Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT)

NCT06065982 | Recruiting

• 1 other identifier: UZB-NEF-2023-PREDICT
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 2

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.

Conditions

End-stage Kidney Disease

Outcome Measures

Primary Outcomes (2)

• Implementation of percutaneus PD catheter insertion technique in dialysis centers

  The first co-primary outcome measure assesses the implementation of the percutaneous PD catheter insertion technique in additional dialysis centers.

  through study completion, 3 years

• Outcomes of percutaneous inserted PD catheters in participating centers

  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.

  Over 12 months after percutaneous insertion

Secondary Outcomes (9)

• The presence of functioning PD catheter

  Over 3 and 6 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

• Mechanical complications

  through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch

• The rate of PD utilization

  through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch

• Health-related quality of life as assessed by the SF-12 questionnaire

  At baseline and at 12 months after percutaneous PD catheter insertion

Interventions

Questionnaires OTHER

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients requiring a peritoneal dialysis catheter insertion

You may qualify if:

• 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

You may not qualify if:

• Inability to provide informed consent
• Life expectancy \< 3 months

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• UMC Utrecht: collaborator
• Leiden University Medical Center: collaborator
• Bravis Hospital: collaborator
• Erasme University Hospital: collaborator
• University Hospital, Antwerp: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator
• az Glorieux: collaborator
• Imelda Hospital, Bonheiden: collaborator
• Centre Hospitalier Régional de la Citadelle: collaborator
• Rijnstate Hospital: collaborator
• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC): collaborator
• HagaZiekenhuis: collaborator
• Bernhoven Hospital: collaborator
• Isala: collaborator
• Deventer Ziekenhuis: collaborator
• Medisch Centrum Leeuwarden: collaborator
• OLVG: collaborator
• Centro Hospitalar Universitario do Algarve: collaborator
• University Medical Centre Ljubljana: collaborator

Study Sites (2)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Karlien François, MD PhD

CONTACT

+324776055; Karlien.Francois@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: October 4, 2023
• Study Start: June 23, 2023
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): June 23, 2027
• Last Updated: October 4, 2023

Record last verified: 2023-03

Locations

NL (1); BE (1)