NCT06065982

Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT)

Prospective Observational Cohort Study on the Outcomes of Percutaneous Inserted PD Catheters

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• End-stage Kidney Disease

Interventions

Type	Name	Description
OTHER	Questionnaires	Health-related quality of life will be measured using the 12-item Short Form (SF-12) and EQ5D-5L questionnaires. The SF-12 is summarized into two component scores, the Physical Component Score (PCS) and Mental Composite Score (MCS).

Timeline

• Start date: 2023-06-23
• Primary completion: 2026-06-23
• Completion: 2027-06-23
• First posted: 2023-10-04
• Last updated: 2023-10-04

Locations

2 sites across 2 countries: Belgium, Netherlands