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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
144
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
AUO Policlinico Consorziale
Bari, BA, Italy
RECRUITINGOspedale Santa Marta e Santa Venera di Acireale
Acireale, Italy
NOT_YET_RECRUITINGA.O.U. Ospedali Riuniti di Ancona
Ancona, Italy
NOT_YET_RECRUITINGPresidio Ospedaliero 1 - Arezzo, "San Donato"
Arezzo, Italy
RECRUITINGmean quality-adjusted life year (QALY) score in the first year after the start of dialysis
Time frame: one year
dialysis related cost of care
Time frame: one year
transportation costs per patient per year for the journeys "home-hospital-home"
Time frame: one year
ratio nurse/patients
Time frame: one year
hospitalization rate (admissions and days
Time frame: one year
weekly standardized Kt/V delivered
Time frame: one year
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
Time frame: one year
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
Time frame: one year
maintenance of residual renal function
it will be assessed residual diuresis per day expressed in ml and residual creatinine clearance expressed in ml/min
Time frame: one year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Policlinico Universitario S. Orsola-Malpighi
Bologna, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera G. Brotzu
Cagliari, Italy
NOT_YET_RECRUITINGOspedale S. Giacomo Apostolo
Castelfranco Veneto, Italy
RECRUITINGOspedale per l'emergenza Cannizzaro Catania
Catania, Italy
NOT_YET_RECRUITINGOspedale SS.Annunziata
Chieti, Italy
NOT_YET_RECRUITINGOspedale Civile di Cremona
Cremona, Italy
NOT_YET_RECRUITING...and 21 more locations