Prospective Observational Cohort Study on the Outcomes of Percutaneous Inserted PD Catheters
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End-stage Kidney Disease
- Sponsor
- Universitair Ziekenhuis Brussel
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Outcomes of percutaneous inserted PD catheters in participating centers
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Peritoneal dialysis (PD) is the most frequent modality of home dialysis for patients with kidney failure.
Most PD catheters are placed using a laparoscopic technique. This approach requires the availability of a qualified surgeon, time in the operating theater and general anaesthesia for the patient. Thus, the laparoscopic technique is less suitable for patients with severe heart failure or multimorbidity where general anaesthesia is not possible.
PD catheters can also be inserted using a percutaneous strategy using a modified Seldinger technique. This strategy can be performed bedside under local anaesthesia, by the nephrologist, radiologist, a surgeon, physician assistant or qualified nurse.
The availability of the percutaneous implantation strategy of a PD catheter in a nephrology center may accomodate more patients to receive a PD catheter insertion, including those who have a contraindication to general anaesthesia or need urgent PD.
The PREDICT project aims to increase knowledge and competencies on percutaneous PD catheter insertions by training centers for this technique. By establisching a prospective registry, the outcomes of percutaneously inserted PD catheters, both in experienced and newly trained centers, will be assessed.
Detailed Description
The population of the PREDICT study are adult patients requiring a peritoneal dialysis catheter insertion. Decision for percutaneous strategy of catheter insertion (versus surgical catheter insertion) is made by the treating physician. The inclusion criteria for the prospective PREDICT registry are age \> 18 years and percutaneous PD catheter insertion between 1 March 2023 and 1 March 1 2026 in participating centers. Patients can be included 4 weeks before until 12 weeks after PD catheter insertion. The exclusion criteria are the inability to give informed consent and a life expectancy of less than 3 months. Demographic and clinical data will be collected for all included patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years
- •Percutaneous PD catheter insertion between March 1st 2023 and March 1st 2026 Patients can be included 4 weeks before until 12 weeks after PD catheter insertion
Exclusion Criteria
- •Inability to provide informed consent
- •Life expectancy \< 3 months
Outcomes
Primary Outcomes
Outcomes of percutaneous inserted PD catheters in participating centers
Time Frame: Over 12 months after percutaneous insertion
The second co-primary outcome measure assesses the outcomes of percutaneous inserted PD catheters in participating centers: functionality of PD catheters, defined as catheters usable for PD, over 12 months after percutaneous insertion, and taking into account competing events.
Implementation of percutaneus PD catheter insertion technique in dialysis centers
Time Frame: through study completion, 3 years
The first co-primary outcome measure assesses the implementation of the percutaneous PD catheter insertion technique in additional dialysis centers.
Secondary Outcomes
- The rate of PD utilization(through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch)
- Self-assessed health-related quality of life using the EQ5D questionnaire.(At baseline and at 12 months after percutaneous PD catheter insertion)
- Health-related quality of life as assessed by the SF-12 questionnaire(At baseline and at 12 months after percutaneous PD catheter insertion)
- Insertion-related complications(Perforation during or within 48 hours after catheter insertion, bleeding within 7 days of insertion, and PD-related infections within 30 days of insertion)
- The presence of functioning PD catheter(Over 3 and 6 months after percutaneous PD catheter insertion)
- Health care professionals' perspective on the implementation process(At baseline and yearly)
- Costs of the procedure(immediately after the intervention)
- Mechanical complications(through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch)
- Evolution in HD/PD ratio in participating centers throughout the study period(Through study completion, 3 years)