Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study) (IPOD-PD)

April 29, 2016 updated by: Fresenius Medical Care Deutschland GmbH

Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)

The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD) patients and its evolution over a period of four years, independent of the PD treatment modality (APD or CAPD) and the PD solution type.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Achieving optimal fluid balance remains a major clinical challenge in peritoneal dialysis (PD) patients. With the recent development of a new bioimpedance spectroscopy (BIS) device, the BCM-Body Composition Monitor (BCM), it is now possible to quantify deviations of hydration status and to define target weight directly.

It has been observed that more than 50% of the PD patients are overhydrated, as compared to the healthy population. This overhydration seems to be associated with modifiable practice-related factors, such as correct PD prescription according to membrane transport status, and dietary fluid intake.

The aim of this study is to assess the hydration status of incident PD patients, and diagnose the underlying reasons for incorrect fluid status. In addition, changes in fluid status, residual renal function and nutritional status, over a follow-up period of up to four years will be registered.

The investigators assume that the use of the BCM-Body Composition Monitor (BCM) provides quantitative measurement of hydration status and thereby supports physicians in identifying patients who are not euvolaemic. Hence, the BCM allows an improved management of underlying causes of non-euvolaemic hydration state and appropriate monitoring of fluid status.

Study Type

Observational

Enrollment (Actual)

