Conventional Hemodialysis Vs Short Daily Hemodialysis for Patients Coming From Peritoneal Dialysis (HAPD/CAPD)
CHDvsSDHD
Cost-Utility of Conventional Hemodialysis (CHD) Vs Short Daily Hemodialysis (SDHD) for Patients Coming From Peritoneal Dialysis (HAPD/CAPD): A Randomized Controlled Trial
1 other identifier
interventional
144
1 country
31
Brief Summary
The purpose of this randomized study is to determine if the home SDHD is a suitable alternative to conventional dialysis performed in a dialysis center for patients suffering from chronic kidney disease from Peritoneal Dialysis (HAPD/CAPD). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 9, 2016
March 1, 2016
2.8 years
November 20, 2013
March 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mean quality-adjusted life year (QALY) score in the first year after the start of dialysis
one year
Secondary Outcomes (8)
dialysis related cost of care
one year
transportation costs per patient per year for the journeys "home-hospital-home"
one year
ratio nurse/patients
one year
hospitalization rate (admissions and days
one year
weekly standardized Kt/V delivered
one year
- +3 more secondary outcomes
Study Arms (2)
Short daily hemodialsysis
EXPERIMENTALShort 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
Conventional hemodialysis
ACTIVE COMPARATORConventional 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
Interventions
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
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
You may qualify if:
- Diagnosis of end-stage renal disease
- Currently performing Peritoneal Dialysis (HAPD and CAPD) for a minimum of 3 months.
- Age 18 years or older.
- 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.
- Expected survival of at least one year.
- Ability to understand and willingness to sign an informed consent statement.
You may not qualify if:
- Current enrollment in another investigational drug or device trial which might impact the outcomes measures planned in this study.
- Being scheduled for change of modality or plans to relocate to an area outside of the clinical center.
- Cancer
- Pregnancy-lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
AUO Policlinico Consorziale
Bari, BA, 70125, 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 Santa Chiara
Trento, Italy
Ospedale Treviglio - Caravaggio
Treviglio, Italy
Ospedale Civile di Voghera
Voghera, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Loreto LG GESUALDO, MD
AOUConsorziale, Bari, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- FULL PROFESSOR
Study Record Dates
First Submitted
November 20, 2013
First Posted
December 6, 2013
Study Start
February 1, 2014
Primary Completion
November 1, 2016
Study Completion
December 1, 2017
Last Updated
March 9, 2016
Record last verified: 2016-03