跳至主要内容
临床试验/jRCTs052250003
jRCTs052250003招募中不适用

The antibiotic effect of silver CAPD catheter on peritoneal dialysis-related infections : a multicenter randomized open-label trial (ASCA-PD study)

未提供0 个研究点目标入组 250 人开始时间: 2025年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
250
主要终点
All exit-site and tunnel infections (composite endpoint)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 No limit(—)
性别
All

入选标准

  • New planned peritoneal dialysis initiation patients
  • Age restriction: 18 years and older

排除标准

  • Patients requiring reintroduction after kidney transplantation or hemodialysis
  • Emergency peritoneal dialysis initiation patients
  • Cases involving the creation of an exit site in special locations with extended catheters (excluding upper abdominal exit sites)
  • Patients with a history of metal allergies, including sensitivity to silver.
  • Patients with a prognosis of less than one year at the time of initiation (e.g., terminal cancer patients)
  • Patients with a history of Severe liver cirrhosis (Child-Pugh grade C)
  • Complications with skin conditions such as common infections or atopic dermatitis
  • Patients with gastrostomy or colostomy
  • Use of immunosuppressants (including oral and/or intravenous corticosteroids administration)

结局指标

主要结局

All exit-site and tunnel infections (composite endpoint)

时间窗: 12 months after exit-site formation (peritoneal dialysis initiation)

All exit-site and tunnel infections (composite endpoint)

次要结局

  • All exit-site and tunnel infections within 12 months(12 months after exit-site creation)
  • First occurrence of exit-site and tunnel infections within 12 months(12 months after exit-site creation)
  • First occurrence of exit-site and tunnel infections with competing risks(12 months after exit-site creation)
  • Exit-site and tunnel infections within 30 days(30 days after exit-site creation)
  • All cases of peritonitis after catheter insertion
  • Catheter removal after insertion
  • Catheter removal due to infection or complications(30 days after catheter insertion)
  • Catheter patency
  • Allergic reactions after catheter insertion
  • Refractory or recurrent infections
  • Colony formation and culture results(12 months after exit-site creation or at catheter removal within 12 months)
  • Technique failure
  • Transition to hybrid therapy

研究者

发起方
未提供

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