Aberdeen Centre for Women's Health Research, University of Aberdeen, Aberdeen, UK.
Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
Trials. 2022 Aug 4;23(1):630. doi: 10.1186/s13063-022-06577-2.
Various washout policies are widely used in adults living with long-term catheters (LTC). There is currently insufficient evidence on the benefits and potential harms of prophylactic LTC washout policies in the prevention of blockages and other LTC-related adverse events, such as urinary tract infections. CATHETER II tests the hypothesis that weekly prophylactic LTC washouts (normal saline or citric acid) in addition to standard LTC care reduce the incidence of catheter blockage requiring intervention compared to standard LTC care only in adults living with LTC.
CATHETER II is a pragmatic three-arm open multi-centre superiority randomised controlled trial with an internal pilot, economic analysis, and embedded qualitative study. Eligible participants are adults aged ≥ 18 years, who have had a LTC in use for ≥ 28 days, have no plans to discontinue the use of the catheter, are able to undertake the catheter washouts, and complete trial documentation or have a carer able to help them. Participants are identified from general practitioner practices, secondary/tertiary care, community healthcare, care homes, and via public advertising strategies. Participants are randomised 1:1:1 to receive a weekly saline (0.9%) washout in addition to standard LTC care, a weekly citric acid (3.23%) washout in addition to standard LTC care or standard LTC care only. Participants and/or carers will receive training to administer the washouts. Patient-reported outcomes are collected at baseline and for 24 months post-randomisation. The primary clinical outcome is catheter blockage requiring intervention up to 24 months post-randomisation expressed per 1000 catheter days. Secondary outcomes include symptomatic catheter-associated urinary tract infection requiring antibiotics, catheter change, adverse events, NHS/ healthcare use, and impact on quality of life.
This study will guide treatment decision-making and clinical practice guidelines regarding the effectiveness of various prophylactic catheter washout policies in men and women living with LTC. This research has received ethical approval from Wales Research Ethics Committee 6 (19/WA/0015).
ISRCTN ISRCTN17116445 . Registered prospectively on 06 November 2019.
在长期留置导管（LTC）的成年人中，广泛使用各种冲洗策略。目前，关于预防性 LTC 冲洗策略在预防阻塞和其他 LTC 相关不良事件（如尿路感染）方面的益处和潜在危害的证据不足。CATHETER II 试验检验了这样一个假设，即在标准 LTC 护理的基础上，每周进行预防性 LTC 冲洗（生理盐水或柠檬酸）可降低需要干预的导管阻塞发生率，与仅接受标准 LTC 护理的患者相比。
CATHETER II 是一项实用的三臂开放性多中心优效性随机对照试验，具有内部试点、经济分析和嵌入式定性研究。合格的参与者是年龄≥18 岁的成年人，他们已经使用 LTC 超过 28 天，没有停止使用导管的计划，能够进行导管冲洗，并且能够完成试验文件记录，或者有一个可以帮助他们的照顾者。参与者是从全科医生诊所、二级/三级护理、社区保健、护理院以及通过公共广告策略确定的。参与者按照 1:1:1 的比例随机分配，分别接受每周一次生理盐水（0.9%）冲洗，标准 LTC 护理，每周一次柠檬酸（3.23%）冲洗，标准 LTC 护理。参与者和/或照顾者将接受冲洗培训。患者报告的结果在基线和随机分组后 24 个月时收集。主要临床结果是随机分组后 24 个月内需要干预的导管阻塞，以每 1000 个导管日计算。次要结果包括需要抗生素治疗的有症状的导管相关性尿路感染、导管更换、不良事件、NHS/医疗保健使用以及对生活质量的影响。
这项研究将为治疗决策和临床实践指南提供指导，以确定男性和女性中各种预防性导管冲洗策略的有效性。这项研究已获得威尔士研究伦理委员会 6 号（19/WA/0015）的伦理批准。
ISRCTN ISRCTN17116445。于 2019 年 11 月 6 日前瞻性注册。
