Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)

Conditions
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Chronic Renal Failure

Intervention / Treatment
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* Other: Non-interventional study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)) | Every three months over a period of four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal dialysis, Hydration status, Residual renal function, Bioimpedance spectroscopy, Body composition monitor