End Stage Renal Disease, Renal Failure
Conditions
Keywords
Peritoneal dialysis, Automated peritoneal dialysis (APD), PD cyler, Renal replacement therapy
Brief summary
The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler which are both well-established PD cyclers.
Interventions
DEVICEPD cycler Silencia
Treatment for 2 weeks either with PD-Night or Homechoice PD cycler (Comparators) depending on the previous Treatment ((clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II).
Sponsors
Winicker Norimed GmbH
James Motta, Clinical Research Associate (CRA)
Fresenius Medical Care Deutschland GmbH
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, controlled, multicentre, interventional
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent signed and dated by study patient and investigator/authorised physician * CKD patients being treated with APD for at least 3 months * Minimum age of 18 years * Body weight ≥ 40 kg * Fluid status regularly monitored with Body Composition Monitor (BCM) * Patients planned to change to the Silencia PD cycler * Proper functioning catheter * Intraperitoneal Pressure (IPP) ≤ 18 cm H2O for the maximum of TAVO parameter permitted patient volume * Ability to understand the nature and requirements of the study
Exclusion criteria
* Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg) * Patients receiving polyglucose containing PD solution * Any conditions which could interfere with the patient's ability to comply with the study * Patients who suffer from peritonitis/exit site infection during the last 4 weeks * Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period * Life expectancy \< 3 months * Participation in an interventional clinical study during the preceding 30 days * Previous participation in the same study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Kt/V urea | at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days) | Measurement of solute removal during peritoneal dialysis focuses on urea |
| Achieving Kt/Vurea ≥ 1.7 | at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days) | Measurement of solute removal during peritoneal dialysis focuses on urea |
| Mean daily ultrafiltration (UF) | at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days) | Daily ultrafiltration reached by the Patient with APD |
Countries
Chile
Outcome results
None listed