thrombosis. We will search the PubMed, Embase, Web of Science and the Cochrane Library databases for recent relevant meta-analysis and their reference lists to include randomised controlled trials (RCTs) that compared lock solutions for CRBSI prevention. Two individuals will independently extract data from each included RCT according to a predesigned Excel spreadsheet and will assess the methodological quality using the Cochrane risk of bias tool. We will analyse the data using WinBUGS (V.1.4.3) and Stata (V.15.0). We will also estimate the pooled direct and indirect effects for all lock solutions using the network meta-analysis. ETHICS AND DISSEMINATION:As the present meta-analysis is performed based on previous published studies, no ethical approval and patient safety considerations are required. This study commenced on 18 January 2019, and its expected completion date is 1 December 2019. We will disseminate the results of our network meta-analysis through an international peer-reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42019121089.

SUBMITTER: Dang F

PROVIDER: S-EPMC6609037 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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What is the best catheter lock solution in preventing catheter-related blood infections? A protocol for a Bayesian network meta-analysis of randomised controlled trials.

Dang Fangping F Li Huiju H Tian Jinhui J Wang Ruijuan R Ren Jingjie J

BMJ open 20190628 6

<h4>Introduction</h4>Catheter-related bloodstream infection (CRBSI) is a major complication after central venous catheter insertion, which is associated with significant morbidity, mortality and additional medical costs. Many lock solutions for CRBSI have been evaluated. However, using traditional pairwise meta-analyses to summarise the evidence does not allow the inclusion of data from treatments that have not been compared head to head, which could impact the precision of pooled estimates in a ...[more]

PMID: 31256039

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Project description:IntroductionCentral venous access devices (CVADs) are commonly used for the treatment of paediatric cancer patients. Catheter locking is a routine intervention that prevents CVAD-associated adverse events, such as infection, occlusion and thrombosis. While laboratory and clinical data are promising, tetra-EDTA (T-EDTA) has yet to be rigorously evaluated or introduced in cancer care as a catheter lock.Methods and analysisThis is a protocol for a two-arm, superiority type 1 hybrid effectiveness-implementation randomised controlled trial conducted at seven hospitals across Australia and New Zealand. Randomisation will be in a 3:2 ratio between the saline (heparinised saline and normal saline) and T-EDTA groups, with randomly varied blocks of size 10 or 20 and stratification by (1) healthcare facility; (2) CVAD type and (3) duration of dwell since insertion. Within the saline group, there will be a random allocation between normal and heparin saline. Participants can be re-recruited and randomised on insertion of a new CVAD. Primary outcome for effectiveness will be a composite of CVAD-associated bloodstream infections (CABSI), CVAD-associated thrombosis or CVAD occlusion during CVAD dwell or at removal. Secondary outcomes will include CABSI, CVAD-associated-thrombosis, CVAD failure, incidental asymptomatic CVAD-associated-thrombosis, other adverse events, health-related quality of life, healthcare costs and mortality. To achieve 90% power (alpha=0.05) for the primary outcome, data from 720 recruitments are required. A mixed-methods approach will be employed to explore implementation contexts from the perspective of clinicians and healthcare purchasers.Ethics and disseminationEthics approval has been provided by Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (HREC/22/QCHQ/81744) and the University of Queensland HREC (2022/HE000196) with subsequent governance approval at all sites. Informed consent is required from the substitute decision-maker or legal guardian prior to participation. In addition, consent may also be obtained from mature minors, depending on the legislative requirements of the study site. The primary trial and substudies will be written by the investigators and published in peer-reviewed journals. The findings will also be disseminated through local health and clinical trial networks by investigators and presented at conferences.Trial registration numberACTRN12622000499785.

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.

