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

Chronic Renal Failure Clinical Trial

— IPOD-PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285726
• Other study ID #: BCM-PD-02-INT
• Status: Completed
• Phase: N/A
• First received: January 26, 2011
• Last updated: April 29, 2016
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBosnia: Federal Ministry of HealthCroatia: Ethics CommitteeFinland: Ethics CommitteeEstonia: Research Ethics CommitteeGermany: Ethics CommissionGreece: Ethics CommitteeItaly: Ethics CommitteeLatvia: Institutional Review BoardLithuania: Bioethics CommitteeNetherlands: Independent Ethics CommitteeNorway: Ethics CommitteePortugal: Health Ethic CommitteeSpain: Comité Ético de Investigación ClínicaSweden: Institutional Review BoardSwitzerland: EthikkommissionTurkey: Ethics CommitteeBrazil: Ethics CommitteeCuba: Scientific and Ethics CommitteeVenezuela: Ethics CommitteeKorea: Institutional Review BoardIndia: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1092
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic

Intervention

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

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Countries where clinical trial is conducted

Austria,  Belgium,  Bosnia and Herzegovina,  Brazil,  Croatia,  Cuba,  Czech Republic,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Netherlands,  Norway,  Portugal,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydration status	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	No
Secondary	Residual renal function		Every three months over a period of four years	No
Secondary	Peritoneal transport status		Every three months over a period of four years	No
Secondary	Time to change to haemodialysis		Four years	No
Secondary	Changes in PD prescription		Four years	No