Conventional Hemodialysis Vs Short Daily Hemodialysis for Patients Coming From Peritoneal Dialysis (HAPD/CAPD)

End Stage Renal Disease Clinical Trial

— CHDvsSDHD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02002949
• Other study ID #: RF-2010-2314193
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2013
• Last updated: March 8, 2016
• Start date: February 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: Azienda Ospedaliero-Universitaria Consorziale
• Contact: Loreto GESUALDO, MD
• Phone: +39 080 559
• Email: loreto.gesualdo[@]uniba.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
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	AUO Policlinico Consorziale	Bari	BA
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	Siracusa
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

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean quality-adjusted life year (QALY) score in the first year after the start of dialysis		one year	No
Secondary	dialysis related cost of care		one year	No
Secondary	transportation costs per patient per year for the journeys "home-hospital-home"		one year	No
Secondary	ratio nurse/patients		one year	No
Secondary	hospitalization rate (admissions and days		one year	No
Secondary	weekly standardized Kt/V delivered		one year	No
Secondary	systolic blood pressure and use of antihypertensive medications	blood pressure will be assessed for a year and measured in mmHg. It will be evaluated if the patient will need to increase the antihypertensive therapy or to reduce it	one year	No
Secondary	mineral metabolism, anemia parameters and nutritional parameters	As of mineral metabolism, it will be assessed serum calcium levels (expressed in mg per deciliter), serum phosphorus levels (expressed in mg per deciliter), parathormone levels (expressed in pg/ml). As of anemia, it will evaluated hemoglobin levels (expressed in g per deciliter), hematocrit (expressed in %), serum ferritin (µg/l) , transferrin saturation (expressed in %). Albumin (g/dl) will be a nutritional parameter	one year	No
Secondary	maintenance of residual renal function	it will be assessed residual diuresis per day expressed in ml and residual creatinine clearance expressed in ml/min	one year	No