Abstract
Objectives 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.
Design Three-arm superiority open-label randomised controlled trial.
Setting UK community-based study.
Participants 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.
Interventions 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.
Primary and secondary outcome measures 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.
Results 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.
Conclusions 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.
Design Three-arm superiority open-label randomised controlled trial.
Setting UK community-based study.
Participants 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.
Interventions 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.
Primary and secondary outcome measures 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.
Results 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.
Conclusions 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.
| Original language | English |
|---|---|
| Article number | e087203 |
| Number of pages | 14 |
| Journal | BMJ Open |
| Volume | 14 |
| Issue number | 12 |
| Early online date | 2 Dec 2024 |
| DOIs | |
| Publication status | Published - Dec 2024 |
Bibliographical note
AcknowledgmentsWe thank B. Braun Medical AG for donating the supply of washout solutions (Uro-Tainer NaCl 0.9% and Uro-Tainer Twin Suby G) for this study. We are grateful for the secretarial, data co-ordination and data monitoring support from Dianne Dejean, Rebecca Bruce and Gillian Ferry. We acknowledge the support from Amanda Cardy on behalf of the NHS Research Scotland Primary Care Network. We also gratefully acknowledge the support of the Centre for Healthcare Randomised Trials; the Clinical Research Networks; the participants and their carers; the Trial Steering and Data Monitoring Committees and the teams at sites (Angela Allan, Sirjana Devkota, Judith Falconer, Fiona Flett, Danielle Pirie, Pauline Ganley, Gayle Hutcheon, Lynne Walker, Debra Barnett, Lucy Shipp, Jemma Tuffney, Cerian Williams, Dr Stacey Fisher, Katie Boichat, Dr James Kennard, Kate Hannaby, Dr Robin Fox, Libby Thomas, Dr Vibhore Prasad, Rachael Ludlow, Sarah Shelton, Mr Nikesh Thiruchelvam, Dr Suzanne Biers, Kelly Leonard, Dr Grace Ding, Lydia Owen, Dr Tony Avery, Lucy Morton, Kirsty Williams, Dr Matthew Gaw, Donna Jacob, Gareth Kennard-Holden, Lisa Roche, Alison Doherty, Lisa Mellish, Meryl Rees, Lisa Roche, Naveen Uddin, Dr Lois Mugleston, Sarah Richardson, Helen Greaves, Charlotte Adams-Heath, Eve Etell-Kirby, Josie Newton, Joanna Wright, Dr Matthew Wallard, Dr William Briggs, Lisa Westwood, Dr Rina Miah, Beverley Buck, Jill Ducker, Nicky Todd, Jacqui Vicars, Dr Zelda Cheng, Sue Harrison, Varsha Margrette, Professor Kamlesh Khunti, John Cvancara, Kate Ellis, Karen Nelson, Sara-Jane Barlow, Emma Temlett, Nicholas Faure Walker, Oluwaseun Adeyemi, David Benerayan, Pearl Dulawan, Philip Francisco, Ida Peralta, Amelia Te, Dr Gareth Forbes, Thomas Brophy, Joyce Banda, Hannah Butler, Houda Chea, Benedykt Cien, Ananya Saha, Sebastian Shereen, Dr Richard Reed, Tracey Leaper, Tracey Worland, Carrie Felgate, Paula Coventry, Lisa Dyche, Lucy Hamilton, Geraint Hughes, Jill Dimopoulos, Louise Jones, Christina Tanney, Lyndsey Wilkinson, Dr Sam Glanville, Natasha Campbell, Dr Jonathan Wild, Dr Nasir Hannan, Sarah Mead, Rebecca Roberts, Nicole Weir, Shalom Srirangam, Carl Andrews, Laura Bennett, Rachel Harding, Jeanette Hargreaves, Farzana Masters, Dr Areej Paracha, Dr Adrian Beltran-Martinez, Katie Dale, Dr Samuel Lassa, Rebecca Price, Julie Shaw, Dr Magdy Al-Gohary, Katie Cook, Karen O'Rourke, Dr Nick Wooding, Clare Murray, Dr Susan Waldron, Dr Kyle Knox, Katherine Blaze, Sam Towers, Dr Claire Hombersley, Sara Ward, Dr David Lewis, Carol Burgess, Carrie Gelhardt, Ann Kent, Dr Jonathan Marsden, Johanna Brown, Claire Sampson, Dr Jack Bond, Samantha McErlane, Dr Adam Lewandowski, Dr Hannah Ferrington, Dr Victoria Glover, Jill Larkin, Debbie Warwick). We are also grateful to Ruth Thomas for drafting the documentation for the study and to Hanne Bruhn for her help in this.
Data Availability Statement
Data are available on reasonable request. A request to access the datasets generated during the trial should be directed in the first instance to the corresponding author (Professor Mohamed Abdel-fattah, [email protected]). The datasets collected in questionnaires at all timepoints and the baseline, monthly and serious adverse event case report forms for all 80 participants recruited to the trial are available. The dataset is available in fully anonymised electronic form, at an individual level and in accordance with participant consent. The data dictionaries, study protocol, statistical analysis plan, patient information leaflets and template case report forms are also available on request to facilitate interpretation of data. Questionnaire templates, or parts thereof, may be available pending review of the relevant licensing agreements. Data for the study are currently available within a local repository at the University of Aberdeen and will be retained for a period of at least 10 years after close of trial in accordance with funder, sponsor and local archiving procedures. Applicants will require to complete a data request form that will be reviewed by a Data Sharing Committee, which includes the Chief Investigator. Applications will be considered on a case-by-case basis from bonafide researchers. We are obligated to ensure that optimal use is made of the data that are collected for research and we recognise the value of sharing individual-level data. The interests of research participants, researchers and other stakeholders will be considered when considering each application. A fully authorised data sharing agreement will be required prior to the release of data.Prepublication history and additional supplemental material for this paper are available online.
Funding
This study was funded by the National Institute for Health Research Health Technology Assessment Programme (17/30/02). The supply of washout solutions for use in the CATHETER II study were donated by B. Braun Medical AG. The study was co sponsored by University of Aberdeen and Grampian Health Board.
| Funders | Funder number |
|---|---|
| National Institute for Health and Care Research | 17/30/02 |
Fingerprint
Dive into the research topics of 'CATHETER II: a 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'. Together they form a unique fingerprint.Cite this
- APA
- Standard
- Harvard
- Vancouver
- Author
- BIBTEX
- RIS