Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)
- Conditions
- Chronic Renal Failure
- Registration Number
- NCT01285726
- Lead Sponsor
- Fresenius Medical Care Deutschland GmbH
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1092
- Incident patients directly before start of peritoneal dialysis
- Patients in whom routine measurement of body composition monitoring is performed
- Patients treated with HD before start of PD
- Patients in whom body composition monitoring cannot be performed
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hydration status 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))
- Secondary Outcome Measures
Name Time Method Changes in PD prescription Four years Residual renal function Every three months over a period of four years Peritoneal transport status Every three months over a period of four years Time to change to haemodialysis Four years
Trial Locations
- Locations (134)
Třebíč Hospital
🇨🇿Trebic, Czech Republic
North Estonian Regional Hospital
🇪🇪Tallinn, Estonia
University Hospital FN Brno Bohunice
🇨🇿Brno, Czech Republic
FN Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
VFN Strahov
🇨🇿Prague, Czech Republic
Tartu University Hospital
🇪🇪Tartu, Estonia
Keski-Suomen keskussairaala, Jyväskylä
🇫🇮Jyväskylä, Finland
Nordlandssykehuset Bodø
🇳🇴Bodø, Norway
Sykehuset Levanger
🇳🇴Levanger, Norway
CHP Hospital Santo Antonio
🇵🇹Porto, Portugal
Cenesuca (FME Cumana)
🇻🇪Cumana, Venezuela
FME Zulia
🇻🇪Maracaibo, Venezuela
Luzern Kantonsspital
🇨🇭Luzern, Switzerland
FMC El tigre Edo Anzoátegui
🇻🇪El Tigre, Venezuela
FME Puerto de la Cruz
🇻🇪Puerto La Cruz, Venezuela
UH Merkur
🇭🇷Zagreb, Croatia
ASZ Aalst
🇧🇪Aalst, Belgium
CDR Barra do Piraí
🇧🇷Pirai, Brazil
KBC Mostar
🇧🇦Mostar, Bosnia and Herzegovina
Klinikum Wels
🇦🇹Wels, Austria
CHU Sart Tilman
🇧🇪Liège, Belgium
Instituto Mineiro Nefrologia
🇧🇷Belo Horizonte, Brazil
CHU de Bordeaux
🇫🇷Bordeaux, France
Instituto de Nefrología
🇨🇺La Habana, Cuba
Kymenlaakson keskussairaala, Kotka
🇫🇮Kotka, Finland
Heilig-Hart Roeselare
🇧🇪Roeselare, Belgium
Hôpital Civil de Strasbourg
🇫🇷Strasbourg, France
CHU Albacete
🇪🇸Albacete, Spain
General University Hospital of Ioannina
🇬🇷Ioannina, Greece
UHC Osijek
🇭🇷Osijek, Croatia
Ospedale San Bartolo
🇮🇹Vicenza, Italy
NHIC Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Nierenzentrum Heidelberg
🇩🇪Heidelberg, Germany
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
KfH Nierenzentrum Bottrop
🇩🇪Bottrop, Germany
Fundació Puigvert
🇪🇸Barcelona, Spain
UKC Tuzla
🇧🇦Tuzla, Bosnia and Herzegovina
UH Split
🇭🇷Split, Croatia
Faculty Hospital Plzen
🇨🇿Pilsen, Czech Republic
General Hospital of Ioannina
🇬🇷Ioannina, Greece
UO Nefrologia Policlinico BARI
🇮🇹Bari, Italy
Azienda Ospedaliera Brotzu
🇮🇹Cagliari, Italy
C.H. Dunkerque
🇫🇷Dunkerque, France
ECHO Confluent
🇫🇷Rezé, France
Hospital Carlos Haya
🇪🇸Malaga, Spain
CETENE
🇧🇷Sao Paolo, Brazil
Nephrologische Praxis Wiesbaden
🇩🇪Wiesbaden, Germany
Western Galilee Hospital
🇮🇱Nahariyya, Israel
IKEM
🇨🇿Prague, Czech Republic
Hôpital Bichat - Claude Bernard
🇫🇷Paris, France
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
General University Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Greece
General University Hospital of Thessaloniki "AHEPA"
🇬🇷Thessaloniki, Greece
Skånes Universitetssjukhus Malmo
🇸🇪Malmo, Sweden
Karolinska Univers. Hospital
🇸🇪Stockholm, Sweden
