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
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...
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| Format: | Article |
| Language: | English |
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BMC
2022-08-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06577-2 |
| _version_ | 1818504903639695360 |
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| author | 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 Kyaw Myint James N’Dow John Norrie Muhammad Imran Omar Catherine Paterson Graham Scotland Nikesh Thiruchelvam Graeme MacLennan |
| author_facet | 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 Kyaw Myint James N’Dow John Norrie Muhammad Imran Omar Catherine Paterson Graham Scotland Nikesh Thiruchelvam Graeme MacLennan |
| author_sort | Mohamed Abdel-fattah |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-10T21:43:31Z |
| format | Article |
| id | doaj.art-3571f303880a4c9c9c8ce3edad02fbec |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-10T21:43:31Z |
| publishDate | 2022-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-3571f303880a4c9c9c8ce3edad02fbec2022-12-22T01:32:25ZengBMCTrials1745-62152022-08-0123111210.1186/s13063-022-06577-2Randomised 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 studyMohamed Abdel-fattah0Diana Johnson1Lynda Constable2Ruth Thomas3Seonaidh Cotton4Sheela Tripathee5David Cooper6Sue Boran7Konstantinos Dimitropoulos8Suzanne Evans9Paraskeve Granitsiotis10Hashim Hashim11Mary Kilonzo12James Larcombe13Paul Little14Sara MacLennan15Peter Murchie16Phyo Kyaw Myint17James N’Dow18John Norrie19Muhammad Imran Omar20Catherine Paterson21Graham Scotland22Nikesh Thiruchelvam23Graeme MacLennan24Aberdeen Centre for Women’s Health Research, University of AberdeenCentre for Healthcare Randomised Trials, University of AberdeenCentre for Healthcare Randomised Trials, University of AberdeenCentre for Healthcare Randomised Trials, University of AberdeenCentre for Healthcare Randomised Trials, University of AberdeenAcademic Urology Unit, University of AberdeenHealth Services Research Unit, University of AberdeenThe Queen’s Nursing InstituteAcademic Urology Unit, University of AberdeenBladder Health UKLothian Health BoardNorth Bristol NHS TrustHealth Economics Research Unit, Institute of Applied Health Sciences, University of AberdeenJMed LimitedPrimary Care Research Centre, University of SouthamptonAcademic Urology Unit, University of AberdeenAcademic Primary Care Research Group, University of AberdeenAgeing Clinical & Experimental Research Team, University of AberdeenAcademic Urology Unit, University of AberdeenUsher Institute, University of EdinburghAcademic Urology Unit, University of AberdeenSchool of Nursing, Midwifery and Public Health, University of CanberraHealth Economics Research Unit, Institute of Applied Health Sciences, University of AberdeenCambridge University Hospitals NHS Foundation TrustCentre for Healthcare Randomised Trials, University of AberdeenAbstract 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 2019https://doi.org/10.1186/s13063-022-06577-2Catheter blockageCatheter washout solutionsCatheter maintenance solutionsIndwelling catheterLong-term catheterSymptomatic catheter-associated urinary tract infection |
| spellingShingle | 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 Kyaw Myint James N’Dow John Norrie Muhammad Imran Omar Catherine Paterson Graham Scotland Nikesh Thiruchelvam Graeme MacLennan 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 Catheter blockage Catheter washout solutions Catheter maintenance solutions Indwelling catheter Long-term catheter Symptomatic catheter-associated urinary tract infection |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Catheter blockage Catheter washout solutions Catheter maintenance solutions Indwelling catheter Long-term catheter Symptomatic catheter-associated urinary tract infection |
| url | https://doi.org/10.1186/s13063-022-06577-2 |
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