Actively Recruiting
Prospective Observational Cohort Study on Outcomes of Percutaneous Peritoneal Dialysis Catheters
Led by Universitair Ziekenhuis Brussel · Updated on 2023-10-04
500
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
Universitair Ziekenhuis Brussel
Lead Sponsor
U
UMC Utrecht
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with end-stage kidney disease who need peritoneal dialysis (PD) catheter insertion. The goal is to learn more about the outcomes of PD catheters inserted using a percutaneous method, which can be done at the bedside with local anesthesia, unlike the usual laparoscopic surgery that requires general anesthesia. This approach may help patients who cannot undergo general anesthesia or need urgent dialysis. The study is observational and aims to collect data from multiple centers to improve knowledge and skills in this technique. The study focuses on patients aged over 18 who receive percutaneous PD catheter insertion between March 2023 and March 2026 at participating centers. The decision to use the percutaneous method rather than surgery is made by the treating doctor. Data is collected from patients starting four weeks before and up to twelve weeks after the catheter insertion. The study does not involve experimental treatments but tracks outcomes such as catheter function, complications, and dialysis use. Participants will provide demographic and clinical information, and complete quality of life questionnaires (SF-12 and EQ5D-5L) at the start and one year after catheter insertion. Researchers will monitor complications, catheter function, and dialysis usage over time, with follow-up lasting up to three years. The study also evaluates how well centers implement the percutaneous technique and gathers healthcare professionals' feedback. Costs related to the procedure will be recorded immediately after insertion.
CONDITIONS
Brief Title
Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Percutaneous PD catheter insertion between March 1, 2023 and March 1, 2026
- Inclusion possible from 4 weeks before to 12 weeks after catheter insertion
You will not qualify if you...
- Inability to provide informed consent
- Life expectancy less than 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 16 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits depending on timing before or after catheter insertion
Duration - Day of catheter insertion
Participants undergo percutaneous peritoneal dialysis catheter insertion as decided by their treating physician.
1 visit (in-person) for catheter insertion procedure
Duration - Up to 12 months after catheter insertion
Participants are observed for catheter function and potential complications after insertion.
Follow-up visits as part of routine care; frequency varies by center
Duration - Up to 3 years after catheter insertion
Participants are monitored for catheter function, dialysis utilization, and quality of life over the study period.
Annual questionnaire assessments and clinical data collection
Trial Site Locations
Total: 2 locations
1
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Actively Recruiting
2
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
K
Karlien François, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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