Clinical trial NCT02002949: Conventional Hemodialysis Vs Short Daily Hemodialysis for Patients Coming From Peritoneal Dialysis (HAPD/CAPD)
Official title: Cost-Utility of Conventional Hemodialysis (CHD) Vs Short Daily Hemodialysis (SDHD) for Patients Coming From Peritoneal Dialysis (HAPD/CAPD): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Hemodialysis
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: Conventional Hemodialysis - 3 treatments per week for approximately 4 hours- will be performed in a dialysis clinic using any hemodialysis machine. Short Daily Hemodialysis - 5 or 6 treatments per week for approximately 2-4 hours per treatment- will be performed in the patient's home, using any hemodialysis machine. Partecipants randomized to SDHD will undergo an intensive home hemodialysis training program expected to take 2-6 weeks to complete. Qualified healthcare professionals will train each SDHD subject's partner to perform dialysis using any hemodialysis machine as chosen by clinicians. At baseline visit, before the first study treatment in either the SDHD or CHD arm, the following data will be collected: demographic information, ESRD history, EuroQol EQ-5D-5L questionnaire, vital sign, blood laboratory test results, KT/V parameters, 24 hour timed urine collection test results, comorbid conditions, vascular access type, current medications. After hemodialysis start, patients will be followed up to 12 months with data collection at 1,3,6 and 12 months. At each visit, the following data will be collected: EuroQol EQ-5D-5L questionnaire, vital sign, blood laboratory test results, KT/V parameters, 24 hour timed urine collection test results, adverse events, vascular access type, current medications. During this study, the following parameters will be strictly monitored: treatment costs, medications, number of hospitalization admissions, number of days in hospital and reasons for hospitalizations, additional costs informations.

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of end-stage renal disease
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:

1. Current enrollment in another investigational drug or device trial which might impact the outcomes measures planned in this study.
2. Being scheduled for change of modality or plans to relocate to an area outside of the clinical center.
3. Cancer
4. Pregnancy-lactation.

Primary outcomes:
measure: mean quality-adjusted life year (QALY) score in the first year after the start of dialysis
timeFrame: one year
Secondary outcomes:
measure: dialysis related cost of care
timeFrame: one year
measure: transportation costs per patient per year for the journeys "home-hospital-home"
timeFrame: one year
measure: ratio nurse/patients
timeFrame: one year
measure: hospitalization rate (admissions and days
timeFrame: one year
measure: weekly standardized Kt/V delivered
timeFrame: one year
measure: systolic blood pressure and use of antihypertensive medications
timeFrame: one year
measure: mineral metabolism, anemia parameters and nutritional parameters
timeFrame: one year
measure: maintenance of residual renal function
timeFrame: one year
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AUO Policlinico Consorziale
state: BA
city: Acireale
country: Italy
facility: Ospedale Santa Marta e Santa Venera di Acireale
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti di Ancona
city: Arezzo
country: Italy
facility: Presidio Ospedaliero 1 - Arezzo, "San Donato"
city: Bologna
country: Italy
facility: Policlinico Universitario S. Orsola-Malpighi
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu
city: Castelfranco Veneto
country: Italy
facility: Ospedale S. Giacomo Apostolo
city: Catania
country: Italy
facility: Ospedale per l'emergenza Cannizzaro Catania
city: Chieti
country: Italy
facility: Ospedale SS.Annunziata
city: Cremona
country: Italy
facility: Ospedale Civile di Cremona
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria "OO.RR." di Foggia
city: Lido di Camaiore
country: Italy
facility: ASL 12 Di Viareggio - Ospedale Versilia
city: Napoli
country: Italy
facility: Seconda Università degli Studi di Napoli
city: Napoli
country: Italy
facility: Secondo Policlinico-Azienda Ospedaliera Universitaria "Federico II"
city: Nuoro
country: Italy
facility: Secondo Ospedale S. Francesco, ASL 3 S
city: Pescara
country: Italy
facility: Ospedale Civile Spirito Santo
city: Piacenza
country: Italy
facility: Ospedale Civile di Piacenza
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Roma
country: Italy
facility: Ospedale G. B. Grassi
city: Roma
country: Italy
facility: Università Cattolica Del Sacro Cuore
city: Rovigo
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: San Fermo della Battaglia
country: Italy
facility: Ospedale D. Anna
city: San Michele
country: Italy
facility: Ospedale Civile San Giovanni Di Dio
city: Senigallia
country: Italy
facility: Ospedale Principe di Piemonte
city: Siracusa
country: Italy
facility: Ospedale Umberto I di Siracusa
city: Teramo
country: Italy
facility: Ospedale Mazzini
city: Torino
country: Italy
facility: Ospedale San giovanni Battista Molinette
city: Torino
country: Italy
facility: Ospedale San giovanni Bosco
city: Trento
country: Italy
facility: Ospedale Santa Chiara
city: Treviglio
country: Italy
facility: Ospedale Treviglio - Caravaggio
city: Voghera
country: Italy
facility: Ospedale Civile di Voghera
Study officials:
affiliation: AOUConsorziale, Bari, Italy
name: Loreto LG GESUALDO, MD
role: PRINCIPAL_INVESTIGATOR
References: