Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands
Department of Pediatric Infectious Diseases and Immunology, UMC Utrecht, Utrecht, The Netherlands.
BMJ Open. 2023 Mar 21;13(3):e069760. doi: 10.1136/bmjopen-2022-069760.
The efficacy of taurolidine containing lock solutions for the prevention of central line-associated bloodstream infections (CLABSI) in paediatric oncology patients is still unknown. If the taurolidine-citrate-heparin lock appears to decrease the incidence of CLABSIs, we hope to increase the quality of life of children with cancer by subsequently reducing the central venous access device (CVAD)-removal rates, dispense of antibiotics, hospital admissions and incidence of severe sepsis resulting in intensive care unit admission.
This assessor-blinded randomised controlled trial including 462 patients was designed to compare the taurolidine-citrate-heparin lock to the heparin-only lock for the prevention of CLABSIs in paediatric oncology patients. Patients receiving their first CVAD at the Princess Máxima Centre for Paediatric Oncology, Utrecht, the Netherlands, are eligible for inclusion. The primary outcome of this study is the incidence of first CLABSIs from CVAD insertion until the end of the study, maximum follow-up of 90 days. An intention-to-treat and a per-protocol analysis will be performed. An interim analysis will be performed after the inclusion of 50% of the patients. The results of the interim analysis and overall conduct of the trial will be discussed by a data safety monitoring board.
The medical ethics committee NedMec, Utrecht, the Netherlands, has approved this research (number 20/370). Written informed consent for participation in this trial and publication of the trial data is obtained from all patients and/or their parents/guardians. The results of this trial will be published in a peer-reviewed journal and the data will be made available on reasonable request after publication of the main results manuscript.
NTR6688; NCT05740150.
含牛磺酸盐的锁溶液在儿科肿瘤患者中预防中心静脉相关血流感染（CLABSI）的疗效尚不清楚。如果牛磺酸盐-柠檬酸盐-肝素锁似乎能降低 CLABSI 的发生率，我们希望通过随后降低中心静脉通路装置（CVAD）的移除率、减少抗生素的使用、住院和严重败血症的发生率，从而提高癌症患儿的生活质量，导致重症监护病房入院。
这项评估者盲法随机对照试验纳入了 462 名患者，旨在比较牛磺酸盐-柠檬酸盐-肝素锁与肝素单独锁在预防儿科肿瘤患者 CLABSI 中的作用。在荷兰乌得勒支 Princess Máxima 儿科肿瘤中心接受首次 CVAD 的患者有资格入组。该研究的主要结局是从 CVAD 插入到研究结束时首次发生 CLABSI 的发生率，最长随访时间为 90 天。将进行意向治疗和方案治疗分析。在纳入 50%的患者后将进行中期分析。中期分析的结果和试验的总体进展将由数据安全监测委员会讨论。
荷兰乌得勒支 NedMec 医学伦理委员会已批准该研究（编号 20/370）。所有患者和/或其父母/监护人均签署了参与该试验和发表试验数据的书面知情同意书。该试验的结果将在同行评议的期刊上发表，并在主要结果报告发表后，按合理要求提供数据。
NTR6688；NCT05740150。
