Clinical trial NCT06065982: Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT)
Official title: Prospective Observational Cohort Study on the Outcomes of Percutaneous Inserted PD Catheters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End-stage Kidney Disease
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Leiden University Medical Center
name: Bravis Hospital
name: Erasme University Hospital
name: University Hospital, Antwerp
name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: az Glorieux
name: Imelda Hospital, Bonheiden
name: Centre Hospitalier Régional de la Citadelle
name: Rijnstate Hospital
name: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
name: HagaZiekenhuis
name: Bernhoven Hospital
name: Isala
name: Deventer Ziekenhuis
name: Medisch Centrum Leeuwarden
name: OLVG
name: Centro Hospitalar Universitario do Algarve
name: University Medical Centre Ljubljana
First posted: 2023-10-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients requiring a peritoneal dialysis catheter insertion

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.

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

Primary outcomes:
measure: Implementation of percutaneus PD catheter insertion technique in dialysis centers
timeFrame: through study completion, 3 years
measure: Outcomes of percutaneous inserted PD catheters in participating centers
timeFrame: Over 12 months after percutaneous insertion
Secondary outcomes:
measure: The presence of functioning PD catheter
timeFrame: Over 3 and 6 months after percutaneous PD catheter insertion
measure: Insertion-related complications
timeFrame: Perforation during or within 48 hours after catheter insertion, bleeding within 7 days of insertion, and PD-related infections within 30 days of insertion
measure: Mechanical complications
timeFrame: through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch
measure: The rate of PD utilization
timeFrame: through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch
measure: Health-related quality of life as assessed by the SF-12 questionnaire
timeFrame: At baseline and at 12 months after percutaneous PD catheter insertion
measure: Self-assessed health-related quality of life using the EQ5D questionnaire.
timeFrame: At baseline and at 12 months after percutaneous PD catheter insertion
measure: Health care professionals' perspective on the implementation process
timeFrame: At baseline and yearly
measure: Evolution in HD/PD ratio in participating centers throughout the study period
timeFrame: Through study completion, 3 years
measure: Costs of the procedure
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References: