Chronic Kidney Disease (CKD) Stage 5NCT07465445
PD Catheter Survival: Modified Percutaneous vs Moncrief-Popovich
A study testing Embedded Peritoneal catheter placement and Modified Percutaneous PD catheter placement in people with Chronic Kidney Disease (CKD) Stage 5 and Peritoneal Dialysis Access, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (CKD) Stage 5, Peritoneal Dialysis Access
- What is being tested?
- Embedded Peritoneal catheter placement and Modified Percutaneous PD catheter placement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Jalisco, 44280
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Embedded Peritoneal catheter placement, Modified Percutaneous PD catheter placement
- Keywords
- Chronic kidney disease, Peritoneal Dialysis, Moncrief, Peritoneal catheter placement
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embedded Peritoneal catheter placementProcedure or surgery
Peritoneal dialysis catheter placement using Moncrief-Popovich Technique performed by nephrologist
Modified Percutaneous PD catheter placementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CONVENTIONAL MODIFIED PERCUTANEOUS PLACEMENT | Active comparator | 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. Receives: Procedure: Modified Percutaneous PD catheter placement |
| MONCRIEF-POPOVICH TECHNIQUE | Experimental | 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. Receives: Procedure: Embedded Peritoneal catheter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD catheter survival and functionality
Functionality assessed by ability to perform adequate PD exchanges and absence of mechanical obstruction to the end of follow-up
Measured: 12 months
Secondary outcomes (5)
Peritonitis incidence
Number and rate of PD-related peritonitis episodes during follow-up
Measured: 12 months
Early infectious complications
Incidence of exit-site infection or tunnel infection within 30 days after insertion
Measured: 30 days
Change of dialysis modality due to catheter failure
Proportion of patients requiring modality change to hemodialysis secondary to catheter-related issues
Measured: 12 months
Late infectious complications
Incidence of exit-site infection, tunnel infection beyond 30 days
Measured: 12 months
Adverse events related to placement procedure
Incidence of catheter migration, obstruction, leak, malfunction, bleeding, visceral injury, requiring intervention
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD) Stage 5Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramon Medina-Gonzalez, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465445
- Sponsor's protocol ID
- CEI 128/24
- Status last verified
- Feb 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07465445
- Acronym / sponsor ID
- CEI 128/24
- Keywords
- Chronic kidney disease, Peritoneal Dialysis, Moncrief, Peritoneal catheter placement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONVENTIONAL MODIFIED PERCUTANEOUS PLACEMENT | Active comparator | Procedure: Modified Percutaneous PD catheter placementConventional 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. |
| MONCRIEF-POPOVICH TECHNIQUE | Experimental | Procedure: Embedded Peritoneal catheter placementPeritoneal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
- Withdrawal of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embedded Peritoneal catheter placementPeritoneal dialysis catheter placement using Moncrief-Popovich Technique performed by nephrologist | Procedure or surgery | MONCRIEF-POPOVICH TECHNIQUE |
| Modified Percutaneous PD catheter placementPeritoneal 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. | Procedure or surgery | CONVENTIONAL MODIFIED PERCUTANEOUS PLACEMENT |
Primary outcome
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
5 secondary outcomes
Peritonitis incidence
Time frame: 12 months
Early infectious complications
Time frame: 30 days
Change of dialysis modality due to catheter failure
Time frame: 12 months
Late infectious complications
Time frame: 12 months
Adverse events related to placement procedure
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embedded Peritoneal catheter placement and Modified Percutaneous PD catheter placement in people with Chronic Kidney Disease (CKD) Stage 5 and Peritoneal Dialysis Access, run by Hospital Civil de Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD catheter survival and functionality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.