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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cost-Utility of Conventional Hemodialysis (CHD) Vs Short Daily Hemodialysis (SDHD) for Patients Coming From Peritoneal Dialysis (HAPD/CAPD): A Randomized Controlled Trial

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Procedure: Short daily hemodialysis
* Procedure: Conventional hemodialysis


Participation Criteria
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Eligibility Criteria
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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: 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. Expected survival of at least one year. Ability to understand and willingness to sign an informed consent statement. Exclusion Criteria: Current enrollment in another investigational drug or device trial which might impact the outcomes measures planned in this study. Being scheduled for change of modality or plans to relocate to an area outside of the clinical center. Cancer Pregnancy-lactation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short daily hemodialsysis<br>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 | Procedure: Short daily hemodialysis<br>* 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<br>|
| Active Comparator: Conventional hemodialysis<br>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 | Procedure: Conventional hemodialysis<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean quality-adjusted life year (QALY) score in the first year after the start of dialysis |  | one year | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis