PD Catheter Data Collection
ConditionRenal Insufficiency / Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFresenius Medical Care Deutschland GmbH
About this trial
Peritoneal Dialysis (PD) is a Renal Replacement Therapy for patients with renal insufficiency that has been used more frequently in recent years. In PD treatment, catheter are used to provide access to the peritoneal cavity, allowing the dialysate to be introduced and removed from the abdomen. The aim of this study is to evaluate the safety and efficacy of long-term treatment with PD catheters (developed by Fresenius Medical Care (FME)) in adult and paediatric patients treated with CAPD or APD. Safety and performance parameters of the catheters will be analyzed, as well as data on PD treatment outcome, such as Peritoneal Clearance and Peritoneal Ultrafiltration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed and dated informed consent for study participation and data submission (by the patient or legal representative for patients under 18) along with investigator/authorized physician signature.
Patients under 18 who have received age- and maturity-appropriate information per Article 63(2) MDR from trained investigators or team members; minors capable of understanding must also sign the informed consent.
The investigator must respect the decision of any minor, capable of understanding the information as per Article 63(2) MDR, to decline participation or withdraw from the clinical investigation at any time.
Ability to understand the nature and requirements of the study.
Disqualifiers
Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations,
Previous participation in the same study.
Life expectancy < 3 months.
Trial population
All the patients treated with peritoneal dialysis (PD or APD) using the PD catheter as described and who who will begin PD, or patients who began PD within the last 1.5 years before start of the study
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: PD treatment
Trial outcomes
Primary outcomes
1
Safety variables
Catheter related infections (e.g. peritonitis, tunnel infections, exit site infection)
Time frame
Every 6 months (± 2 months, as per centre practice)2
Safety variables
Non-infectious complications
Time frame
Every 6 months (± 2 months, as per centre practice)3
Safety variables
Biocompatibility (allergic reaction)
Time frame
Every 6 months (± 2 months, as per centre practice)4
Safety variables
Identify new emerging risks
Time frame
Every 6 months (± 2 months, as per centre practice)Secondary outcomes
1
Performance variables
Catheter patency
Time frame
very 6 months (± 2 months, as per centre practice)2
Performance variables
Non-infectious complication
Time frame
very 6 months (± 2 months, as per centre practice)3
Outcome variables
Peritoneal clearance
Time frame
very 6 months (± 2 months, as per centre practice)4
Outcome variables
Peritoneal UF
Time frame
very 6 months (± 2 months, as per centre practice)Sponsors and contacts
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Source ClinicalTrials.gov