- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465445
PD Catheter Survival: Modified Percutaneous vs Moncrief-Popovich
Catheter Survival and Functionality of Peritoneal Dialysis Catheters Placed by Conventional Modified Percutaneous Technique Versus Moncrief-Popovich Technique in Adults With Chronic Kidney Disease
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jalisco
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Guadalajara, Jalisco, Mexico, 44280
- Hospital Civil de Guadalajara "Fray Antonio Alcalde"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
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.
|
|
Experimental: 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.
|
Peritoneal dialysis catheter placement using Moncrief-Popovich Technique performed by nephrologist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peritonitis incidence
Time Frame: 12 months
|
Number and rate of PD-related peritonitis episodes during follow-up
|
12 months
|
|
Early infectious complications
Time Frame: 30 days
|
Incidence of exit-site infection or tunnel infection within 30 days after insertion
|
30 days
|
|
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
|
12 months
|
|
Late infectious complications
Time Frame: 12 months
|
Incidence of exit-site infection, tunnel infection beyond 30 days
|
12 months
|
|
Adverse events related to placement procedure
Time Frame: 2 weeks
|
Incidence of catheter migration, obstruction, leak, malfunction, bleeding, visceral injury, requiring intervention
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency, Chronic
Other Study ID Numbers
- CEI 128/24
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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