Conventional Hemodialysis Vs Short Daily Hemodialysis for Patients Coming From Peritoneal Dialysis (HAPD/CAPD)
NCT ID: NCT02002949
Last Updated: 2016-03-09
Study Results
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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UNKNOWN
NA
144 participants
INTERVENTIONAL
2014-02-28
2017-12-31
Brief Summary
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The adequacy of this alternative dialysis technique confirms that the SDHD at home is a viable option for patients coming from HAPD/CAPD and indeed support the clinical benefits of home SDHD compared with those of conventional dialysis: lowering blood pressure and lower use of antihypertensive drugs , improving the quality of life, maintenance of residual renal function related to a reduced risk of death and reduction in operating costs of dialysis and patient transport.
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Detailed Description
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Home hemodialysis could be an integrated therapeutic option favoring the de-hospitalization of patients requiring hemodialysis. Aim of this study is to offer the patient a better quality of life, to create the conditions for an improvement in blood pressure, phosphate control, of cardiovascular morbidity and mortality, and to reduce costs for the National Health Service.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Short daily hemodialsysis
Short Daily Hemodialysis (SDHD) - 5 or 6 treatments per week for approximately 3 hours (range 2 to 4 hours) per treatment, to be performed at the patient's home, using any hemodialysis machine as chosen by the responsible clinician in each participating center
Short daily hemodialysis
5 or 6 treatments per week for approximately 3 hours (range 2 to 4 hours) per treatment, to be performed at the patient's home, using any hemodialysis machine as chosen by the responsible clinician in each participating center
Conventional hemodialysis
Conventional Hemodialysis (CHD) - 3 treatments per week for approximately 4 hours (range 3 hours and 30 minutes to 4 hours) per treatment, to be performed in a dialysis clinic using any hemodialysis machine as chosen by the responsible clinicians in each participating center
Conventional hemodialysis
3 treatments per week for approximately 4 hours (range 3 hours and 30 minutes to 4 hours) per treatment, to be performed in a dialysis clinic using any hemodialysis machine as chosen by the responsible clinicians in each participating center
Interventions
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Short daily hemodialysis
5 or 6 treatments per week for approximately 3 hours (range 2 to 4 hours) per treatment, to be performed at the patient's home, using any hemodialysis machine as chosen by the responsible clinician in each participating center
Conventional hemodialysis
3 treatments per week for approximately 4 hours (range 3 hours and 30 minutes to 4 hours) per treatment, to be performed in a dialysis clinic using any hemodialysis machine as chosen by the responsible clinicians in each participating center
Eligibility Criteria
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Inclusion Criteria
2. Currently performing Peritoneal Dialysis (HAPD and CAPD) for a minimum of 3 months.
3. Age 18 years or older.
4. Suitability for SDHD, determined on the basis of the following conditions:
* willingness to be trained and perform frequent hemodialysis at home;
* physically and mentally capable of performing frequent hemodialysis at home;
* evaluation of the subject's home environment by a physician, training nurse and /or social worker;
* a home dialysis partner willing to assist the participant in performing treatments at home;
* agreement by a multidisciplinary (physician, nurse and any other professionals) team that the subject is suitable for SDHD.
5. Expected survival of at least one year.
6. Ability to understand and willingness to sign an informed consent statement.
Exclusion Criteria
2. Being scheduled for change of modality or plans to relocate to an area outside of the clinical center.
3. Cancer
4. Pregnancy-lactation.
18 Years
ALL
No
Sponsors
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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
OTHER
Responsible Party
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Loreto GESUALDO
FULL PROFESSOR
Principal Investigators
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Loreto LG GESUALDO, MD
Role: PRINCIPAL_INVESTIGATOR
AOUConsorziale, Bari, Italy
Locations
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Ospedale Santa Chiara
Trento, , Italy
AUO Policlinico Consorziale
Bari, BA, Italy
Ospedale Santa Marta e Santa Venera di Acireale
Acireale, , Italy
A.O.U. Ospedali Riuniti di Ancona
Ancona, , Italy
Presidio Ospedaliero 1 - Arezzo, "San Donato"
Arezzo, , Italy
Policlinico Universitario S. Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliera G. Brotzu
Cagliari, , Italy
Ospedale S. Giacomo Apostolo
Castelfranco Veneto, , Italy
Ospedale per l'emergenza Cannizzaro Catania
Catania, , Italy
Ospedale SS.Annunziata
Chieti, , Italy
Ospedale Civile di Cremona
Cremona, , Italy
Azienda Ospedaliero Universitaria "OO.RR." di Foggia
Foggia, , Italy
ASL 12 Di Viareggio - Ospedale Versilia
Lido di Camaiore, , Italy
Seconda Università degli Studi di Napoli
Napoli, , Italy
Secondo Policlinico-Azienda Ospedaliera Universitaria "Federico II"
Napoli, , Italy
Secondo Ospedale S. Francesco, ASL 3 S
Nuoro, , Italy
Ospedale Civile Spirito Santo
Pescara, , Italy
Ospedale Civile di Piacenza
Piacenza, , Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Ospedale G. B. Grassi
Roma, , Italy
Università Cattolica Del Sacro Cuore
Roma, , Italy
Ospedale Santa Maria della Misericordia
Rovigo, , Italy
Ospedale D. Anna
San Fermo della Battaglia, , Italy
Ospedale Civile San Giovanni Di Dio
San Michele, , Italy
Ospedale Principe di Piemonte
Senigallia, , Italy
Ospedale Umberto I di Siracusa
Syracuse, , Italy
Ospedale Mazzini
Teramo, , Italy
Ospedale San giovanni Battista Molinette
Torino, , Italy
Ospedale San giovanni Bosco
Torino, , Italy
Ospedale Treviglio - Caravaggio
Treviglio, , Italy
Ospedale Civile di Voghera
Voghera, , Italy
Countries
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Central Contacts
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Facility Contacts
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Giovanni Giorgio Battaglia
Role: primary
Giovanni Frascà
Role: primary
Ennio Duranti
Role: primary
Gaetano La Manna
Role: primary
Antonello Pani
Role: primary
Cataldo Abaterusso
Role: primary
Massimo Matalone
Role: primary
Mario Bonomini
Role: primary
Fabio Malberti
Role: primary
Giuseppe Grandaliano
Role: primary
Vincenzo Panichi
Role: primary
Giovambattista Capasso
Role: primary
Stefano Federico
Role: primary
Maria Maddalena Sedda
Role: primary
Mario Campanella
Role: primary
Roberto Scarpioni
Role: primary
Francesca Egidi
Role: primary
Massimo Morosetti
Role: primary
Giovanni Gambaro
Role: primary
Fulvio Fiorini
Role: primary
Claudio Minoretti
Role: primary
Antonio Granata
Role: primary
Rolando Boggi
Role: primary
Giuseppe Daidone
Role: primary
Goffredo Del Rosso
Role: primary
Luigi Biancone
Role: primary
Dario Roccatello
Role: primary
Giuliano Brunori
Role: primary
Silvia Cassamali
Role: primary
Fabio Milanesi
Role: primary
Other Identifiers
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RF-2010-2314193
Identifier Type: -
Identifier Source: org_study_id
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