Abdel-Fattah Mohamed, Omar Muhammad Imran, Johnson Diana, Cooper David, Constable Lynda, Tripathee Sheela, MacLennan Sara J, Dimitropoulos Konstantinos, Evans Suzanne, Hashim Hashim, Kilonzo Mary, Larcombe James, Little Paul, Murchie Peter, Myint Phyo Kyaw, N'Dow James, Paterson Catherine, Powell Karen, Scotland Graham, Thiruchelvam Nikesh, Young Amanda, Cotton Seonaidh, Norrie John, MacLennan Graeme
Aberdeen Centre for Women's Health Research, University of Aberdeen, Aberdeen, UK
Academic Urology Unit, University of Aberdeen, Aberdeen, UK.
BMJ Open. 2024 Dec 2;14(12):e087203. doi: 10.1136/bmjopen-2024-087203.
Do weekly prophylactic saline or acidic catheter washouts in addition to standard long-term catheter (LTC) care improve the outcomes of adults with LTC compared with standard LTC care only.
Three-arm superiority open-label randomised controlled trial.
UK community-based study.
80 adults with LTC (any type/route) ≥28 days in situ with no plans to discontinue and able to self-manage the washouts/study documentation with/without a carer.
Randomly allocated (26:27:27) to receive standard LTC care with weekly saline or weekly acidic or no prophylactic washouts for up to 24 months.
The primary outcome was catheter blockage requiring intervention (per 1000 catheter days). Secondary outcomes were symptomatic catheter-associated urinary tract infection (S-CAUTI) requiring antibiotics, adverse events, participants' quality of life and day-to-day activities, acceptability and adherence.
Outcomes reported for 25 saline, 27 acidic and 26 control participants. LTC blockages (per 1000 catheter days) requiring treatment were 9.96, 10.53 and 20.92 in the saline, acidic and control groups, respectively. The incident rate ratio (IRR) favours the washout groups (saline 0.65 (97.5% CI 0.24 to 1.77); p=0.33 and acidic 0.59 (97.5% CI 0.22 to 1.63); p=0.25), although not statistically significant. The S-CAUTI rate (per 1000 catheter days) was 3.71, 6.72 and 8.05 in the saline, acidic and control groups, respectively. The IRR favours the saline group (saline 0.40 (97.5% CI 0.20 to 0.80); p=0.003 and acidic 0.98 (97.5% CI 0.54 to 1.78); p=0.93). The trial closed before reaching target recruitment due to reduced research capacity during the COVID-19 pandemic.
Early closure and small sample size limits our ability to provide a definite answer. However, the observed non-statistically significant differences over control are favourable for lower rates of LTC blockages without a concomitant rise in S-CAUTI. The results support a multinational randomised controlled trial of catheter washouts in patients with LTC to ascertain their clinical and cost-effectiveness.
ISRCTN17116445.
与仅采用标准长期导管（LTC）护理相比，在标准长期导管护理基础上，每周进行预防性生理盐水或酸性导管冲洗，是否能改善长期导管护理成年患者的预后。
三臂优效性开放标签随机对照试验。
基于英国社区的研究。
80例长期导管护理（任何类型/途径）≥28天且无计划停用、能够在有或没有护理人员的情况下自行管理冲洗/研究文件的成年患者。
随机分配（26:27:27）接受标准长期导管护理，每周进行生理盐水冲洗或每周进行酸性冲洗或不进行预防性冲洗，为期最长24个月。
主要结局是需要干预的导管堵塞（每1000导管日）。次要结局是需要使用抗生素治疗的有症状的导管相关尿路感染（S-CAUTI）、不良事件、参与者的生活质量和日常活动、可接受性和依从性。
报告了25例接受生理盐水冲洗、27例接受酸性冲洗和26例对照组参与者的结局。生理盐水组、酸性冲洗组和对照组中需要治疗的长期导管堵塞（每1000导管日）分别为9.96、10.53和20.92。发生率比（IRR）有利于冲洗组（生理盐水组0.65（97.5%CI 0.24至1.77）；p=0.33，酸性冲洗组0.59（97.5%CI 0.22至1.63）；p=0.25），尽管无统计学意义。生理盐水组、酸性冲洗组和对照组中S-CAUTI发生率（每1000导管日）分别为3.71、6.72和8.05。发生率比有利于生理盐水组（生理盐水组0.
