Klinikum Dortmund gGmbH
Dortmund, 44137, Germany
NCT Number: NCT07156123
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.
Trial opening soon.
Get NotifiedAll sexes
Observational
Dortmund, 44137, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Every 6 months (± 2 months, as per centre practice)
Catheter related infections (e.g. peritonitis, tunnel infections, exit site infection)
Time frame: Every 6 months (± 2 months, as per centre practice)
Non-infectious complications
Time frame: Every 6 months (± 2 months, as per centre practice)
Biocompatibility (allergic reaction)
Time frame: Every 6 months (± 2 months, as per centre practice)
Identify new emerging risks
Time frame: Every 6 months (± 2 months, as per centre practice)
Monitor side effects
Time frame: Every 6 months (± 2 months, as per centre practice)
Catheter removal
Time frame: very 6 months (± 2 months, as per centre practice)
Catheter patency
Time frame: very 6 months (± 2 months, as per centre practice)
Non-infectious complication
Time frame: very 6 months (± 2 months, as per centre practice)
Peritoneal clearance
Time frame: very 6 months (± 2 months, as per centre practice)
Peritoneal UF
Time frame: very 6 months (± 2 months, as per centre practice)
Mechanical complications
Time frame: very 6 months (± 2 months, as per centre practice)
Therapy tolerability.
Contact information is provided by the study sponsor or research team.
Celina Meyer
CONTACT
Fiona Bellando
CONTACT
Fresenius Medical Care Deutschland GmbH
Industry
Analysis of Safety and Efficacy of Long-term Treatment With PD Catheters
Acronym: Catheter
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.
Published trials that share one or more normalized conditions with this study.
NCT07715175
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Hefei, Anhui, China
View Trial DetailsNCT07679568
Acute Kidney Injury, Female Urogenital Diseases
Munich, Bavaria, Germany
View Trial DetailsNCT07636083
Acute Kidney Injury, Digestive System Diseases
Sohag, Egypt
View Trial DetailsNCT07618858
Chronic Disease, Chronic Hemodialysis
Ljubljana, Slovenia
View Trial Details