1092

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

  • Austria
      • Wels, Austria
        • Klinikum Wels
  • Belgium
      • Aalst, Belgium
        • ASZ Aalst
      • Gent, Belgium
        • Ghent University Hospital
      • Geraardsbergen, Belgium
        • ASZ Geraardsbergen
      • Leuven, Belgium
        • U.Z. Leuven
      • Liège, Belgium
        • Chu Sart Tilman
      • Roeselare, Belgium
        • Heilig-Hart Roeselare
  • Bosnia and Herzegovina
      • Mostar, Bosnia and Herzegovina
        • KBC Mostar
      • Tuzla, Bosnia and Herzegovina
        • UKC Tuzla
  • Brazil
      • Belo Horizonte, Brazil
        • Instituto Mineiro Nefrologia
      • Pirai, Brazil
        • CDR Barra do Piraí
      • Sao Paolo, Brazil
        • CETENE
  • Croatia
      • Osijek, Croatia
        • UHC Osijek
      • Split, Croatia
        • UH Split
      • Zagreb, Croatia
        • UH Merkur
  • Cuba
      • La Habana, Cuba
        • Instituto de Nefrología
  • Czech Republic
      • Brno, Czech Republic
        • University Hospital FN Brno Bohunice
      • Hradec Kralove, Czech Republic
        • FN Hradec Králové
      • Most, Czech Republic
        • DS Most
      • Pilsen, Czech Republic
        • Faculty Hospital Plzen
      • Prague, Czech Republic
        • IKEM
      • Prague, Czech Republic
        • VFN Strahov
      • Trebic, Czech Republic
        • Třebíč Hospital
  • Denmark
      • Herlev, Denmark
        • Herlev Hospital
      • Hillerød, Denmark
        • Hillerød Hospital
      • Roskilde, Denmark
        • Roskilde Hospital
  • Estonia
      • Tallinn, Estonia
        • North Estonian Regional Hospital
      • Tallinn, Estonia
        • West Talinn Central Hospital
      • Tartu, Estonia
        • Tartu University Hospital
  • Finland
      • Helsinki, Finland
        • Helsinki university hospital
      • Joensuu, Finland
        • Central Hospital in Joensuu
      • Jyväskylä, Finland
        • Keski-Suomen keskussairaala, Jyväskylä
      • Kotka, Finland
        • Kymenlaakson keskussairaala, Kotka
      • Oys, Finland
        • Oulu University Hospital
      • Pori, Finland
        • Satakunnan keskussairaala, Pori
      • Tampere, Finland
        • Tampere University Hospital
  • France
      • Bordeaux, France
        • CHU de Bordeaux
      • Dunkerque, France
        • C.H. Dunkerque
      • Paris, France
        • Hôpital Bichat - Claude Bernard
      • Pontoise, France
        • Centre Hospitalier René Dubos
      • Quimper, France
        • AUB Quimper / Centre Hospitalier Laennec
      • Rezé, France
        • ECHO Confluent
      • Strasbourg, France
        • Hôpital Civil de Strasbourg
  • Germany
      • Bottrop, Germany
        • KfH Nierenzentrum Bottrop
      • Braunschweig, Germany
        • Klinikum Braunschweig
      • Heidelberg, Germany
        • Nierenzentrum Heidelberg
      • Kiel, Germany
        • Nieren und Hochdruckzentrum Kiel
      • Stuttgart, Germany
        • Robert Bosch Krankenhaus
      • Velbert, Germany
        • Nephrologisches Zentrum Velbert Innere Medizin und Nephrologie
      • Wiesbaden, Germany
        • Nephrologische Praxis Wiesbaden
  • Greece
      • Alexandroupolis, Greece
        • General University Hospital of Alexandroupolis
      • Athens, Greece
        • General Hospital of Athens G. Gennimatas
      • Ioannina, Greece
        • General Hospital of Ioannina
      • Ioannina, Greece
        • General University Hospital of Ioannina
      • Thessaloniki, Greece
        • General University Hospital of Thessaloniki "AHEPA"
  • India
      • Chennai, India
        • MMM - Chennai
  • Israel
      • Nahariyya, Israel
        • Western Galilee Hospital
  • Italy
      • Bari, Italy
        • UO Nefrologia Policlinico BARI
      • Cagliari, Italy
        • Azienda Ospedaliera Brotzu
      • Palermo, Italy
        • Ospedale Civico Palermo
      • Vicenza, Italy
        • Ospedale San Bartolo
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Yeungnam University Hospital
      • Goyang, Korea, Republic of
        • NHIC Ilsan Hospital
      • Seoul, Korea, Republic of
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospitall
  • Latvia
      • Riga, Latvia
        • Med Alfa Ltda
      • Riga, Latvia
        • P. Stradins hospital
  • Lithuania
      • Kaunas, Lithuania
        • Kaunas clinics
      • Klaipeda, Lithuania
        • Klaipeda Republic Hospital
      • Vilnius, Lithuania
        • Vilnius Univ. Antakalnio Hospital
  • Netherlands
      • Maastricht, Netherlands
        • University Hospital Maastricht
  • Norway
      • Aalesund, Norway
        • Sykehuset i Møre og Romsdal HF
      • Bodø, Norway
        • Nordlandssykehuset Bodø
      • Levanger, Norway
        • Sykehuset Levanger
      • Sluppen, Norway
        • St. Olavs hospital
  • Portugal
      • Carnaxide, Portugal
        • Hospital Santa Cruz
      • Porto, Portugal
        • CHP Hospital Santo Antonio
  • Spain
      • A Coruña, Spain
        • Hospital Universitario A Coruñ
      • Albacete, Spain
        • CHU Albacete
      • Alcorcon, Spain
        • Hosp. Univ. Fundacion Alcorcon
      • Almeria, Spain
        • Hospital de Torrecardenas
      • Barcelona, Spain
        • Hospital Clínic de Barcelona
      • Barcelona, Spain
        • Fundacio Puigvert
      • Bilbao, Spain
        • Hospital de Basurto
      • Bilbao, Spain
        • Hospital de Galdakano
      • Castellón, Spain
        • Hospital General de Castellón
      • Cádiz, Spain
        • Hospital Univ. Puerta del Mar
      • Girona, Spain
        • Hospital Josep Trueta
      • Jaén, Spain
        • Complejo Hospitalario de Jaen
      • León, Spain
        • CAULE
      • Logroño, Spain
        • Hospital San Pedro
      • Lugo, Spain
        • Hospital Lucus Augusti
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • HGU Gregorio Marañon
      • Madrid, Spain
        • Hospital Severo Ochoa
      • Madrid, Spain
        • Hospital Univ. Ramón y Cajal
      • Madrid, Spain
        • Hospital Universitario Puerta
      • Malaga, Spain
        • Hospital Carlos Haya
      • Manacor, Spain
        • Fundación Hospital Manacor
      • Mollet del Valles, Spain
        • Hospital de Mollet
      • Oviedo, Spain
        • Hospital Universitario Central
      • Puerto Real, Spain
        • Hospital Univ. de Puerto Real
      • Santander, Spain
        • HUM Valdecilla
      • Santiago de Compostela, Spain
        • CHUS
      • Sevilla, Spain
        • Hospital Virgen de la Macarena
      • Valencia, Spain
        • Hospital Clinico de Valencia
      • Valladolid, Spain
        • Hospital Rio Hortega
      • Vic, Spain
        • Hospital General de Vic
      • Vigo, Spain
        • CHU Xeral Cies Vigo
      • Vitoria, Spain
        • Hospital Txagorritxu
  • Sweden
      • Eskilstuna, Sweden
        • Mälarsjukhuset Eskilstuna
      • Göteborg, Sweden
        • Sahlgrenska PD-mottagningen
      • Halmstad, Sweden
        • Hallands Hospital Halmstad
      • Luleå, Sweden
        • Sunderby Sjukhus
      • Malmo, Sweden
        • Skånes Universitetssjukhus Malmö
      • Stockholm, Sweden
        • Danderyds Hospital
      • Stockholm, Sweden
        • Karolinska Univers. Hospital
      • Stockholm, Sweden
        • Kungsholmsdialysen
  • Switzerland
      • Luzern, Switzerland
        • Luzern Kantonsspital
  • Turkey
      • Antalya, Turkey
        • Akdeniz Universitesi
  • United Kingdom
      • Glasgow, United Kingdom
        • Western Infirmary Glasgow
      • London, United Kingdom
        • Royal London Hospital
  • Venezuela
      • Caracas, Venezuela
        • FME Caracas
      • Charallave, Venezuela
        • FME Charallave
      • Cumana, Venezuela
        • Cenesuca (FME Cumana)
      • El Tigre, Venezuela
        • FMC El tigre Edo Anzoátegui
      • Maracaibo, Venezuela
        • FME Zulia
      • Maturin, Venezuela
        • FME Maturin
      • Puerto La Cruz, Venezuela
        • FME Puerto de la Cruz
      • Turmero, Venezuela
        • FME Maracay
      • Valencia, Venezuela
        • Instituto Docente de Urologia
      • Valencia, Venezuela
        • Nefrologico Valencia sur

