Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study

Mohamed Abdel-fattah; Diana Johnson; Lynda Constable; Ruth Thomas; Seonaidh Cotton; Sheela Tripathee; David Cooper; Sue Boran; Konstantinos Dimitropoulos; Suzanne Evans; Paraskeve Granitsiotis; Hashim Hashim; Mary Kilonzo; James Larcombe; Paul Little; Sara MacLennan; Peter Murchie; Phyo  Myint; James N’Dow; John Norrie; Muhammad Imran Omar; Catherine Paterson; Graham Scotland; Nikesh Thiruchelvam; Graeme MacLennan

doi:10.1186/s13063-022-06577-2

Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study

Mohamed Abdel-fattah^* (Corresponding Author), Diana Johnson, Lynda Constable, Ruth Thomas, Seonaidh Cotton, Sheela Tripathee, David Cooper, Sue Boran, Konstantinos Dimitropoulos, Suzanne Evans, Paraskeve Granitsiotis, Hashim Hashim, Mary Kilonzo, James Larcombe, Paul Little, Sara MacLennan, Peter Murchie, Phyo Myint, James N’Dow, John NorrieMuhammad Imran Omar, Catherine Paterson, Graham Scotland, Nikesh Thiruchelvam, Graeme MacLennan

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

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.

Original language	English
Article number	630
Number of pages	12
Journal	Trials
Volume	23
Issue number	1
Early online date	4 Aug 2022
DOIs	https://doi.org/10.1186/s13063-022-06577-2
Publication status	Published - 4 Aug 2022

Bibliographical note

Acknowledgements
We gratefully acknowledge B. Braun Medical AG for donating the supply of washout solutions for use in the CATHETER II study. We are grateful for the secretarial and data coordination support from Dianne Dejean. The research team acknowledges the support from the NHS Research Scotland Primary Care Network (particularly Amanda Cardy for support in patient recruitment). The authors also gratefully acknowledge the support of the Centre for Healthcare Randomised Trials; the Clinical Research Networks; the site teams, participants and their carers; and the Trial Steering and Data Monitoring Committees. We are also grateful to Hanne Bruhn for her help in drafting some of the patient-facing documentation for the study.

Funding
The study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (17/30/02). The views expressed are those of the authors and not necessarily those of the NIHR or Department of Health and Social Care.

Keywords

Catheter blockage
Catheter washout solutions
Catheter maintenance solutions
Indwelling catheter
Long-term catheter
Symptomatic catheter-associated urinary tract infection

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Abdel-fattah, M., Johnson, D., Constable, L., Thomas, R., Cotton, S., Tripathee, S., Cooper, D., Boran, S., Dimitropoulos, K., Evans, S., Granitsiotis, P., Hashim, H., Kilonzo, M., Larcombe, J., Little, P., MacLennan, S., Murchie, P., Myint, P., N’Dow, J., ... MacLennan, G. (2022). Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study. Trials, 23(1), Article 630. https://doi.org/10.1186/s13063-022-06577-2

Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study. / Abdel-fattah, Mohamed (Corresponding Author); Johnson, Diana ; Constable, Lynda et al.
In: Trials, Vol. 23, No. 1, 630, 04.08.2022.

Research output: Contribution to journal › Article › peer-review

Abdel-fattah, M , Johnson, D , Constable, L, Thomas, R, Cotton, S , Tripathee, S , Cooper, D, Boran, S, Dimitropoulos, K, Evans, S, Granitsiotis, P, Hashim, H, Kilonzo, M, Larcombe, J, Little, P, MacLennan, S , Murchie, P , Myint, P, N’Dow, J, Norrie, J, Omar, MI, Paterson, C, Scotland, G, Thiruchelvam, N & MacLennan, G 2022, 'Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study', Trials, vol. 23, no. 1, 630. https://doi.org/10.1186/s13063-022-06577-2

Abdel-fattah M , Johnson D , Constable L, Thomas R, Cotton S , Tripathee S et al. Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study. Trials. 2022 Aug 4;23(1):630. Epub 2022 Aug 4. doi: 10.1186/s13063-022-06577-2

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AU - Constable, Lynda

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AU - Cotton, Seonaidh

AU - Tripathee, Sheela

AU - Cooper, David

AU - Boran, Sue

AU - Dimitropoulos, Konstantinos

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AU - Granitsiotis, Paraskeve

AU - Hashim, Hashim

AU - Kilonzo, Mary

AU - Larcombe, James

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AU - Omar, Muhammad Imran

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