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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short daily hemodialsysis | Experimental | 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 |
|
| Conventional hemodialysis | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short daily hemodialysis | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| mean quality-adjusted life year (QALY) score in the first year after the start of dialysis | one year |
| Measure | Description | Time Frame |
|---|---|---|
| dialysis related cost of care | one year | |
| transportation costs per patient per year for the journeys "home-hospital-home" | one year | |
| ratio nurse/patients |
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Inclusion Criteria:
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:
Expected survival of at least one year.
Ability to understand and willingness to sign an informed consent statement.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Loreto GESUALDO, MD | Contact | +39 080 559 | 4041 | loreto.gesualdo@uniba.it |
| Name | Affiliation | Role |
|---|---|---|
| Loreto LG GESUALDO, MD | AOUConsorziale, Bari, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AUO Policlinico Consorziale | Recruiting | Bari | BA | 70125 | Italy |
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| Conventional hemodialysis | Procedure | 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 |
|
| one year |
| hospitalization rate (admissions and days | one year |
| weekly standardized Kt/V delivered | 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 | 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 | 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 | one year |
| Ospedale Santa Marta e Santa Venera di Acireale | Not yet recruiting | Acireale | Italy |
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| A.O.U. Ospedali Riuniti di Ancona | Not yet recruiting | Ancona | Italy |
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| Presidio Ospedaliero 1 - Arezzo, "San Donato" | Recruiting | Arezzo | Italy |
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| Policlinico Universitario S. Orsola-Malpighi | Not yet recruiting | Bologna | Italy |
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| Azienda Ospedaliera G. Brotzu | Not yet recruiting | Cagliari | Italy |
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| Ospedale S. Giacomo Apostolo | Recruiting | Castelfranco Veneto | Italy |
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| Ospedale per l'emergenza Cannizzaro Catania | Not yet recruiting | Catania | Italy |
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| Ospedale SS.Annunziata | Not yet recruiting | Chieti | Italy |
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| Ospedale Civile di Cremona | Not yet recruiting | Cremona | Italy |
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| Azienda Ospedaliero Universitaria "OO.RR." di Foggia | Recruiting | Foggia | Italy |
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| ASL 12 Di Viareggio - Ospedale Versilia | Recruiting | Lido di Camaiore | Italy |
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| Seconda Università degli Studi di Napoli | Recruiting | Naples | Italy |
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| Secondo Policlinico-Azienda Ospedaliera Universitaria "Federico II" | Not yet recruiting | Naples | Italy |
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| Secondo Ospedale S. Francesco, ASL 3 S | Not yet recruiting | Nuoro | Italy |
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| Ospedale Civile Spirito Santo | Not yet recruiting | Pescara | Italy |
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| Ospedale Civile di Piacenza | Not yet recruiting | Piacenza | Italy |
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| Azienda Ospedaliera Universitaria Pisana | Not yet recruiting | Pisa | Italy |
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| Ospedale G. B. Grassi | Not yet recruiting | Roma | Italy |
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| Università Cattolica Del Sacro Cuore | Recruiting | Roma | Italy |
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| Ospedale Santa Maria della Misericordia | Not yet recruiting | Rovigo | Italy |
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| Ospedale D. Anna | Recruiting | San Fermo della Battaglia | Italy |
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| Ospedale Civile San Giovanni Di Dio | Not yet recruiting | San Michele | Italy |
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| Ospedale Principe di Piemonte | Not yet recruiting | Senigallia | Italy |
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| Ospedale Umberto I di Siracusa | Not yet recruiting | Syracuse | Italy |
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| Ospedale Mazzini | Not yet recruiting | Teramo | Italy |
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| Ospedale San giovanni Battista Molinette | Not yet recruiting | Torino | Italy |
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| Ospedale San giovanni Bosco | Not yet recruiting | Torino | Italy |
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| Ospedale Santa Chiara | Not yet recruiting | Trento | Italy |
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| Ospedale Treviglio - Caravaggio | Recruiting | Treviglio | Italy |
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| Ospedale Civile di Voghera | Recruiting | Voghera | Italy |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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