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
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