NIPH Clinical Trials Search

ASCA-PD study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	End-stage renal failure
Date of first enrollment	16/05/2025
Target sample size	250
Countries of recruitment
Study type	Interventional
Intervention(s)	Randomization of catheters inserted into the peritoneal cavity at the time of induction of peritoneal dialysis, silver CAPD catheters or conventional catheters

Outcome(s)

Primary Outcome

All exit-site and tunnel infections (composite endpoint) occurring within 12 months after exit-site formation (peritoneal dialysis initiation)

Secondary Outcome

1) 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. 2) The first occurrence of exit-site and tunnel infections within 12 months after exit-site creation (peritoneal dialysis initiation). 3) 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. 4) Exit-site and tunnel infections occurring within 30 days after exit-site creation (peritoneal dialysis initiation). 5) All cases of peritonitis occurring after catheter insertion. 6) Catheter removal after catheter insertion (regardless of the reason for removal). 7) 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. 8) Catheter patency. 9) Allergic reactions such as contact dermatitis, eosinophilia, and eosinophilic peritonitis after catheter insertion. 10) Refractory or recurrent exit-site infections, tunnel infections, and peritonitis. 11) 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). 12) Technique failure (transition to hemodialysis for more than 30 days, or death) *Note: Kidney transplantation is censored. 13) Transition from peritoneal dialysis to hybrid therapy (combination of hemodialysis and peritoneal dialysis).

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	New planned peritoneal dialysis initiation patients Age restriction: 18 years and older
Exclude criteria	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)