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

NCT ID: NCT01285726

Last Updated: 2016-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1092 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Renal Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Non-interventional study

This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudio Ronco, Prof

Role: STUDY_CHAIR

Ospedale San Bartolo

Wim Van Biesen, Prof

Role: STUDY_CHAIR

University Hospital, Ghent

Christian Verger, Dr

Role: STUDY_CHAIR

French Language PD Registry (RDPLF)

Locations

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Tartu University Hospital

Tartu, , Estonia

Site Status

Helsinki University Hospital

Helsinki, , Finland

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Central Hospital in Joensuu

Joensuu, , Finland

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Keski-Suomen keskussairaala, Jyväskylä

Jyväskylä, , Finland

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Kymenlaakson keskussairaala, Kotka

Kotka, , Finland

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Oulu University Hospital

Oys, , Finland

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Satakunnan keskussairaala, Pori

Pori, , Finland

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Tampere University Hospital

Tampere, , Finland

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CHU de Bordeaux

Bordeaux, , France

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C.H. Dunkerque

Dunkirk, , France

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Hôpital Bichat - Claude Bernard

Paris, , France

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Centre Hospitalier René Dubos

Pontoise, , France

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AUB Quimper / Centre Hospitalier Laennec

Quimper, , France

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ECHO Confluent

Rezé, , France

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Hôpital Civil de Strasbourg

Strasbourg, , France

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KfH Nierenzentrum Bottrop

Bottrop, , Germany

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Klinikum Braunschweig

Braunschweig, , Germany

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Nierenzentrum Heidelberg

Heidelberg, , Germany

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Nieren und Hochdruckzentrum Kiel

Kiel, , Germany

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Robert Bosch Krankenhaus

Stuttgart, , Germany

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Azienda Ospedaliera Brotzu

Cagliari, , Italy

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Ospedale Civico Palermo

Palermo, , Italy

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Ospedale San Bartolo

Vicenza, , Italy

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Med Alfa Ltda

Riga, , Latvia

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P. Stradins hospital

Riga, , Latvia

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Kaunas clinics

Kaunas, , Lithuania

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Klaipeda Republic Hospital

Klaipėda, , Lithuania

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Vilnius Univ. Antakalnio Hospital

Vilnius, , Lithuania

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University Hospital Maastricht

Maastricht, , Netherlands

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Sykehuset i Møre og Romsdal HF

Ålesund, , Norway

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Nordlandssykehuset Bodø

Bodø, , Norway

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Sykehuset Levanger

Levanger, , Norway

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St. Olavs Hospital

Sluppen, , Norway

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Hospital Santa Cruz

Carnaxide, , Portugal

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CHP Hospital Santo Antonio

Porto, , Portugal

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Yeungnam University Hospital

Daegu, , South Korea

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NHIC Ilsan Hospital

Goyang, , South Korea

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Konkuk University Medical Center

Seoul, , South Korea

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Seoul National University Hospitall

Seoul, , South Korea

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Severance Hospital

Seoul, , South Korea

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Hospital Universitario A Coruñ

A Coruña, , Spain

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CHU Albacete

Albacete, , Spain

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Hosp. Univ. Fundacion Alcorcon

Alcorcón, , Spain

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Hospital De Torrecardenas

Almería, , Spain

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Fundació Puigvert

Barcelona, , Spain

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Hospital Clínic de Barcelona

Barcelona, , Spain

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Hospital de Basurto

Bilbao, , Spain

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Hospital de Galdakano

Bilbao, , Spain

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Hospital Univ. Puerta del Mar

Cadiz, , Spain

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Hospital General de Castellón

Castellon, , Spain

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Hospital Josep Trueta

Girona, , Spain

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Complejo Hospitalario de Jaén

Jaén, , Spain

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CAULE

León, , Spain

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Nephrologisches Zentrum Velbert Innere Medizin und Nephrologie

Velbert, , Germany

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Nephrologische Praxis Wiesbaden

Wiesbaden, , Germany

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General University Hospital of Alexandroupolis

Alexandroupoli, , Greece

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General Hospital of Athens G. Gennimatas

Athens, , Greece

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General Hospital of Ioannina

Ioannina, , Greece

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General University Hospital of Ioannina

Ioannina, , Greece

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General University Hospital of Thessaloniki "AHEPA"

Thessaloniki, , Greece

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MMM - Chennai

Chennai, , India

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Western Galilee Hospital

Nahariya, , Israel

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UO Nefrologia Policlinico BARI

