Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)|
- Hydration status [ Time Frame: Every three months over a period of four years ] [ Designated as safety issue: No ]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))
- Residual renal function [ Time Frame: Every three months over a period of four years ] [ Designated as safety issue: No ]
- Peritoneal transport status [ Time Frame: Every three months over a period of four years ] [ Designated as safety issue: No ]
- Time to change to haemodialysis [ Time Frame: Four years ] [ Designated as safety issue: No ]
- Changes in PD prescription [ Time Frame: Four years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
|ESRD patients treated with PD||
Other: Non-interventional study
This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.
Other Name: Observational study
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285726
Show 135 Study Locations
|Study Chair:||Claudio Ronco, Prof||Ospedale San Bartolo|
|Study Chair:||Wim Van Biesen, Prof||Ghent University Hospital|
|Study Chair:||Christian Verger, Dr||Centre Hospitalier René Dubos|
|Study Chair:||John Williams, Prof||University Hospital of Wales|