AUB Quimper / Centre Hospitalier Laennec
🇫🇷Quimper, France
Hospital Universitario A Coruñ
🇪🇸A Coruña, Spain
Hospital De Torrecardenas
🇪🇸Almeria, Spain
Hospital General de Castellón
🇪🇸Castellón, Spain
MMM - Chennai
🇮🇳Chennai, India
General Hospital of Athens G. Gennimatas
🇬🇷Athens, Greece
Ospedale Civico Palermo
🇮🇹Palermo, Italy
Akdeniz Universitesi
🇹🇷Antalya, Turkey
Hospital Univ. de Puerto Real
🇪🇸Puerto Real, Spain
Hospital Josep Trueta
🇪🇸Girona, Spain
HGU Gregorio Marañon
🇪🇸Madrid, Spain
Centre Hospitalier René Dubos
🇫🇷Pontoise, France
Hospital de Mollet
🇪🇸Mollet del Valles, Spain
Nieren und Hochdruckzentrum Kiel
🇩🇪Kiel, Germany
Hospital Txagorritxu
🇪🇸Vitoria, Spain
Fundación Hospital Manacor
🇪🇸Manacor, Spain
Hospital Santa Cruz
🇵🇹Carnaxide, Portugal
University Hospital Maastricht
🇳🇱Maastricht, Netherlands
Mälarsjukhuset Eskilstuna
🇸🇪Eskilstuna, Sweden
Sunderby Sjukhus
🇸🇪Luleå, Sweden
Hospital Univ. Puerta del Mar
🇪🇸Cádiz, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Univ. Ramón y Cajal
🇪🇸Madrid, Spain
CAULE
🇪🇸León, Spain
Western Infirmary Glasgow
🇬🇧Glasgow, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
FME Maturin
🇻🇪Maturin, Venezuela
Hospital Universitario Puerta
🇪🇸Madrid, Spain
Hosp. Univ. Fundacion Alcorcon
🇪🇸Alcorcon, Spain
Hospital de Galdakano
🇪🇸Bilbao, Spain
Hospital Lucus Augusti
🇪🇸Lugo, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
FME Charallave
🇻🇪Charallave, Venezuela
Sahlgrenska PD-mottagningen
🇸🇪Göteborg, Sweden
Hallands Hospital Halmstad
🇸🇪Halmstad, Sweden
Hospital general de Vic
🇪🇸Vic, Spain
Herlev Hospital
🇩🇰Herlev, Denmark
Hospital Universitario Central
🇪🇸Oviedo, Spain
Hospital Virgen de la Macarena
🇪🇸Sevilla, Spain
Hospital Severo Ochoa
🇪🇸Madrid, Spain
Hospital Rio Hortega
🇪🇸Valladolid, Spain
CHU Xeral Cies Vigo
🇪🇸Vigo, Spain
Ghent University Hospital
🇧🇪Gent, Belgium
Hillerød Hospital
🇩🇰Hillerød, Denmark
Roskilde Hospital
🇩🇰Roskilde, Denmark
Klinikum Braunschweig
🇩🇪Braunschweig, Germany
Robert Bosch Krankenhaus
🇩🇪Stuttgart, Germany
Nephrologisches Zentrum Velbert Innere Medizin und Nephrologie
🇩🇪Velbert, Germany
P. Stradins hospital
🇱🇻Riga, Latvia
Seoul National University Hospitall
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Med Alfa Ltda
🇱🇻Riga, Latvia
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Kaunas clinics
🇱🇹Kaunas, Lithuania
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
CHUS
🇪🇸Santiago de Compostela, Spain
HUM Valdecilla
🇪🇸Santander, Spain
Danderyds Hospital
🇸🇪Stockholm, Sweden
Kungsholmsdialysen
🇸🇪Stockholm, Sweden
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital San Pedro
🇪🇸Logroño, Spain
St. Olavs Hospital
🇳🇴Sluppen, Norway
Oulu University Hospital
🇫🇮Oys, Finland
Satakunnan keskussairaala, Pori
🇫🇮Pori, Finland
Klaipeda Republic Hospital
🇱🇹Klaipeda, Lithuania
Sykehuset i Møre og Romsdal HF
🇳🇴Aalesund, Norway
Helsinki University Hospital
🇫🇮Helsinki, Finland
FME Caracas
🇻🇪Caracas, Venezuela
FME Maracay
🇻🇪Turmero, Venezuela
DS Most
🇨🇿Most, Czech Republic
West Talinn Central Hospital
🇪🇪Tallinn, Estonia
Central Hospital in Joensuu
🇫🇮Joensuu, Finland
Vilnius Univ. Antakalnio Hospital
🇱🇹Vilnius, Lithuania
Nefrologico Valencia sur
🇻🇪Valencia, Venezuela
Tampere University Hospital
🇫🇮Tampere, Finland
Instituto Docente de Urologia
🇻🇪Valencia, Venezuela
U.Z. Leuven
🇧🇪Leuven, Belgium
ASZ Geraardsbergen
🇧🇪Geraardsbergen, Belgium