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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Unknown

Conditions: End Stage Renal Disease

Treatments: Procedure: Conventional hemodialysis; Procedure: Short daily hemodialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02002949

RF-2010-2314193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

144 participants in 2 patient groups

Short daily hemodialsysis

Experimental group

Description:

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

Treatment:

Procedure: Short daily hemodialysis

Conventional hemodialysis

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional hemodialysis