- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02470598
PD-Improved Dialysis Efficiency With Adapted APD (PD-IDEA)
PD-Improved Dialysis Efficiency With Adapted APD - PD-IDEA
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brno, Czechia
- Faculty Hospital Brno-Bohunice
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Liberec, Czechia
- Hospital Liberec
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Mlada Boleslav, Czechia
- Regional Hospital in Mlada Boleslav
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Nove Mesto na Morave, Czechia
- Hospital Nové Město na Moravě
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Pilsen, Czechia
- Faculty Hospital Pilsen
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Prague, Czechia
- Faculty Hospital Karlovo namesti
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Prague, Czechia
- Faculty Hospital Strahov
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Prague, Czechia
- NC centre Vinohrady
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Sokolov, Czechia
- NC centre Sokolov
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Trebic, Czechia
- Hospital Třebíč
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Viborg, Denmark
- Regional Hospital Viborg
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Helsinki, Finland
- Helsinki University Hospital
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Kotka, Finland
- Kymenlaakso Central Hospital
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Lappeenranta, Finland
- Regional Hospital Roskilde
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Batu Caves, Malaysia
- Hospital Selayang
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Kuala Lumpur, Malaysia
- Gleneagles Hospital Kuala Lumpur (GHKL)
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Kuala Lumpur, Malaysia
- Hospital Universiti Kebangsaan Malaysia (HUKM)
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Serdang, Malaysia
- Hospital Serdang
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Seremban, Malaysia
- Hospital Seremban
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Albacete, Spain
- Complejo Hospitalario Universitario de Albacete
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Alcorcón, Spain
- Fundacion Hospital de Alcorcon
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Barcelona, Spain
- Hospital Clínic de Barcelona
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Barcelona, Spain
- Fundacion Puigvert
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Bilbao, Spain
- Hospital De Basurto
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Castellón De La Plana, Spain
- Hospital General de Castellon
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Girona, Spain
- Hospital Universitario di Girona Josep Trueta
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Granada, Spain
- Hospital General Virgen de las Nieves
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Jaén, Spain
- Complejo Hospitalario de Jaén
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Logroño, Spain
- Complejo Hospitalario San Millán-San Pedro De La Rioja
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Lugo, Spain
- Hospital Universitario Lucus Agusti
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Madrid, Spain
- Hospital Clinico San Carlos
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Madrid, Spain
- Hospital Universitario Ramon Y Cajal
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Majadahonda, Spain
- Hospital Universitario Puerta de Hierro
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Málaga, Spain
- Hospital Carlos Haya
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Ourense, Spain
- Complexo Hospitalario Universitario de Ourense (CHUO)
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Oviedo, Spain
- Hospital Universitario Central de Asturias (HUCA)
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San Sebastián, Spain
- Hospital Universitatio Donostia
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Santiago De Compostela, Spain
- Complejo Hospital Universitario de Santiago (CHUS)
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Valencia, Spain
- Hospital Clinico de Valencia
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Valencia, Spain
- Hospital Universitari i Politecnic La Fe
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Valencia, Spain
- Hospital Peset
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Vitoria, Spain
- Hospital Txagorritxu
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Ávila, Spain
- Complejo Asistencial de Ávila
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Danderyd, Sweden
- Danderyds sjukhus AB
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Eksjö, Sweden
- Höglandssjukhuset Eksjö/Nässjö
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Kalmar, Sweden
- Kalmar Hospital
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Lund, Sweden
- Skåne University Hospital
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Sundsvall, Sweden
- Länssjukhuset Sundsvall
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Trollhättan, Sweden
- Norra Älvsborgs Länssjukhus
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Umeå, Sweden
- Norrlands University Hopsital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hydration status
Time Frame: Every three months during one year
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Assessed via body composition measurements
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Every three months during one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Residual renal function
Time Frame: Every three months during one year
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Every three months during one year
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Changes in prescription
Time Frame: Every three months during one year
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Every three months during one year
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Achievement of adequate solute removal
Time Frame: Every three months during one year
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Every three months during one year
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Therapy tolerability
Time Frame: Every three months during one year
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Every three months during one year
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Other Outcome Measures
Outcome Measure |
Time Frame |
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Change of therapy modality
Time Frame: Every three months during one year
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Every three months during one year
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Collaborators and Investigators
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 record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PD-aAPD-01-INT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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