PD-Improved Dialysis Efficiency With Adapted APD
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- CKD patients with indication for renal replacement therapy
- Patient treated or to be treated with aAPD
- Fluid status regularly monitored with BCM
- 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)
Regional Hospital Roskilde
🇫🇮Lappeenranta, Finland
Hospital Selayang
🇲🇾Batu Caves, Malaysia
Hospital Universiti Kebangsaan Malaysia (HUKM)
🇲🇾Kuala Lumpur, Malaysia
Hospital Seremban
🇲🇾Seremban, Malaysia
Faculty Hospital Brno-Bohunice
🇨🇿Brno, Czechia
Gleneagles Hospital Kuala Lumpur (GHKL)
🇲🇾Kuala Lumpur, Malaysia
Hospital General de Castellón
🇪🇸Castellón De La Plana, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Serdang
🇲🇾Serdang, Malaysia
Fundación Hospital de Alcorcón
🇪🇸Alcorcón, Spain
Hospital de Basurto
🇪🇸Bilbao, Spain
Complejo Hospitalario universitario de Albacete
🇪🇸Albacete, Spain
Fundacion Puigvert
🇪🇸Barcelona, Spain
Hospital Universitario di Girona Josep Trueta
🇪🇸Girona, Spain
Hospital General Virgen de las Nieves
🇪🇸Granada, Spain
Complejo hospitalario de Jaén
🇪🇸Jaén, Spain
Complejo Hospitalario San Millán-San Pedro De La Rioja
🇪🇸Logroño, Spain
Hospital Universitario Lucus Agusti
🇪🇸Lugo, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitatio Donostia
🇪🇸San Sebastián, Spain
Hospital Universitario Central de Asturias (HUCA)
🇪🇸Oviedo, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Hospital Peset
🇪🇸Valencia, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
Hospital Txagorritxu
🇪🇸Vitoria, Spain
Complejo Asistencial de Avila
🇪🇸Ávila, Spain
Danderyds Sjukhus AB
🇸🇪Danderyd, Sweden
Höglandssjukhuset Eksjö/Nässjö
🇸🇪Eksjö, Sweden
Länssjukhuset Sundsvall
🇸🇪Sundsvall, Sweden
Kalmar Hospital
🇸🇪Kalmar, Sweden
Skåne University Hospital
🇸🇪Lund, Sweden
Norra Älvsborgs Länssjukhus
🇸🇪Trollhättan, Sweden
Norrlands University Hopsital
🇸🇪Umeå, Sweden
Regional Hospital Viborg
🇩🇰Viborg, Denmark
NC centre Sokolov
🇨🇿Sokolov, Czechia
Faculty Hospital Strahov
🇨🇿Prague, Czechia
Kymenlaakso Central Hospital
🇫🇮Kotka, Finland
Hospital Nove Mesto na Morave
🇨🇿Nove Mesto na Morave, Czechia
Regional Hospital in Mlada Boleslav
🇨🇿Mlada Boleslav, Czechia
Hospital Liberec
🇨🇿Liberec, Czechia
Helsinki University Hospital
🇫🇮Helsinki, Finland
Faculty Hospital Pilsen
🇨🇿Pilsen, Czechia
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Spain
Hospital Carlos Haya
🇪🇸Málaga, Spain
Complejo Hospital Universitario de Santiago (CHUS)
🇪🇸Santiago De Compostela, Spain
Faculty Hospital Karlovo namesti
🇨🇿Prague, Czechia
NC centre Vinohrady
🇨🇿Prague, Czechia
Hospital Trebic
🇨🇿Trebic, Czechia
Complexo Hospitalario Universitario de Ourense (CHUO)
🇪🇸Ourense, Spain