Chronic Renal Failure
Conditions
Keywords
Peritoneal dialysis, Hydration status, Residual renal function, Bioimpedance spectroscopy, Body composition monitor
Brief summary
The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD) patients and its evolution over a period of four years, independent of the PD treatment modality (APD or CAPD) and the PD solution type.
Detailed description
Achieving optimal fluid balance remains a major clinical challenge in peritoneal dialysis (PD) patients. With the recent development of a new bioimpedance spectroscopy (BIS) device, the BCM-Body Composition Monitor (BCM), it is now possible to quantify deviations of hydration status and to define target weight directly. It has been observed that more than 50% of the PD patients are overhydrated, as compared to the healthy population. This overhydration seems to be associated with modifiable practice-related factors, such as correct PD prescription according to membrane transport status, and dietary fluid intake. The aim of this study is to assess the hydration status of incident PD patients, and diagnose the underlying reasons for incorrect fluid status. In addition, changes in fluid status, residual renal function and nutritional status, over a follow-up period of up to four years will be registered. The investigators assume that the use of the BCM-Body Composition Monitor (BCM) provides quantitative measurement of hydration status and thereby supports physicians in identifying patients who are not euvolaemic. Hence, the BCM allows an improved management of underlying causes of non-euvolaemic hydration state and appropriate monitoring of fluid status.
Interventions
OTHERNon-interventional study
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
* Incident patients directly before start of peritoneal dialysis * Patients in whom routine measurement of body composition monitoring is performed
Exclusion criteria
* Patients treated with HD before start of PD * Patients in whom body composition monitoring cannot be performed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hydration status | Every three months over a period of four years | Assessed via body composition measurements (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW)) (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW)) |
Secondary
| Measure | Time frame |
|---|---|
| Residual renal function | Every three months over a period of four years |
| Peritoneal transport status | Every three months over a period of four years |
| Time to change to haemodialysis | Four years |
| Changes in PD prescription | Four years |
Countries
Austria, Belgium, Bosnia and Herzegovina, Brazil, Croatia, Cuba, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, Venezuela
Outcome results
None listed