An observational study in Chronic Renal Failure, sponsored by Fresenius Medical Care Deutschland GmbH. Completed at 134 sites in 28 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-02.
Sponsored by Fresenius Medical Care Deutschland GmbH (part of Fresenius Medical Care) · Observational
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.
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 1,092 is above the median of 120 across 442 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Fresenius Medical Care Deutschland GmbH is the lead sponsor of 36 studies on the registry; 7 are open to participants now.
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Adult patients with chronic kidney disease (CKD) starting renal replacement therapy on APD or CAPD
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Exclusion Criteria:
This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.
Hydration status
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))
Time frame: Every three months over a period of four years
Residual renal function
Time frame: Every three months over a period of four years
Peritoneal transport status
Time frame: Every three months over a period of four years
Time to change to haemodialysis
Time frame: Four years
Changes in PD prescription
Time frame: Four years
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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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