NCT Number: NCT06065982
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Universitair Ziekenhuis Brussel, Brussels, Belgium
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: through study completion, 3 years
The first co-primary outcome measure assesses the implementation of the percutaneous PD catheter insertion technique in additional dialysis centers.
Time frame: Over 12 months after percutaneous insertion
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 3 and 6 months after percutaneous PD catheter insertion
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: Perforation during or within 48 hours after catheter insertion, bleeding within 7 days of insertion, and PD-related infections within 30 days of insertion
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: through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch
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 switch
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: At baseline and at 12 months after percutaneous PD catheter insertion
This secondary outcome is assesses health-related quality of life using patient-reported outcome measures (PROMs) at baseline and at 12 months after percutaneous PD catheter insertion, using the validated SF-12 questionnaire.
Time frame: At baseline and at 12 months after percutaneous PD catheter insertion
This secondary outcome is assesses health-related quality of life in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using the validated EQ5D questionnaire.
Time frame: At baseline and yearly
This secondary outcome assesses the health care professionals' perspective on the implementation process using the structured Measurement Instrument for Determinants of Innovations. This assessment allows to identify barriers and facilitators of implementation at the level of the percutaneous catheter insertion procedure, at the level of the operator and at the level of the organisation, i.e. the hospital.
Time frame: Through study completion, 3 years
This secondary outcome assesses the evolution in HD/PD ratio in participating centers throughout the study period.
Time frame: immediately after the intervention
The secondary outcome assesses the costs of the procedure.
Contact information is provided by the study sponsor or research team.
Universitair Ziekenhuis Brussel
Other
Prospective Observational Cohort Study on the Outcomes of Percutaneous Inserted PD Catheters
Acronym: PREDICT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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