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

Not Applicable

• Conditions: End Stage Renal Disease
• Interventions: Procedure: Conventional hemodialysis; Procedure: Short daily hemodialysis

• Registration Number: NCT02002949
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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.

Study Timeline

• Study First Submitted: 2013-11-20
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Study Start: 2014-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09
• Primary Completion: 2016-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional hemodialysis	Conventional hemodialysis	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
Short daily hemodialsysis	Short daily hemodialysis	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

Primary Outcome Measures

Name	Time	Method
mean quality-adjusted life year (QALY) score in the first year after the start of dialysis	one year

Secondary Outcome Measures

Name	Time	Method
hospitalization rate (admissions and days	one year
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
systolic blood pressure and use of antihypertensive medications	one year	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
weekly standardized Kt/V delivered	one year
maintenance of residual renal function	one year	it will be assessed residual diuresis per day expressed in ml and residual creatinine clearance expressed in ml/min
mineral metabolism, anemia parameters and nutritional parameters	one year	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

Trial Locations

Locations (31)

AUO Policlinico Consorziale; 🇮🇹 Bari, BA, Italy

Azienda Ospedaliera G. Brotzu; 🇮🇹 Cagliari, Italy

Policlinico Universitario S. Orsola-Malpighi; 🇮🇹 Bologna, Italy

A.O.U. Ospedali Riuniti di Ancona; 🇮🇹 Ancona, Italy

Ospedale Santa Marta e Santa Venera di Acireale; 🇮🇹 Acireale, Italy

Ospedale Civile Spirito Santo; 🇮🇹 Pescara, Italy

Azienda Ospedaliera Universitaria Pisana; 🇮🇹 Pisa, Italy

Ospedale Santa Chiara; 🇮🇹 Trento, Italy

Ospedale S. Giacomo Apostolo; 🇮🇹 Castelfranco Veneto, Italy

Ospedale Umberto I di Siracusa; 🇮🇹 Siracusa, Italy

Azienda Ospedaliero Universitaria "OO.RR." di Foggia; 🇮🇹 Foggia, Italy

ASL 12 Di Viareggio - Ospedale Versilia; 🇮🇹 Lido di Camaiore, Italy

Ospedale Civile di Piacenza; 🇮🇹 Piacenza, Italy

Università Cattolica Del Sacro Cuore; 🇮🇹 Roma, Italy

Ospedale Santa Maria della Misericordia; 🇮🇹 Rovigo, Italy

Ospedale D. Anna; 🇮🇹 San Fermo della Battaglia, Italy

Ospedale Principe di Piemonte; 🇮🇹 Senigallia, Italy

Ospedale San giovanni Battista Molinette; 🇮🇹 Torino, Italy

Ospedale Treviglio - Caravaggio; 🇮🇹 Treviglio, Italy

Ospedale Civile di Voghera; 🇮🇹 Voghera, Italy

Presidio Ospedaliero 1 - Arezzo, "San Donato"; 🇮🇹 Arezzo, Italy

Ospedale per l'emergenza Cannizzaro Catania; 🇮🇹 Catania, Italy

Ospedale SS.Annunziata; 🇮🇹 Chieti, Italy

Ospedale Civile di Cremona; 🇮🇹 Cremona, 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 G. B. Grassi; 🇮🇹 Roma, Italy

Ospedale Civile San Giovanni Di Dio; 🇮🇹 San Michele, Italy

Ospedale Mazzini; 🇮🇹 Teramo, Italy

Ospedale San giovanni Bosco; 🇮🇹 Torino, Italy