ASCA-PD study (ASCA-PD study)
- Conditions
- End-stage renal failure
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 250
New planned peritoneal dialysis initiation patients Age restriction: 18 years and older
1)Patients requiring reintroduction after kidney transplantation or hemodialysis 2)Emergency peritoneal dialysis initiation patients 3)Cases involving the creation of an exit site in special locations with extended catheters (excluding upper abdominal exit sites) 4)Patients with a history of metal allergies, including sensitivity to silver. 5)Patients with a prognosis of less than one year at the time of initiation (e.g., terminal cancer patients) 6)Patients with a history of Severe liver cirrhosis (Child-Pugh grade C) 7)Complications with skin conditions such as common infections or atopic dermatitis 8)Patients with gastrostomy or colostomy 9)Use of immunosuppressants (including oral and/or intravenous corticosteroids administration)
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method All exit-site and tunnel infections (composite endpoint) 12 months after exit-site formation (peritoneal dialysis initiation) All exit-site and tunnel infections (composite endpoint)
- Secondary Outcome Measures
Name Time Method First occurrence of exit-site and tunnel infections with competing risks 12 months after exit-site creation The first occurrence of exit-site and tunnel infections within 12 months after exit-site creation (peritoneal dialysis initiation), with catheter removal not due to infection and death considered as competing risk factors.
Exit-site and tunnel infections within 30 days 30 days after exit-site creation Exit-site and tunnel infections occurring within 30 days after exit-site creation (peritoneal dialysis initiation).
All cases of peritonitis after catheter insertion All cases of peritonitis occurring after catheter insertion.
Refractory or recurrent infections Refractory or recurrent exit-site infections, tunnel infections, and peritonitis.
Colony formation and culture results 12 months after exit-site creation or at catheter removal within 12 months Presence of colony formation at the exit site and culture results at the end of observation (12 months after exit-site creation or at the time of catheter removal within 12 months).
Technique failure Technique failure (transition to hemodialysis for more than 30 days, or death) *Note: Kidney transplantation is censored.
All exit-site and tunnel infections within 12 months 12 months after exit-site creation All exit-site and tunnel infections occurring within 12 months after exit-site creation (peritoneal dialysis initiation), with catheter removal not due to infection considered and death.
First occurrence of exit-site and tunnel infections within 12 months 12 months after exit-site creation The first occurrence of exit-site and tunnel infections within 12 months after exit-site creation (peritoneal dialysis initiation).
Catheter removal after insertion Catheter removal after catheter insertion (regardless of the reason for removal).
Catheter removal due to infection or complications 30 days after catheter insertion Catheter removal due to infection, exit-site or tunnel infections requiring surgical intervention, subcutaneous cuff extrusion, and death within 30 days due to peritonitis after catheter insertion.
Catheter patency Catheter patency.
Allergic reactions after catheter insertion Allergic reactions such as contact dermatitis, eosinophilia, and eosinophilic peritonitis after catheter insertion.
Transition to hybrid therapy Transition from peritoneal dialysis to hybrid therapy (combination of hemodialysis and peritoneal dialysis).