Chronic Renal Failure
Conditions
Keywords
Automated Peritoneal Dialysis, Adapted APD (aAPD), Hydration status, Residual Renal Function, Ultrafiltration
Brief summary
The aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or improvement of the hydration status of more than 250 PD patients, and to observe the tolerability of the therapy over a long period.
Detailed description
In some studies it has been observed that the use of a combination of short dwell/small volume and long dwell/large volume can improve the effectiveness of APD. However, these studies have been performed in a small number of patients during a short observation period. The aim of this study is to assess the hydration status of PD patients treated with aAPD and observe its development during one year using the BCM-Body Composition Monitor (BCM), a bioimpedance spectroscopy (BIS) device. In addition, it is intended to observe the variability of aAPD prescriptions and their influence on the hydration status of the patients. This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.
Interventions
OTHERTreatment with Adapted Automated Peritoneal Dialysis (aAPD)
This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists
Sponsors
Fresenius Medical Care Deutschland GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* CKD patients with indication for renal replacement therapy * Patient treated or to be treated with aAPD * Fluid status regularly monitored with BCM
Exclusion criteria
* Patients who have any condition prohibiting the use of BCM like patients with major amputations (e.g. lower leg) * Participation in an interventional study which could have an effect on the study objectives hydration status and dialysis adequacy (e.g. studies on PD solutions, studies on diuretics)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hydration status | Every three months during one year | Assessed via body composition measurements |
Secondary
| Measure | Time frame |
|---|---|
| Residual renal function | Every three months during one year |
| Changes in prescription | Every three months during one year |
| Achievement of adequate solute removal | Every three months during one year |
| Therapy tolerability | Every three months during one year |
Other
| Measure | Time frame |
|---|---|
| Change of therapy modality | Every three months during one year |
Countries
Czechia, Denmark, Finland, Malaysia, Spain, Sweden
Outcome results
None listed