End-stage Kidney DiseasePREDICTNCT06065982
Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT)
An observational study of End-stage Kidney Disease, run by Universitair Ziekenhuis Brussel at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Kidney Disease
- What is being tested?
- Questionnaires
- How many people
- 500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Jun 2023to 23 Jun 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients requiring a peritoneal dialysis catheter insertion
Who may be able to join
- 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
Who cannot join
- Inability to provide informed consent
- Life expectancy < 3 months
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Karlien François, MD PhD, Karlien.Francois@uzbrussel.be
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht
Alferso C Abrahams, MD PhD, A.C.Abrahams@umcutrecht.nl
About this study
Official title: Prospective Observational Cohort Study on the Outcomes of Percutaneous Inserted PD Catheters
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.
Read more
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.
Read the 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.
- Conditions
- End-stage Kidney Disease
- Being tested
- Questionnaires
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Over 12 months after percutaneous insertion
Secondary outcomes (9)
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.
Measured: Over 3 and 6 months after percutaneous PD catheter insertion
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.
Measured: 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
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.
Measured: through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch
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.
Measured: 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
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.
Measured: At baseline and at 12 months after percutaneous PD catheter insertion
Self-assessed health-related quality of life using the EQ5D questionnaire.
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.
Measured: At baseline and at 12 months after percutaneous PD catheter insertion
Health care professionals' perspective on the implementation process
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.
Measured: At baseline and yearly
Evolution in HD/PD ratio in participating centers throughout the study period
This secondary outcome assesses the evolution in HD/PD ratio in participating centers throughout the study period.
Measured: Through study completion, 3 years
Costs of the procedure
The secondary outcome assesses the costs of the procedure.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start23 Jun 2023
- Primary completion23 Jun 2026 (estimated)
- Study completion23 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Leiden University Medical Center, Bravis Hospital, Erasme University Hospital, University Hospital, Antwerp, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, az Glorieux, Imelda Hospital, Bonheiden, Centre Hospitalier Régional de la Citadelle, Rijnstate Hospital, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), HagaZiekenhuis, Bernhoven Hospital, Isala, Deventer Ziekenhuis, Medisch Centrum Leeuwarden, OLVG, Centro Hospitalar Universitario do Algarve, University Medical Centre Ljubljana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065982
- Sponsor's protocol ID
- UZB-NEF-2023-PREDICT
- Acronym
- PREDICT
- Status last verified
- Mar 2023
- First submitted
- 28 Apr 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Cohort Study on the Outcomes of Percutaneous Inserted PD Catheters
- ClinicalTrials.gov ID
- NCT06065982
- Acronym / sponsor ID
- PREDICT / UZB-NEF-2023-PREDICT
- Conditions
- End-stage Kidney Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- UMC Utrecht, Leiden University Medical Center, Bravis Hospital, Erasme University Hospital, University Hospital, Antwerp, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, az Glorieux, Imelda Hospital, Bonheiden, Centre Hospitalier Régional de la Citadelle, Rijnstate Hospital, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), HagaZiekenhuis, Bernhoven Hospital, Isala, Deventer Ziekenhuis, Medisch Centrum Leeuwarden, OLVG, Centro Hospitalar Universitario do Algarve, University Medical Centre Ljubljana
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 23 Jun 2026 (estimated)
- Study completion
- 23 Jun 2027 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients requiring a peritoneal dialysis catheter insertion
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Life expectancy < 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesHealth-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). | Other | – |
Primary outcome
Implementation of percutaneus PD catheter insertion technique in dialysis centers
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.
Outcomes of percutaneous inserted PD catheters in participating 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.
9 secondary outcomes
The presence of functioning PD catheter
Time frame: Over 3 and 6 months after percutaneous PD catheter insertion
Insertion-related complications
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
Mechanical complications
Time frame: through study completion of the subject, at 1 year or censored for death or kidney replacement modality switch
The rate of PD utilization
Time frame: 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
Time frame: At baseline and at 12 months after percutaneous PD catheter insertion
Self-assessed health-related quality of life using the EQ5D questionnaire.
Time frame: At baseline and at 12 months after percutaneous PD catheter insertion
Health care professionals' perspective on the implementation process
Time frame: At baseline and yearly
Evolution in HD/PD ratio in participating centers throughout the study period
Time frame: Through study completion, 3 years
Costs of the procedure
Time frame: immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
Related trials for End-stage Kidney Disease
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Active, not recruitingObservational study
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Kidney Disease, run by Universitair Ziekenhuis Brussel at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karlien François, MD PhD (+324776055, Karlien.Francois@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation of percutaneus PD catheter insertion technique in dialysis centers (time frame: through study completion, 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.