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

Completed

• Conditions: Chronic Renal Failure

• Registration Number: NCT01285726
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-28
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1092

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in PD prescription	Four years
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

Trial Locations

Locations (134)

Klinikum Wels; 🇦🇹 Wels, Austria

ASZ Aalst; 🇧🇪 Aalst, Belgium

Ghent University Hospital; 🇧🇪 Gent, Belgium

ASZ Geraardsbergen; 🇧🇪 Geraardsbergen, Belgium

U.Z. Leuven; 🇧🇪 Leuven, Belgium

CHU Sart Tilman; 🇧🇪 Liège, Belgium

Heilig-Hart Roeselare; 🇧🇪 Roeselare, Belgium

KBC Mostar; 🇧🇦 Mostar, Bosnia and Herzegovina

UKC Tuzla; 🇧🇦 Tuzla, Bosnia and Herzegovina

Instituto Mineiro Nefrologia; 🇧🇷 Belo Horizonte, Brazil

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