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临床试验/NCT07847125
NCT07847125尚未招募不适用

Ultrasound-Guided Percutaneous Peritoneal Dialysis Catheter Insertion for Urgent-Start Dialysis: Feasibility, Technical Success, Safety, and Clinical Outcomes at Assiut University Hospital

Assiut University0 个研究点目标入组 50 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Technical Success of Catheter Placement

研究概览

简要总结

This prospective observational study evaluates the feasibility, technical success, safety, and clinical outcomes of ultrasound-guided percutaneous peritoneal dialysis (PD) catheter insertion for urgent-start dialysis in pediatric patients with acute kidney injury (AKI).

Acute kidney injury in children frequently requires prompt renal replacement therapy. While traditional surgical placement of peritoneal dialysis catheters often requires general anesthesia and an extended waiting period before use, percutaneous insertion under real-time ultrasound guidance using a modified Seldinger technique allows for bedside placement under local anesthesia and rapid initiation of dialysis.

The study includes 50 pediatric patients (ranging from neonates up to 18 years of age) admitted to Assiut University Hospitals who require urgent renal replacement therapy and are candidates for peritoneal dialysis. Participants undergo percutaneous catheter placement guided in real time by ultrasound, followed by the initiation of an urgent-start dialysis protocol. The primary focus is to determine the technical success of the insertion procedure, evaluate catheter function and short-term catheter survival, and record procedure-related complications such as bleeding, dialysate leakage, infection, and mechanical malfunction. Secondary objectives include assessing renal recovery, patient survival to hospital discharge, and the need for conversion to alternative dialysis modalities.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • Pediatric patients (neonates up to 18 years of age) diagnosed with acute kidney injury according to KDIGO or pRIFLE criteria.
  • Clinical indication for urgent renal replacement therapy with candidacy for peritoneal dialysis (due to hemodynamic instability, lack of vascular access, or physician preference).
  • Written informed consent provided by a parent or legal guardian.

排除标准

  • Recent major abdominal surgery, abdominal wall defects, or necrotizing enterocolitis.
  • Diaphragmatic hernia or ventriculoperitoneal (VP) shunt in situ.
  • Uncontrolled peritonitis or intra-abdominal sepsis of surgical origin.
  • Severe coagulopathy precluding safe percutaneous catheter insertion.
  • Refusal of informed consent or inability to comply with protocol follow-up.

研究组 & 干预措施

Pediatric Urgent-Start Peritoneal Dialysis Cohort

Pediatric patients (neonates up to 18 years) diagnosed with acute kidney injury according to KDIGO/pRIFLE criteria who require urgent renal replacement therapy and are candidates for peritoneal dialysis (due to hemodynamic instability, lack of vascular access, or clinical preference). All participants undergo percutaneous peritoneal dialysis catheter placement under real-time ultrasound guidance using a modified Seldinger technique, followed by the initiation of urgent-start peritoneal dialysis. Outcomes assessed include procedural feasibility, technical success, catheter function, short-term catheter survival, and procedure-related complications.

结局指标

主要结局

Technical Success of Catheter Placement

时间窗: 1 hour post-procedure

Technical success is defined as successful percutaneous placement of the peritoneal dialysis catheter into the peritoneal cavity under real-time ultrasound guidance with immediate functional inflow and outflow, confirmed by free instillation and drainage of fluid without leakage or obstruction.

次要结局

未报告次要终点

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Shehab Ezz Eldin Mohamed Mahmoud

Resident

Assiut University

标识符

NCT 编号
NCT07847125
其他研究编号
US-Guided Urgent PD Catheter

日期

首次提交
(7天前)
首次发布
(昨天)
主要完成日期
(明年)
研究完成日期
(明年)
最近核实
(29天前)
最近更新
(昨天)

监管与共享

是否有结果
否

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