Clinical trial NCT01285726: Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)
Official title: Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Failure
Keywords: Peritoneal dialysis
Hydration status
Residual renal function
Bioimpedance spectroscopy
Body composition monitor
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 1092
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with chronic kidney disease (CKD) starting renal replacement therapy on APD or CAPD

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hydration status
timeFrame: Every three months over a period of four years
Secondary outcomes:
measure: Residual renal function
timeFrame: Every three months over a period of four years
measure: Peritoneal transport status
timeFrame: Every three months over a period of four years
measure: Time to change to haemodialysis
timeFrame: Four years
measure: Changes in PD prescription
timeFrame: Four years
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Klinikum Wels
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Geraardsbergen
country: Belgium
facility: ASZ Geraardsbergen
city: Leuven
country: Belgium
facility: U.Z. Leuven
city: Liège
country: Belgium
facility: CHU Sart Tilman
city: Roeselare
country: Belgium
facility: Heilig-Hart Roeselare
city: Mostar
country: Bosnia and Herzegovina
facility: KBC Mostar
city: Tuzla
country: Bosnia and Herzegovina
facility: UKC Tuzla
city: Belo Horizonte
country: Brazil
facility: Instituto Mineiro Nefrologia
city: Pirai
country: Brazil
facility: CDR Barra do Piraí
city: Sao Paolo
country: Brazil
facility: CETENE
city: Osijek
country: Croatia
facility: UHC Osijek
city: Split
country: Croatia
facility: UH Split
city: Zagreb
country: Croatia
facility: UH Merkur
city: La Habana
country: Cuba
facility: Instituto de Nefrología
city: Brno
country: Czech Republic
facility: University Hospital FN Brno Bohunice
city: Hradec Kralove
country: Czech Republic
facility: FN Hradec Kralove
city: Most
country: Czech Republic
facility: DS Most
city: Pilsen
country: Czech Republic
facility: Faculty Hospital Plzen
city: Prague
country: Czech Republic
facility: IKEM
city: Prague
country: Czech Republic
facility: VFN Strahov
city: Trebic
country: Czech Republic
facility: Třebíč Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Hillerød
country: Denmark
facility: Hillerød Hospital
city: Roskilde
country: Denmark
facility: Roskilde Hospital
city: Tallinn
country: Estonia
facility: North Estonian Regional Hospital
city: Tallinn
country: Estonia
facility: West Talinn Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Joensuu
country: Finland
facility: Central Hospital in Joensuu
city: Jyväskylä
country: Finland
facility: Keski-Suomen keskussairaala, Jyväskylä
city: Kotka
country: Finland
facility: Kymenlaakson keskussairaala, Kotka
city: Oys
country: Finland
facility: Oulu University Hospital
city: Pori
country: Finland
facility: Satakunnan keskussairaala, Pori
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Dunkerque
country: France
facility: C.H. Dunkerque
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Quimper
country: France
facility: AUB Quimper / Centre Hospitalier Laennec
city: Rezé
country: France
facility: ECHO Confluent
city: Strasbourg
country: France
facility: Hôpital Civil de Strasbourg
city: Bottrop
country: Germany
facility: KfH Nierenzentrum Bottrop
city: Braunschweig
country: Germany
facility: Klinikum Braunschweig
city: Heidelberg
country: Germany
facility: Nierenzentrum Heidelberg
city: Kiel
country: Germany
facility: Nieren und Hochdruckzentrum Kiel
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus
city: Velbert
country: Germany
facility: Nephrologisches Zentrum Velbert Innere Medizin und Nephrologie
city: Wiesbaden
country: Germany
facility: Nephrologische Praxis Wiesbaden
city: Alexandroupolis
country: Greece
facility: General University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: General Hospital of Athens G. Gennimatas
city: Ioannina
country: Greece
facility: General Hospital of Ioannina
city: Ioannina
country: Greece
facility: General University Hospital of Ioannina
city: Thessaloniki
country: Greece
facility: General University Hospital of Thessaloniki "AHEPA"
city: Chennai
country: India
facility: MMM - Chennai
city: Nahariyya
country: Israel
facility: Western Galilee Hospital
city: Bari
country: Italy
facility: UO Nefrologia Policlinico BARI
city: Cagliari
country: Italy
facility: Azienda Ospedaliera Brotzu
city: Palermo
country: Italy
facility: Ospedale Civico Palermo
city: Vicenza
country: Italy
facility: Ospedale San Bartolo
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Goyang
country: Korea, Republic of
facility: NHIC Ilsan Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospitall
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Riga
country: Latvia
facility: Med Alfa Ltda
city: Riga
country: Latvia
facility: P. Stradins hospital
city: Kaunas
country: Lithuania
facility: Kaunas clinics
city: Klaipeda
country: Lithuania
facility: Klaipeda Republic Hospital
city: Vilnius
country: Lithuania
facility: Vilnius Univ. Antakalnio Hospital
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
city: Aalesund
country: Norway
facility: Sykehuset i Møre og Romsdal HF
city: Bodø
country: Norway
facility: Nordlandssykehuset Bodø
city: Levanger
country: Norway
facility: Sykehuset Levanger
city: Sluppen
country: Norway
facility: St. Olavs Hospital
city: Carnaxide
country: Portugal
facility: Hospital Santa Cruz
city: Porto
country: Portugal
facility: CHP Hospital Santo Antonio
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruñ
city: Albacete
country: Spain
facility: CHU Albacete
city: Alcorcon
country: Spain
facility: Hosp. Univ. Fundacion Alcorcon
city: Almeria
country: Spain
facility: Hospital De Torrecardenas
city: Barcelona
country: Spain
facility: Fundació Puigvert
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Bilbao
country: Spain
facility: Hospital de Galdakano
city: Castellón
country: Spain
facility: Hospital General de Castellón
city: Cádiz
country: Spain
facility: Hospital Univ. Puerta del Mar
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: León
country: Spain
facility: CAULE
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: HGU Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Severo Ochoa
city: Madrid
country: Spain
facility: Hospital Univ. Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Puerta
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Manacor
country: Spain
facility: Fundación Hospital Manacor
city: Mollet del Valles
country: Spain
facility: Hospital de Mollet
city: Oviedo
country: Spain
facility: Hospital Universitario Central
city: Puerto Real
country: Spain
facility: Hospital Univ. de Puerto Real
city: Santander
country: Spain
facility: HUM Valdecilla
city: Santiago de Compostela
country: Spain
facility: CHUS
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
city: Vic
country: Spain
facility: Hospital general de Vic
city: Vigo
country: Spain
facility: CHU Xeral Cies Vigo
city: Vitoria
country: Spain
facility: Hospital Txagorritxu
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset Eskilstuna
city: Göteborg
country: Sweden
facility: Sahlgrenska PD-mottagningen
city: Halmstad
country: Sweden
facility: Hallands Hospital Halmstad
city: Luleå
country: Sweden
facility: Sunderby Sjukhus
city: Malmo
country: Sweden
facility: Skånes Universitetssjukhus Malmo
city: Stockholm
country: Sweden
facility: Danderyds Hospital
city: Stockholm
country: Sweden
facility: Karolinska Univers. Hospital
city: Stockholm
country: Sweden
facility: Kungsholmsdialysen
city: Luzern
country: Switzerland
facility: Luzern Kantonsspital
city: Antalya
country: Turkey
facility: Akdeniz Universitesi
city: Glasgow
country: United Kingdom
facility: Western Infirmary Glasgow
city: London
country: United Kingdom
facility: Royal London Hospital
city: Caracas
country: Venezuela
facility: FME Caracas
city: Charallave
country: Venezuela
facility: FME Charallave
city: Cumana
country: Venezuela
facility: Cenesuca (FME Cumana)
city: El Tigre
country: Venezuela
facility: FMC El tigre Edo Anzoátegui
city: Maracaibo
country: Venezuela
facility: FME Zulia
city: Maturin
country: Venezuela
facility: FME Maturin
city: Puerto La Cruz
country: Venezuela
facility: FME Puerto de la Cruz
city: Turmero
country: Venezuela
facility: FME Maracay
city: Valencia
country: Venezuela
facility: Instituto Docente de Urologia
city: Valencia
country: Venezuela
facility: Nefrologico Valencia sur
Study officials:
affiliation: Ospedale San Bartolo
name: Claudio Ronco, Prof
role: STUDY_CHAIR
affiliation: University Hospital, Ghent
name: Wim Van Biesen, Prof
role: STUDY_CHAIR
affiliation: French Language PD Registry (RDPLF)
name: Christian Verger, Dr
role: STUDY_CHAIR
References:
citation: Verger C, Ronco C, Van Biesen W, Heaf J, Vrtovsnik F, Vera Rivera M, Puide I, Azar R, Gauly A, Atiye S, De Los Rios T. Association of Prescription With Body Composition and Patient Outcomes in Incident Peritoneal Dialysis Patients. Front Med (Lausanne). 2021 Dec 24;8:737165. doi: 10.3389/fmed.2021.737165. eCollection 2021.
citation: Ronco C, Verger C, Crepaldi C, Pham J, De Los Rios T, Gauly A, Wabel P, Van Biesen W; IPOD-PD Study Group. Baseline hydration status in incident peritoneal dialysis patients: the initiative of patient outcomes in dialysis (IPOD-PD study)dagger. Nephrol Dial Transplant. 2015 May;30(5):849-58. doi: 10.1093/ndt/gfv013. Epub 2015 Mar 11.