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CATHETER II: a randomised controlled trial comparing the clinical effectiveness of various washout policies versus no washout policy in preventing catheter-associated complications in adults living with long-term catheters

Authors :
John Norrie
Graeme Maclennan
David Cooper
Paul Little
Peter Murchie
Phyo Kyaw Myint
Mohamed Abdel-fattah
Mary Kilonzo
Muhammad Imran Omar
Diana Johnson
Sara J Maclennan
James N'Dow
Graham Scotland
Amanda Young
Seonaidh Cotton
James Larcombe
Nikesh Thiruchelvam
Catherine Paterson
Lynda Constable
Hashim Hashim
Sheela Tripathee
Konstantinos Dimitropoulos
Suzanne Evans
Karen Powell
Source :
BMJ Open, Vol 14, Iss 12 (2024)
Publication Year :
2024
Publisher :
BMJ Publishing Group, 2024.

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.Trial registration number ISRCTN17116445.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20240872 and 20446055
Volume :
14
Issue :
12
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.793dc7a9d36144c49b690cc7190db05b
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2024-087203