Clinical trial NCT02470598: PD-Improved Dialysis Efficiency With Adapted APD
Official title: PD-Improved Dialysis Efficiency With Adapted APD - PD-IDEA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Failure
Keywords: Automated Peritoneal Dialysis
Adapted APD (aAPD)
Hydration status
Residual Renal Function
Ultrafiltration
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease (CKD) being treated or starting renal replacement therapy with aAPD

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Hydration status
timeFrame: Every three months during one year
Secondary outcomes:
measure: Residual renal function
timeFrame: Every three months during one year
measure: Changes in prescription
timeFrame: Every three months during one year
measure: Achievement of adequate solute removal
timeFrame: Every three months during one year
measure: Therapy tolerability
timeFrame: Every three months during one year
Other outcomes:
measure: Change of therapy modality
timeFrame: Every three months during one year
Locations:
city: Brno
country: Czechia
facility: Faculty Hospital Brno-Bohunice
city: Liberec
country: Czechia
facility: Hospital Liberec
city: Mlada Boleslav
country: Czechia
facility: Regional Hospital in Mlada Boleslav
city: Nove Mesto na Morave
country: Czechia
facility: Hospital Nove Mesto na Morave
city: Pilsen
country: Czechia
facility: Faculty Hospital Pilsen
city: Prague
country: Czechia
facility: Faculty Hospital Karlovo namesti
city: Prague
country: Czechia
facility: Faculty Hospital Strahov
city: Prague
country: Czechia
facility: NC centre Vinohrady
city: Sokolov
country: Czechia
facility: NC centre Sokolov
city: Trebic
country: Czechia
facility: Hospital Trebic
city: Viborg
country: Denmark
facility: Regional Hospital Viborg
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Kotka
country: Finland
facility: Kymenlaakso Central Hospital
city: Lappeenranta
country: Finland
facility: Regional Hospital Roskilde
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: Kuala Lumpur
country: Malaysia
facility: Gleneagles Hospital Kuala Lumpur (GHKL)
city: Kuala Lumpur
country: Malaysia
facility: Hospital Universiti Kebangsaan Malaysia (HUKM)
city: Serdang
country: Malaysia
facility: Hospital Serdang
city: Seremban
country: Malaysia
facility: Hospital Seremban
city: Albacete
country: Spain
facility: Complejo Hospitalario universitario de Albacete
city: Alcorcón
country: Spain
facility: Fundación Hospital de Alcorcón
city: Barcelona
country: Spain
facility: Fundacion Puigvert
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Castellón De La Plana
country: Spain
facility: Hospital General de Castellón
city: Girona
country: Spain
facility: Hospital Universitario di Girona Josep Trueta
city: Granada
country: Spain
facility: Hospital General Virgen de las Nieves
city: Jaén
country: Spain
facility: Complejo hospitalario de Jaén
city: Logroño
country: Spain
facility: Complejo Hospitalario San Millán-San Pedro De La Rioja
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Agusti
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense (CHUO)
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias (HUCA)
city: San Sebastián
country: Spain
facility: Hospital Universitatio Donostia
city: Santiago De Compostela
country: Spain
facility: Complejo Hospital Universitario de Santiago (CHUS)
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital Peset
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
city: Ávila
country: Spain
facility: Complejo Asistencial de Avila
city: Danderyd
country: Sweden
facility: Danderyds Sjukhus AB
city: Eksjö
country: Sweden
facility: Höglandssjukhuset Eksjö/Nässjö
city: Kalmar
country: Sweden
facility: Kalmar Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Sundsvall
country: Sweden
facility: Länssjukhuset Sundsvall
city: Trollhättan
country: Sweden
facility: Norra Älvsborgs Länssjukhus
city: Umeå
country: Sweden
facility: Norrlands University Hopsital
Study officials:
affiliation: University Hospital Hautepierre
name: Michel Fischbach, Prof.
role: STUDY_DIRECTOR
affiliation: Hospital Clinic i Provinvial de Barcelona
name: Manel Vera, Dr.
role: STUDY_DIRECTOR
affiliation: Ospedale "Treviglio-Caravaggio" di Treviglio
name: Emilio Galli, Dr.
role: STUDY_DIRECTOR
affiliation: University Hospotal Besancon
name: Cecile Courivaud, Dr.
role: STUDY_DIRECTOR
affiliation: Helsinki Univerity Hospital
name: Virpi Rauta, Dr.
role: STUDY_DIRECTOR
References: