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Active, Not Recruiting

NCT Number: NCT07465445

PD Catheter Survival: Modified Percutaneous vs Moncrief-Popovich

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Kidney Disease (CKD) Stage 5 Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Dialysis Access Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44280, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Embedded Peritoneal catheter placement

Procedure

Peritoneal dialysis catheter placement using Moncrief-Popovich Technique performed by nephrologist

Modified Percutaneous PD catheter placement

Procedure

Peritoneal dialysis catheter placed at bedside using conventional modified percutaneous technique, catheter tunneled and externalized per standard protocol; catheter used following standard healing period and center procedures performed by nephrologist.

Primary outcomes

  1. PD catheter survival and functionality

    Time frame: 12 months

    Functionality assessed by ability to perform adequate PD exchanges and absence of mechanical obstruction to the end of follow-up

Secondary outcomes

  1. Peritonitis incidence

    Time frame: 12 months

    Number and rate of PD-related peritonitis episodes during follow-up

  2. Early infectious complications

    Time frame: 30 days

    Incidence of exit-site infection or tunnel infection within 30 days after insertion

  3. Change of dialysis modality due to catheter failure

    Time frame: 12 months

    Proportion of patients requiring modality change to hemodialysis secondary to catheter-related issues

  4. Late infectious complications

    Time frame: 12 months

    Incidence of exit-site infection, tunnel infection beyond 30 days

  5. Adverse events related to placement procedure

    Time frame: 2 weeks

    Incidence of catheter migration, obstruction, leak, malfunction, bleeding, visceral injury, requiring intervention

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study title

Catheter Survival and Functionality of Peritoneal Dialysis Catheters Placed by Conventional Modified Percutaneous Technique Versus Moncrief-Popovich Technique in Adults With Chronic Kidney Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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