PD-Improved Dialysis Efficiency With Adapted APD

Chronic Renal Failure Clinical Trial

— PD-IDEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470598
• Other study ID #: PD-aAPD-01-INT
• Status: Completed
• Start date: March 2015
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic

Intervention

Other:
• 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

Locations

Country	Name	City	State
Czechia	Faculty Hospital Brno-Bohunice	Brno
Czechia	Hospital Liberec	Liberec
Czechia	Regional Hospital in Mlada Boleslav	Mlada Boleslav
Czechia	Hospital Nove Mesto na Morave	Nove Mesto na Morave
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	Trebic
Denmark	Regional Hospital Viborg	Viborg
Finland	Helsinki University Hospital	Helsinki
Finland	Kymenlaakso Central Hospital	Kotka
Finland	Regional Hospital Roskilde	Lappeenranta
Malaysia	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
Spain	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	Castellón De La Plana
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
Sweden	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

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Countries where clinical trial is conducted

Czechia,  Denmark,  Finland,  Malaysia,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of therapy modality		Every three months during one year
Primary	Hydration status	Assessed via body composition measurements	Every three months during one year
Secondary	Residual renal function		Every three months during one year
Secondary	Changes in prescription		Every three months during one year
Secondary	Achievement of adequate solute removal		Every three months during one year
Secondary	Therapy tolerability		Every three months during one year