Evaluation of antibiotic-treated catheters to prevent peritonitis associated with peritoneal dialysis

Not Applicable

• Conditions: Adults who opt for peritoneal dialysis and therefore require the insertion of a peritoneal dialysis catheter; Urological and Genital Diseases

• Registration Number: ISRCTN26347295
• Lead Sponsor: niversity Hospitals of Derby and Burton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-20
• Last Update Posted: 15 July 2024
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Aged 18 years or older
2. End-stage kidney disease of any cause
3. Elective PD catheter insertion

Exclusion Criteria

1. Documented allergy to rifampicin, sparfloxaxacin (or any fluoroquinolone), triclosan, or silicone
2. Pregnant, likely to become pregnant, or breastfeeding
3. Emergency PD catheter insertion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of an antimicrobial-impregnated catheter, measured using the rate of adverse events to the antimicrobials or the impregnation process encountered by PD patients during 6 months of observation

Secondary Outcome Measures

Name	Time	Method
1. Patient acceptability determined by modified Integrated Palliative Care Outcome Scale (IPOS) Renal questionnaire and patient acceptability questionnaire at baseline, 3 weeks, 3 months and 6 months.<br>2. Peritoneal dialysis-related infections: PD peritonitis, exit site/tunnel infection identified and defined using local protocols and International Society for Peritoneal Dialysis Guidelines; microorganism antibiotic resistance profile of organisms causing catheter-related infections colonisation of PD catheters removed within the study period, measured using clinical assessment and laboratory culture techniques during 6 months of observation. <br>3. Technique failure: transfer from peritoneal dialysis to hemodialysis measured using clinical records and observation during 6 months of observation.