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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

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
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
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).
1745-6215
Abdel-fattah, Mohamed
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Johnson, Diana
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Constable, Lynda
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Thomas, Ruth
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Cotton, Seonaidh
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Tripathee, Sheela
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Cooper, David
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Boran, Sue
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Dimitropoulos, Konstantinos
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Evans, Suzanne
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Granitsiotis, Paraskeve
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Hashim, Hashim
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Kilonzo, Mary
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Larcombe, James
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Little, Paul
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Maclennan, Sara
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Murchie, Peter
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Myint, Phyo Kyaw
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N’dow, James
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Norrie, John
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Paterson, Catherine
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Scotland, Graham
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Thiruchelvam, Nikesh
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Maclennan, Graeme
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Abdel-fattah, Mohamed
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Johnson, Diana
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Constable, Lynda
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Thomas, Ruth
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Cotton, Seonaidh
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Tripathee, Sheela
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Cooper, David
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Boran, Sue
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Dimitropoulos, Konstantinos
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Evans, Suzanne
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Granitsiotis, Paraskeve
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Hashim, Hashim
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Kilonzo, Mary
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Larcombe, James
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Little, Paul
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Maclennan, Sara
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Murchie, Peter
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Myint, Phyo Kyaw
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N’dow, James
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Norrie, John
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Omar, Muhammad Imran
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Paterson, Catherine
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Scotland, Graham
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Thiruchelvam, Nikesh
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Maclennan, Graeme
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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 and Maclennan, Graeme (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). (doi:10.1186/s13063-022-06577-2).

Record type: Article

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).

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Accepted/In Press date: 20 July 2022
Published date: 4 August 2022

Identifiers

Local EPrints ID: 476872
URI: http://eprints.soton.ac.uk/id/eprint/476872
ISSN: 1745-6215
PURE UUID: c9ab9078-95b3-467b-b22b-9da8efb61db4
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873

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Date deposited: 18 May 2023 16:47
Last modified: 12 Jul 2024 01:35

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Contributors

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

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