PD-Improved Dialysis Efficiency With Adapted APD

Completed

• Conditions: Chronic Renal Failure

• Registration Number: NCT02470598
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

Brief Summary

The aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or improvement of the hydration status of more than 250 PD patients, and to observe the tolerability of the therapy over a long period.

Detailed Description

In some studies it has been observed that the use of a combination of short dwell/small volume and long dwell/large volume can improve the effectiveness of APD. However, these studies have been performed in a small number of patients during a short observation period.

The aim of this study is to assess the hydration status of PD patients treated with aAPD and observe its development during one year using the BCM-Body Composition Monitor (BCM), a bioimpedance spectroscopy (BIS) device. In addition, it is intended to observe the variability of aAPD prescriptions and their influence on the hydration status of the patients.

This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-12
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-08-05
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• CKD patients with indication for renal replacement therapy
• Patient treated or to be treated with aAPD
• Fluid status regularly monitored with BCM

Exclusion Criteria

• Patients who have any condition prohibiting the use of BCM like patients with major amputations (e.g. lower leg)
• Participation in an interventional study which could have an effect on the study objectives hydration status and dialysis adequacy (e.g. studies on PD solutions, studies on diuretics)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hydration status	Every three months during one year	Assessed via body composition measurements

Secondary Outcome Measures

Name	Time	Method
Residual renal function	Every three months during one year
Changes in prescription	Every three months during one year
Achievement of adequate solute removal	Every three months during one year
Therapy tolerability	Every three months during one year

Trial Locations

Locations (50)

Faculty Hospital Brno-Bohunice; 🇨🇿 Brno, Czechia

Hospital Liberec; 🇨🇿 Liberec, Czechia

Regional Hospital in Mlada Boleslav; 🇨🇿 Mlada Boleslav, Czechia

Hospital Nove Mesto na Morave; 🇨🇿 Nove Mesto na Morave, Czechia

Faculty Hospital Pilsen; 🇨🇿 Pilsen, Czechia

Faculty Hospital Karlovo namesti; 🇨🇿 Prague, Czechia

Faculty Hospital Strahov; 🇨🇿 Prague, Czechia

NC centre Vinohrady; 🇨🇿 Prague, Czechia

NC centre Sokolov; 🇨🇿 Sokolov, Czechia

Hospital Trebic; 🇨🇿 Trebic, Czechia

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