Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
182 participants
OBSERVATIONAL
2015-03-31
2020-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)
NCT01285726
Assisted Peritoneal Dialysis: A Feasibility Study
NCT04319185
A Prospective, Open-label, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA
NCT05342935
The Clinical Effects of Korean Adapted APD in Automated Peritoneal Dialysis Patients
NCT01997385
The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
NCT01753154
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Treatment with Adapted Automated Peritoneal Dialysis (aAPD)
This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient treated or to be treated with aAPD
* Fluid status regularly monitored with BCM
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fresenius Medical Care Deutschland GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michel Fischbach, Prof.
Role: STUDY_DIRECTOR
University Hospital Hautepierre
Manel Vera, Dr.
Role: STUDY_DIRECTOR
Hospital Clinic i Provinvial de Barcelona
Emilio Galli, Dr.
Role: STUDY_DIRECTOR
Ospedale "Treviglio-Caravaggio" di Treviglio
Cecile Courivaud, Dr.
Role: STUDY_DIRECTOR
University Hospotal Besancon
Virpi Rauta, Dr.
Role: STUDY_DIRECTOR
Helsinki Univerity Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty Hospital Brno-Bohunice
Brno, , Czechia
Hospital Liberec
Liberec, , Czechia
Regional Hospital in Mlada Boleslav
Mladá Boleslav, , Czechia
Hospital Nove Mesto na Morave
Nové Město na Moravě, , 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
Třebíč, , Czechia
Regional Hospital Viborg
Viborg, , Denmark
Helsinki University Hospital
Helsinki, , Finland
Kymenlaakso Central Hospital
Kotka, , Finland
Regional Hospital Roskilde
Lappeenranta, , Finland
Hospital Selayang
Batu Caves, , Malaysia
Gleneagles Hospital Kuala Lumpur (GHKL)
Kuala Lumpur, , Malaysia
Hospital Universiti Kebangsaan Malaysia (HUKM)
Kuala Lumpur, , Malaysia
Hospital Serdang
Serdang, , Malaysia
Hospital Seremban
Seremban, , Malaysia
Complejo Hospitalario universitario de Albacete
Albacete, , Spain
Fundación Hospital de Alcorcón
Alcorcón, , Spain
Complejo Asistencial de Avila
Ávila, , Spain
Fundacion Puigvert
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de Basurto
Bilbao, , Spain
Hospital General de Castellón
Castellon, , 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 Universitario Puerta de Hierro
Majadahonda, , Spain
Hospital Carlos Haya
Málaga, , Spain
Complexo Hospitalario Universitario de Ourense (CHUO)
Ourense, , Spain
Hospital Universitario Central de Asturias (HUCA)
Oviedo, , Spain
Hospital Universitatio Donostia
San Sebastián, , Spain
Complejo Hospital Universitario de Santiago (CHUS)
Santiago de Compostela, , Spain
Hospital Clínico de Valencia
Valencia, , Spain
Hospital Peset
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Hospital Txagorritxu
Vitoria-Gasteiz, , Spain
Danderyds Sjukhus AB
Danderyd, , Sweden
Höglandssjukhuset Eksjö/Nässjö
Eksjö, , Sweden
Kalmar Hospital
Kalmar, , Sweden
Skåne University Hospital
Lund, , Sweden
Länssjukhuset Sundsvall
Sundsvall, , Sweden
Norra Älvsborgs Länssjukhus
Trollhättan, , Sweden
Norrlands University Hopsital
Umeå, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PD-aAPD-01-INT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.