The CATERPILLAR study: an assessor-blinded randomized controlled trial comparing a taurolidine–citrate–heparin lock solution to a heparin-only lock solution for the prevention of central-line-associated bloodstream infections in paediatric oncology patients

IF 3.9 3区医学 Q1 INFECTIOUS DISEASES

Journal of Hospital Infection Pub Date : 2024-07-14 DOI:10.1016/j.jhin.2024.06.009

C.H. van den Bosch , Y.G.T. Loeffen , A.F.W. van der Steeg , J.T. van der Bruggen , F.N.J. Frakking , M. Fiocco , C.P. van de Ven , M.H.W.A. Wijnen , M.D. van de Wetering

{"title":"The CATERPILLAR study: an assessor-blinded randomized controlled trial comparing a taurolidine–citrate–heparin lock solution to a heparin-only lock solution for the prevention of central-line-associated bloodstream infections in paediatric oncology patients","authors":"C.H. van den Bosch , Y.G.T. Loeffen , A.F.W. van der Steeg , J.T. van der Bruggen , F.N.J. Frakking , M. Fiocco , C.P. van de Ven , M.H.W.A. Wijnen , M.D. van de Wetering","doi":"10.1016/j.jhin.2024.06.009","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Taurolidine–citrate(–heparin) lock solutions (TCHL) are suggested as a promising and safe method for the prevention of central-line-associated bloodstream infections (CLABSI).</p></div><div><h3>Aim</h3><p>To investigate the efficacy of TCHL for the prevention of CLABSI in paediatric oncology patients.</p></div><div><h3>Methods</h3><p>An assessor-blinded randomized controlled trial at the Princess Máxima Centre for paediatric oncology, the Netherlands, was performed from 2020 to 2023. Paediatric oncology patients receiving a tunnelled central venous access device (CVAD) were eligible. A total of 462 patients were required to compare the TCHL to the heparin-only lock (HL). Patients were followed-up for the first 90 days after CVAD insertion. The primary outcome was the incidence of the first CLABSI from CVAD insertion until the end of follow-up. Intention-to-treat and per-protocol analyses were performed.</p></div><div><h3>Findings</h3><p>In total, 232 were randomized in the HL and 231 in the TCHL group. A total of 47 CLABSIs were observed. The intention-to-treat analysis showed that a CLABSI was observed in 26 (11.2%) of the HL group patients versus 21 (9.1%) of the TCHL group patients; incidence rate ratio (IRR) of 0.81 (95% confidence interval (CI): 0.46–1.45) in favour of the TCHL group. The per-protocol analysis showed that a CLABSI was observed in 10 (7.9%) of the HL group patients versus 6 (4.8%) of the TCHL group patients; IRR of 0.59 (95% CI: 0.21–1.62) in favour of the TCHL group. Adverse events were more common in the TCHL group but rarely reported.</p></div><div><h3>Conclusion</h3><p>No difference was detected between the TCHL and HL in the incidence of CLABSI in paediatric oncology patients.</p></div>","PeriodicalId":54806,"journal":{"name":"Journal of Hospital Infection","volume":"152 ","pages":"Pages 56-65"},"PeriodicalIF":3.9000,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0195670124002287/pdfft?md5=ea1161093e087c424a0fd9e57878159d&pid=1-s2.0-S0195670124002287-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Hospital Infection","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0195670124002287","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Taurolidine–citrate(–heparin) lock solutions (TCHL) are suggested as a promising and safe method for the prevention of central-line-associated bloodstream infections (CLABSI).

Aim

To investigate the efficacy of TCHL for the prevention of CLABSI in paediatric oncology patients.

Methods

An assessor-blinded randomized controlled trial at the Princess Máxima Centre for paediatric oncology, the Netherlands, was performed from 2020 to 2023. Paediatric oncology patients receiving a tunnelled central venous access device (CVAD) were eligible. A total of 462 patients were required to compare the TCHL to the heparin-only lock (HL). Patients were followed-up for the first 90 days after CVAD insertion. The primary outcome was the incidence of the first CLABSI from CVAD insertion until the end of follow-up. Intention-to-treat and per-protocol analyses were performed.