Project description:BackgroundThere is no ideal lock solution that prevents hemodialysis (HD) catheter loss due to catheter-related thrombosis (CRT) and catheter-related bloodstream infection (CRBSI). Catheter loss is associated with increased hospitalization and high inpatient costs. Sodium bicarbonate (NaHCO3) demonstrates anti-infective and anticoagulation properties with a good safety profile, making it an ideal lock solution development target.The objective of this study was to determine the safety and efficacy of using sodium bicarbonate catheter lock solution (SBCLS) as a means of preventing HD catheter loss due to CRT and CRBSI.MethodsThe study took place in a community hospital in Brooklyn, NY, USA. All admitted patients ≥18 years of age who needed HD treatment through CVC were included in the study. 451 patients included in the study were provided SBCLS or NSCLS post-dialysis. Catheter loss due to CRT or CRBSI was evaluated over a period of 546 days.ResultsA total of 452 patients met the criteria; 1 outlier was excluded, 226 were in the NSCLS group and 225 were in the SBCLS group. There were no significant differences between groups in comorbidities at the outset. The NSCLS group had CRT and CRBSI rates of 4.1 and 2.6/1000 catheter days (CD), respectively, compared with 0.17/1000 CD for both outcomes in the SBCLS group. SBCLS patients had a significantly reduced catheter loss rate due to CRT (P < 0.0001) and CRBSI (P = 0.0004). NSCLS patients had higher odds of losing their catheter due to CRT {odds ratio [OR] 26.6 [95% confidence interval (CI) 3.57-198.52]} and CRBSI [OR 15.9 (95% CI 2.09-121.61)] during the study period.ConclusionThe novel approach of using SBCLS was found to be safe and was statistically superior to normal saline in preventing HD catheter loss due to CRT and CRBSI. NaHCO3 solution is inexpensive, readily available in various settings and holds the potential to decrease hospitalization, length of stay and dialysis-related costs.Trial registrationMaimonides Medical Center Investigational Review Board, Study IRB 2015-06-25-CIH. ClinicalTrials.gov identifier: NCT03627884.

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:Despite advances in infection prevention and control, catheter-associated urinary tract infections (CAUTIs) are common and remain problematic. A number of measures can be taken to reduce the risk of CAUTI in hospitals. Appropriate urinary catheter insertion procedures are one such method. Reducing bacterial colonisation around the meatal or urethral area has the potential to reduce CAUTI risk. However, evidence about the best antiseptic solutions for meatal cleaning is mixed, resulting in conflicting recommendations in guidelines internationally. This paper presents the protocol for a study to evaluate the effectiveness (objective 1) and cost-effectiveness (objective 2) of using chlorhexidine in meatal cleaning prior to catheter insertion, in reducing catheter-associated asymptomatic bacteriuria and CAUTI.A stepped wedge randomised controlled trial will be undertaken in three large Australian hospitals over a 32-week period. The intervention in this study is the use of chlorhexidine (0.1%) solution for meatal cleaning prior to catheter insertion. During the first 8?weeks of the study, no hospital will receive the intervention. After 8?weeks, one hospital will cross over to the intervention with the other two participating hospitals crossing over to the intervention at 8-week intervals respectively based on randomisation. All sites complete the trial at the same time in 2018. The primary outcomes for objective 1 (effectiveness) are the number of cases of CAUTI and catheter-associated asymptomatic bacteriuria per 100 catheter days will be analysed separately using Poisson regression. The primary outcome for objective 2 (cost-effectiveness) is the changes in costs relative to health benefits (incremental cost-effectiveness ratio) from adoption of the intervention.Results will be disseminated via peer-reviewed journals and presentations at relevant conferences.A dissemination plan it being developed. Results will be published in the peer review literature, presented at relevant conferences and communicated via professional networks.Ethics approval has been obtained.12617000373370, approved 13/03/2017. Protocol version 1.1.

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What is the best catheter lock solution in preventing catheter-related blood infections? A protocol for a Bayesian network meta-analysis of randomised controlled trials.

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What is the best catheter lock solution in preventing catheter-related blood infections? A protocol for a Bayesian network meta-analysis of randomised controlled trials.

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