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

Adult patients with chronic kidney disease (CKD) starting renal replacement therapy on APD or CAPD

Description

Inclusion Criteria:

  • Incident patients directly before start of peritoneal dialysis
  • Patients in whom routine measurement of body composition monitoring is performed

Exclusion Criteria:

  • Patients treated with HD before start of PD
  • Patients in whom body composition monitoring cannot be performed

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 over a period of four years
Assessed via body composition measurements (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW)) (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW))
Every three months over a period of four years

Secondary Outcome Measures

Outcome Measure
Time Frame
Residual renal function
Time Frame: Every three months over a period of four years
Every three months over a period of four years
Peritoneal transport status
Time Frame: Every three months over a period of four years
Every three months over a period of four years
Time to change to haemodialysis
Time Frame: Four years
Four years
Changes in PD prescription
Time Frame: Four years
Four years

Collaborators and Investigators

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

Sponsor

Fresenius Medical Care Deutschland GmbH

Investigators

  • Study Chair: Claudio Ronco, Prof, Ospedale San Bartolo
  • Study Chair: Wim Van Biesen, Prof, University Hospital, Ghent
  • Study Chair: Christian Verger, Dr, French Language PD Registry (RDPLF)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 27, 2011

First Posted (Estimate)

January 28, 2011

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCM-PD-02-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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