Findings

In total, 232 were randomized in the HL and 231 in the TCHL group. A total of 47 CLABSIs were observed. The intention-to-treat analysis showed that a CLABSI was observed in 26 (11.2%) of the HL group patients versus 21 (9.1%) of the TCHL group patients; incidence rate ratio (IRR) of 0.81 (95% confidence interval (CI): 0.46–1.45) in favour of the TCHL group. The per-protocol analysis showed that a CLABSI was observed in 10 (7.9%) of the HL group patients versus 6 (4.8%) of the TCHL group patients; IRR of 0.59 (95% CI: 0.21–1.62) in favour of the TCHL group. Adverse events were more common in the TCHL group but rarely reported.

Conclusion

No difference was detected between the TCHL and HL in the incidence of CLABSI in paediatric oncology patients.

查看原文本刊更多论文

CATERPILLAR 研究：一项评估者盲法随机对照试验，比较了妥洛尼定-柠檬酸肝素锁定溶液和纯肝素锁定溶液在预防儿科肿瘤患者中心静脉相关血流感染方面的效果。

背景：目的：研究 TCHL 对预防儿科肿瘤患者 CrLABSI 的疗效：荷兰玛西玛公主儿童肿瘤中心于 2020-2023 年开展了一项评估者盲法随机对照试验。接受隧道式中心静脉通路装置（CVAD）治疗的儿童肿瘤患者均符合条件。共需要 462 名患者对 TCHL 和纯肝素锁（HL）进行比较。患者在插入 CVAD 后的前 90 天接受随访。主要结果是自插入 CVAD 至随访结束期间首次 CLABSI 的发生率。进行了意向治疗分析和按协议分析：HL 组和 TCHL 组分别共有 232 人和 231 人接受随机治疗。共观察到 47 例 CLABSI。意向治疗分析结果显示，HL 组患者中有 26 例（11.2%）出现 CLABSI，而 TCHL 组患者中有 21 例（9.1%）；TCHL 组患者的发病率比为 0.81（CI95% 0.46-1.45）。按协议分析显示，HL 组患者中有 10 例（7.9%）观察到 CLABSI，而 TCHL 组患者中只有 6 例（4.8%）观察到 CLABSI；TCHL 组患者的 IRR 为 0.59（CI95% 0.21-1.62）。不良事件在TCHL组更为常见，但很少有报告：结论：在儿科肿瘤患者的CLABSI发生率方面，TCHL组与HL组之间没有差异：试验注册号：ClinicalTrials.gov NCT05740150。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of Hospital Infection 医学-传染病学

CiteScore

12.70

自引率

5.80%

发文量

271

审稿时长

19 days

期刊介绍： The Journal of Hospital Infection is the editorially independent scientific publication of the Healthcare Infection Society. The aim of the Journal is to publish high quality research and information relating to infection prevention and control that is relevant to an international audience. The Journal welcomes submissions that relate to all aspects of infection prevention and control in healthcare settings. This includes submissions that: provide new insight into the epidemiology, surveillance, or prevention and control of healthcare-associated infections and antimicrobial resistance in healthcare settings; provide new insight into cleaning, disinfection and decontamination; provide new insight into the design of healthcare premises; describe novel aspects of outbreaks of infection; throw light on techniques for effective antimicrobial stewardship; describe novel techniques (laboratory-based or point of care) for the detection of infection or antimicrobial resistance in the healthcare setting, particularly if these can be used to facilitate infection prevention and control; improve understanding of the motivations of safe healthcare behaviour, or describe techniques for achieving behavioural and cultural change; improve understanding of the use of IT systems in infection surveillance and prevention and control.