Catheter Survival and Functionality of Peritoneal Dialysis Catheters Placed by Conventional Modified Percutaneous Technique Versus Moncrief-Popovich Technique in Adults With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PD catheter survival and functionality
研究概览
简要总结
Peritoneal dialysis (PD) catheter placement technique may affect catheter survival, functionality and infection risk. The Moncrief-Popovich (subcutaneous burying or embedding) technique was developed to reduce exit-site/tunnel infections during the interval between insertion and first use.
Objective: Compare PD catheter survival, functionality and complication rates between conventional modified percutaneous placement and Moncrief-Popovich in adults initiating planned PD.
Brief methods: Prospective, randomized, parallel-arm study enrolling adult CKD patients scheduled for planned PD initiation and catheter placement at Hospital Civil de Guadalajara between Jan 2024 and Dec 2025. Patients randomized 1:1 to conventional modified percutaneous placement group or Moncrief-Popovich buried catheter group. Primary outcome is catheter survival/functionality during follow-up. Secondary outcomes include infectious and mechanical complications, peritonitis incidence, and need to change dialysis modality.
详细描述
This prospective, randomized, comparative longitudinal study evaluates PD catheter survival and functionality in adult patients with advanced chronic kidney disease undergoing planned PD catheter placement at Hospital Civil de Guadalajara "Fray Antonio Alcalde" from January 2024 to December 2025. Eligible patients are randomized 1:1 to receive either the conventional modified percutaneous catheter placement (Group A) or the Moncrief-Popovich technique with subcutaneous burial of the distal catheter segment until exteriorization (Group B). Data are collected from medical records and nephrology clinic follow-up visits. Outcomes include catheter survival time, functional status at baseline and during follow-up, early and late infectious (exit-site infection, tunnel infection, peritonitis) and mechanical complications, and requirement for dialysis modality change due to catheter failure. Statistical analyses compare rates and time-to-event outcomes between groups; significance set at p < 0.05. Study procedures comply with institutional ethics oversight and informed consent requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic kidney disease requiring initiation of renal replacement therapy with planned peritoneal dialysis.
- •Candidate for PD catheter placement by percutaneous techniques (either conventional modified percutaneous or Moncrief-Popovich).
- •Provide informed consent and available for clinical follow-up.
排除标准
- •Recent major abdominal surgery
- •Active abdominal infections at the time of catheter placement
- •Anatomical contraindications to peritoneal dialysis
- •Requiring urgent start of PD (uremic syndrome, sever hyperkalemia, severe metabolic acidosis, negligible residual renal function, severe hypervolemia or acute pulmonary edema)
- •Elimination Criteria:
- •Withdrawal of informed consent
- •Loss to follow-up
- •Non-catheter-related events necessitating suspension of PD that preclude further study participation
研究组 & 干预措施
CONVENTIONAL MODIFIED PERCUTANEOUS PLACEMENT
Conventional Modified Percutaneous Placement: Description: Peritoneal dialysis catheter placed at bedside using the center's conventional modified percutaneous technique (nephrologist-performed), catheter externalized and tunneled per standard protocol; catheter used following standard healing period and center procedures.
干预措施: Modified Percutaneous PD catheter placement (Procedure)
MONCRIEF-POPOVICH TECHNIQUE
Peritoneal dialysis catheter placed with subcutaneous burial or embedding of the external catheter segment (Moncrief-Popovich technique). Catheter remains embedded until planned exteriorization and initiation of dialysis per protocol; exteriorization performed for PD initiation.
干预措施: Embedded Peritoneal catheter placement (Procedure)
结局指标
主要结局
PD catheter survival and functionality
时间窗: 12 months
Functionality assessed by ability to perform adequate PD exchanges and absence of mechanical obstruction to the end of follow-up
次要结局
- Peritonitis incidence(12 months)
- Early infectious complications(30 days)
- Change of dialysis modality due to catheter failure(12 months)
- Late infectious complications(12 months)
- Adverse events related to placement procedure(2 weeks)
研究者
Ramon Medina-Gonzalez
Associate Physician
Hospital Civil de Guadalajara