Bari, , Italy

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Klinikum Wels

Wels, , Austria

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ASZ Aalst

Aalst, , Belgium

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ASZ Geraardsbergen

Geraardsbergen, , Belgium

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Ghent University Hospital

Ghent, , Belgium

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U.Z. Leuven

Leuven, , Belgium

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CHU Sart Tilman

Liège, , Belgium

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Heilig-Hart Roeselare

Roeselare, , Belgium

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KBC Mostar

Mostar, , Bosnia and Herzegovina

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UKC Tuzla

Tuzla, , Bosnia and Herzegovina

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Instituto Mineiro Nefrologia

Belo Horizonte, , Brazil

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CDR Barra do Piraí

Piraí, , Brazil

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CETENE

São Paulo, , Brazil

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UHC Osijek

Osijek, , Croatia

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UH Split

Split, , Croatia

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UH Merkur

Zagreb, , Croatia

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Instituto de Nefrología

La Habana, , Cuba

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University Hospital FN Brno Bohunice

Brno, , Czechia

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FN Hradec Kralove

Hradec Králové, , Czechia

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DS Most

Most, , Czechia

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Faculty Hospital Plzen

Pilsen, , Czechia

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IKEM

Prague, , Czechia

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VFN Strahov

Prague, , Czechia

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Třebíč Hospital

Třebíč, , Czechia

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Herlev Hospital

Herlev, , Denmark

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Hillerød Hospital

Hillerød, , Denmark

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Roskilde Hospital

Roskilde, , Denmark

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North Estonian Regional Hospital

Tallinn, , Estonia

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West Talinn Central Hospital

Tallinn, , Estonia

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Hospital San Pedro

Logroño, , Spain

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Hospital Lucus Augusti

Lugo, , Spain

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Fundación Jiménez Díaz

Madrid, , Spain

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HGU Gregorio Marañon

Madrid, , Spain

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Hospital Clinico San Carlos

Madrid, , Spain

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Hospital Severo Ochoa

Madrid, , Spain

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Hospital Univ. Ramón y Cajal

Madrid, , Spain

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Hospital Universitario Puerta

Madrid, , Spain

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Fundación Hospital Manacor

Manacor, , Spain

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Hospital Carlos Haya

Málaga, , Spain

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Hospital de Mollet

Mollet del Vallès, , Spain

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Hospital Universitario Central

Oviedo, , Spain

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Hospital Univ. de Puerto Real

Puerto Real, , Spain

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HUM Valdecilla

Santander, , Spain

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CHUS

Santiago de Compostela, , Spain

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Hospital Virgen de la Macarena

Seville, , Spain

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Hospital Clínico de Valencia

Valencia, , Spain

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Hospital Rio Hortega

Valladolid, , Spain

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Hospital general de Vic

Vic, , Spain

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CHU Xeral Cies Vigo

Vigo, , Spain

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Hospital Txagorritxu

Vitoria-Gasteiz, , Spain

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Mälarsjukhuset Eskilstuna

Eskilstuna, , Sweden

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Sahlgrenska PD-mottagningen

Gothenburg, , Sweden

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Hallands Hospital Halmstad

Halmstad, , Sweden

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Sunderby Sjukhus

Luleå, , Sweden

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Skånes Universitetssjukhus Malmo

Malmo, , Sweden

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Danderyds Hospital

Stockholm, , Sweden

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Karolinska Univers. Hospital

Stockholm, , Sweden

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Kungsholmsdialysen

Stockholm, , Sweden

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Luzern Kantonsspital

Lucerne, , Switzerland

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Akdeniz Universitesi

Antalya, , Turkey (Türkiye)

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Western Infirmary Glasgow

Glasgow, , United Kingdom

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Royal London Hospital

London, , United Kingdom

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FME Caracas

Caracas, , Venezuela

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FME Charallave

Charallave, , Venezuela

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Cenesuca (FME Cumana)

Cumaná, , Venezuela

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FMC El tigre Edo Anzoátegui

El Tigre, , Venezuela

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FME Zulia

Maracaibo, , Venezuela

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FME Maturin

Maturín, , Venezuela

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FME Puerto de la Cruz

Puerto Cruz, , Venezuela

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FME Maracay

Turmero, , Venezuela

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Instituto Docente de Urologia

Valencia, , Venezuela

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Nefrologico Valencia sur

Valencia, , Venezuela

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Countries

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Austria Belgium Bosnia and Herzegovina Brazil Croatia Cuba Czechia Denmark Estonia Finland France Germany Greece India Israel Italy Latvia Lithuania Netherlands Norway Portugal South Korea Spain Sweden Switzerland Turkey (Türkiye) United Kingdom Venezuela

References

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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.

Reference Type DERIVED
PMID: 35004718 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25762355 (View on PubMed)

Other Identifiers

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BCM-PD-02-INT

Identifier Type: -

Identifier Source: org_study_id

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