Author:
Abdel-fattah Mohamed,Johnson Diana,Constable Lynda,Thomas Ruth,Cotton Seonaidh,Tripathee Sheela,Cooper David,Boran Sue,Dimitropoulos Konstantinos,Evans Suzanne,Granitsiotis Paraskeve,Hashim Hashim,Kilonzo Mary,Larcombe James,Little Paul,MacLennan Sara,Murchie Peter,Myint Phyo Kyaw,N’Dow James,Norrie John,Omar Muhammad Imran,Paterson Catherine,Scotland Graham,Thiruchelvam Nikesh,MacLennan Graeme
Abstract
Abstract
Background
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.
Methods
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.
Discussion
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).
Trial registration
ISRCTN ISRCTN17116445. Registered prospectively on 06 November 2019
Funder
Health Technology Assessment Programme
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference22 articles.
1. Wilde MH, McMahon JM, Crean HF, Brasch J. Exploring relationships of catheter-associated urinary tract infection and blockage in people with long-term indwelling urinary catheters. J Clin Nurs. 2017;26(17-18):2558–71.
2. Shepherd AJ, Mackay WG, Hagen S. Washout policies in long-term indwelling urinary catheterisation in adults. Cochrane Database Syst Rev. 2017;3(3):CD004012.
3. National Institute for Health and Clinical Excellence (NICE). Healthcare-associated infections: prevention and control in primary and community care. 2017; Available at: www.nice.org.uk/guidance/cg139. Accessed 31 Mar 2021.
4. National Health Service. Urinary catheters. 2020; Available at: https://www.nhs.uk/conditions/urinary-catheters/. Accessed 11 Apr 2022.
5. Wilde MH, Mcdonald MV, Brasch J, Mcmahon JM, Fairbanks E, Shah S, et al. Long-term urinary catheter users self-care practices and problems. J Clin Nurs. 2013;22(3-4):356–67.
Cited by
2 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献