PD-Improved Dialysis Efficiency With Adapted APD (PD-IDEA)

August 5, 2020 updated by: Fresenius Medical Care Deutschland GmbH

PD-Improved Dialysis Efficiency With Adapted APD - PD-IDEA

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
        • Faculty Hospital Brno-Bohunice
      • Liberec, Czechia
        • Hospital Liberec
      • Mlada Boleslav, Czechia
        • Regional Hospital in Mlada Boleslav
      • Nove Mesto na Morave, Czechia
        • Hospital Nové Město na Moravě
      • Pilsen, Czechia
        • Faculty Hospital Pilsen
      • Prague, Czechia
        • Faculty Hospital Karlovo namesti
      • Prague, Czechia
        • Faculty Hospital Strahov
      • Prague, Czechia
        • NC centre Vinohrady
      • Sokolov, Czechia
        • NC centre Sokolov
      • Trebic, Czechia
        • Hospital Třebíč
  • Denmark
      • Viborg, Denmark
        • Regional Hospital Viborg
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Kotka, Finland
        • Kymenlaakso Central Hospital
      • Lappeenranta, Finland
        • Regional Hospital Roskilde
  • Malaysia
      • Batu Caves, Malaysia
        • Hospital Selayang
      • Kuala Lumpur, Malaysia
        • Gleneagles Hospital Kuala Lumpur (GHKL)
      • Kuala Lumpur, Malaysia
        • Hospital Universiti Kebangsaan Malaysia (HUKM)
      • Serdang, Malaysia
        • Hospital Serdang
      • Seremban, Malaysia
        • Hospital Seremban
  • Spain
      • Albacete, Spain
        • Complejo Hospitalario Universitario de Albacete
      • Alcorcón, Spain
        • Fundacion Hospital de Alcorcon
      • Barcelona, Spain
        • Hospital Clinic De Barcelona
      • Barcelona, Spain
        • Fundaciòn Puigvert
      • Bilbao, Spain
        • Hospital de Basurto
      • Castellón De La Plana, Spain
        • Hospital General de Castellón
      • Girona, Spain
        • Hospital Universitario di Girona Josep Trueta
      • Granada, Spain
        • Hospital General Virgen de las Nieves
      • Jaén, Spain
        • Complejo Hospitalario de Jaén
      • Logroño, Spain
        • Complejo Hospitalario San Millán-San Pedro De La Rioja
      • Lugo, Spain
        • Hospital Universitario Lucus Agustí
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Majadahonda, Spain
        • Hospital Universitario Puerta de Hierro
      • Málaga, Spain
        • Hospital Carlos Haya
      • Ourense, Spain
        • Complexo Hospitalario Universitario de Ourense (CHUO)
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias (HUCA)
      • San Sebastián, Spain
        • Hospital Universitatio Donostia
      • Santiago De Compostela, Spain
        • Complejo Hospital Universitario de Santiago (CHUS)
      • Valencia, Spain
        • Hospital Clinico de Valencia
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain
        • Hospital Peset
      • Vitoria, Spain
        • Hospital Txagorritxu
      • Ávila, Spain
        • Complejo Asistencial de Ávila
  • Sweden
      • Danderyd, Sweden
        • Danderyds Sjukhus AB
      • Eksjö, Sweden
        • Höglandssjukhuset Eksjö/Nässjö
      • Kalmar, Sweden
        • Kalmar Hospital
      • Lund, Sweden
        • Skåne University Hospital
      • Sundsvall, Sweden
        • Länssjukhuset Sundsvall
      • Trollhättan, Sweden
        • Norra Älvsborgs Länssjukhus
      • Umeå, Sweden
        • Norrlands University Hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic kidney disease (CKD) being treated or starting renal replacement therapy with aAPD

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Assessed via body composition measurements
Every three months during one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Residual renal function
Time Frame: Every three months during one year
Every three months during one year
Changes in prescription
Time Frame: Every three months during one year
Every three months during one year
Achievement of adequate solute removal
Time Frame: Every three months during one year
Every three months during one year
Therapy tolerability
Time Frame: Every three months during one year
Every three months during one year

Other Outcome Measures

Outcome Measure
Time Frame
Change of therapy modality
Time Frame: Every three months during one year
Every three months during one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

July 1, 2020

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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