Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT)
ConditionEnd-stage Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to provide informed consent
Life expectancy < 3 months
Trial population
Adult patients requiring a peritoneal dialysis catheter insertion
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Questionnaires
Other interventionHealth-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).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
through study completion, 3 years2
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.
Time frame
Over 12 months after percutaneous insertionSecondary outcomes
1
The presence of functioning PD catheter
This secondary outcome measure assesses the presence of functioning PD catheter, defined as catheters usable for PD, over 3 and 6 months after percutaneous PD catheter insertion, censored for competing events.
Time frame
Over 3 and 6 months after percutaneous PD catheter insertion2
Insertion-related complications
This secondary outcome measure assesses insertion-related complications, defined as perforation during or within 48 hours after catheter insertion, bleeding within 7 days of insertion and necessitating blood transfusion and/or invasive intervention to control bleeding, and PD-related infections (i.e. exit-site infection, tunnel infection, peritonitis) within 30 days of insertion.
Time frame
Perforation during or within 48 hours after catheter insertion, bleeding within 7 days of insertion, and PD-related infections within 30 days of insertion3
Mechanical complications
This secondary outcome measure assesses mechanical complications over 3, 6, and 12 months after percutaneous PD catheter insertion. Relevant mechanical complications are defined as flow restrictions, pericatheter leakage, and abdominal pain resulting in an adverse event that is either a lack of PD start, a delay in PD start, an interruption of PD, a permanent termination of PD, emergency room visits, hospital admissions, or need for invasive procedures related to the mechanical catheter complication.
Time frame
through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch4
The rate of PD utilization
This secondary outcome measure assesses the rate of PD utilization, defined as 4 consecutive weeks of PD, after percutaneous PD catheter insertion, censored for competing events.
Time frame
through study completion of the subject, at 1 year or censored for death or kidney replacement modality switchSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitair Ziekenhuis Brussel
Lead sponsor
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
Source ClinicalTrials.gov