PD-IDEA: PD-Improved Dialysis Efficiency With Adapted APD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Outcome Measures
Primary Outcome Measures
- Hydration status [Every three months during one year]
Assessed via body composition measurements
Secondary Outcome Measures
- 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]
Other Outcome Measures
- Change of therapy modality [Every three months during one year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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CKD patients with indication for renal replacement therapy
-
Patient treated or to be treated with aAPD
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Fluid status regularly monitored with BCM
Exclusion Criteria:
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Patients who have any condition prohibiting the use of BCM like patients with major amputations (e.g. lower leg)
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty Hospital Brno-Bohunice | Brno | Czechia | ||
| 2 | Hospital Liberec | Liberec | Czechia | ||
| 3 | Regional Hospital in Mlada Boleslav | Mlada Boleslav | Czechia | ||
| 4 | Hospital Nove Mesto na Morave | Nove Mesto na Morave | Czechia | ||
| 5 | Faculty Hospital Pilsen | Pilsen | Czechia | ||
| 6 | Faculty Hospital Karlovo namesti | Prague | Czechia | ||
| 7 | Faculty Hospital Strahov | Prague | Czechia | ||
| 8 | NC centre Vinohrady | Prague | Czechia | ||
| 9 | NC centre Sokolov | Sokolov | Czechia | ||
| 10 | Hospital Trebic | Trebic | Czechia | ||
| 11 | Regional Hospital Viborg | Viborg | Denmark | ||
| 12 | Helsinki University Hospital | Helsinki | Finland | ||
| 13 | Kymenlaakso Central Hospital | Kotka | Finland | ||
| 14 | Regional Hospital Roskilde | Lappeenranta | Finland | ||
| 15 | Hospital Selayang | Batu Caves | Malaysia | ||
| 16 | Gleneagles Hospital Kuala Lumpur (GHKL) | Kuala Lumpur | Malaysia | ||
| 17 | Hospital Universiti Kebangsaan Malaysia (HUKM) | Kuala Lumpur | Malaysia | ||
| 18 | Hospital Serdang | Serdang | Malaysia | ||
| 19 | Hospital Seremban | Seremban | Malaysia | ||
| 20 | Complejo Hospitalario universitario de Albacete | Albacete | Spain | ||
| 21 | Fundación Hospital de Alcorcón | Alcorcón | Spain | ||
| 22 | Fundacion Puigvert | Barcelona | Spain | ||
| 23 | Hospital Clinic de Barcelona | Barcelona | Spain | ||
| 24 | Hospital de Basurto | Bilbao | Spain | ||
| 25 | Hospital General de Castellón | Castellón De La Plana | Spain | ||
| 26 | Hospital Universitario di Girona Josep Trueta | Girona | Spain | ||
| 27 | Hospital General Virgen de las Nieves | Granada | Spain | ||
| 28 | Complejo hospitalario de Jaén | Jaén | Spain | ||
| 29 | Complejo Hospitalario San Millán-San Pedro De La Rioja | Logroño | Spain | ||
| 30 | Hospital Universitario Lucus Agusti | Lugo | Spain | ||
| 31 | Hospital Clínico San Carlos | Madrid | Spain | ||
| 32 | Hospital Universitario Ramón y Cajal | Madrid | Spain | ||
| 33 | Hospital Universitario Puerta de Hierro | Majadahonda | Spain | ||
| 34 | Hospital Carlos Haya | Málaga | Spain | ||
| 35 | Complexo Hospitalario Universitario de Ourense (CHUO) | Ourense | Spain | ||
| 36 | Hospital Universitario Central de Asturias (HUCA) | Oviedo | Spain | ||
| 37 | Hospital Universitatio Donostia | San Sebastián | Spain | ||
| 38 | Complejo Hospital Universitario de Santiago (CHUS) | Santiago De Compostela | Spain | ||
| 39 | Hospital Clínico de Valencia | Valencia | Spain | ||
| 40 | Hospital Peset | Valencia | Spain | ||
| 41 | Hospital Universitari i Politècnic La Fe | Valencia | Spain | ||
| 42 | Hospital Txagorritxu | Vitoria | Spain | ||
| 43 | Complejo Asistencial de Avila | Ávila | Spain | ||
| 44 | Danderyds Sjukhus AB | Danderyd | Sweden | ||
| 45 | Höglandssjukhuset Eksjö/Nässjö | Eksjö | Sweden | ||
| 46 | Kalmar Hospital | Kalmar | Sweden | ||
| 47 | Skåne University Hospital | Lund | Sweden | ||
| 48 | Länssjukhuset Sundsvall | Sundsvall | Sweden | ||
| 49 | Norra Älvsborgs Länssjukhus | Trollhättan | Sweden | ||
| 50 | Norrlands University Hopsital | Umeå | Sweden |
Sponsors and Collaborators
- Fresenius Medical Care Deutschland GmbH
Investigators
- Study Director: Michel Fischbach, Prof., University Hospital Hautepierre
- Study Director: Manel Vera, Dr., Hospital Clinic i Provinvial de Barcelona
- Study Director: Emilio Galli, Dr., Ospedale "Treviglio-Caravaggio" di Treviglio
- Study Director: Cecile Courivaud, Dr., University Hospotal Besancon
- Study Director: Virpi Rauta, Dr., Helsinki Univerity Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PD-aAPD-01-INT