Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study) (IPOD-PD)
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|ClinicalTrials.gov Identifier: NCT01285726|
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : May 2, 2016
|Condition or disease||Intervention/treatment|
|Chronic Renal Failure||Other: Non-interventional 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.
|Study Type :||Observational|
|Actual Enrollment :||1092 participants|
|Official Title:||Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
- 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.
- Hydration status [ Time Frame: 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))
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285726
Show 134 Study Locations
|Study Chair:||Claudio Ronco, Prof||Ospedale San Bartolo|
|Study Chair:||Wim Van Biesen, Prof||University Hospital, Ghent|
|Study Chair:||Christian Verger, Dr||French Language PD Registry (RDPLF)|