Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT)

NCT06065982 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-10-04

No results posted yet for this study

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.

Conditions

  • End-stage Kidney Disease

Interventions

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).

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER
  • Leiden University Medical Center

    collaborator OTHER
  • Bravis Hospital

    collaborator OTHER
  • Erasme University Hospital

    collaborator OTHER
  • University Hospital, Antwerp

    collaborator OTHER
  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    collaborator OTHER
  • az Glorieux

    collaborator UNKNOWN
  • Imelda Hospital, Bonheiden

    collaborator OTHER
  • Centre Hospitalier Régional de la Citadelle

    collaborator OTHER
  • Rijnstate Hospital

    collaborator OTHER
  • Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

    collaborator OTHER
  • HagaZiekenhuis

    collaborator OTHER
  • Bernhoven Hospital

    collaborator OTHER
  • Isala

    collaborator OTHER
  • Deventer Ziekenhuis

    collaborator OTHER
  • Medisch Centrum Leeuwarden

    collaborator UNKNOWN
  • OLVG

    collaborator NETWORK
  • Centro Hospitalar Universitario do Algarve

    collaborator OTHER
  • University Medical Centre Ljubljana

    collaborator OTHER
  • Universitair Ziekenhuis Brussel

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-23
Primary Completion
2026-06-23
Completion
2027-06-23

Countries

  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06065982 on ClinicalTrials.gov