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

March 8, 2016 updated by: Loreto GESUALDO, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Acireale, Italy
        • Not yet recruiting
        • Ospedale Santa Marta e Santa Venera di Acireale
        • Contact:
          • Giovanni Giorgio Battaglia
      • Ancona, Italy
        • Not yet recruiting
        • A.O.U. Ospedali Riuniti di Ancona
        • Contact:
          • Giovanni Frascà
      • Arezzo, Italy
        • Recruiting
        • Presidio Ospedaliero 1 - Arezzo, "San Donato"
        • Contact:
          • Ennio Duranti
      • Bologna, Italy
        • Not yet recruiting
        • Policlinico Universitario S. Orsola-Malpighi
        • Contact:
          • Gaetano La Manna
      • Cagliari, Italy
        • Not yet recruiting
        • Azienda Ospedaliera G. Brotzu
        • Contact:
          • Antonello Pani
      • Castelfranco Veneto, Italy
        • Recruiting
        • Ospedale S. Giacomo Apostolo
        • Contact:
          • Cataldo Abaterusso
      • Catania, Italy
        • Not yet recruiting
        • Ospedale per l'emergenza Cannizzaro Catania
        • Contact:
          • Massimo Matalone
      • Chieti, Italy
        • Not yet recruiting
        • Ospedale SS.Annunziata
        • Contact:
          • Mario Bonomini
      • Cremona, Italy
        • Not yet recruiting
        • Ospedale Civile di Cremona
        • Contact:
          • Fabio Malberti
      • Foggia, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria "OO.RR." di Foggia
        • Contact:
          • Giuseppe Grandaliano
      • Lido di Camaiore, Italy
        • Recruiting
        • ASL 12 Di Viareggio - Ospedale Versilia
        • Contact:
          • Vincenzo Panichi
      • Napoli, Italy
        • Recruiting
        • Seconda Università degli Studi di Napoli
        • Contact:
          • Giovambattista Capasso
      • Napoli, Italy
        • Not yet recruiting
        • Secondo Policlinico-Azienda Ospedaliera Universitaria "Federico II"
        • Contact:
          • Stefano Federico
      • Nuoro, Italy
        • Not yet recruiting
        • Secondo Ospedale S. Francesco, ASL 3 S
        • Contact:
          • Maria Maddalena Sedda
      • Pescara, Italy
        • Not yet recruiting
        • Ospedale Civile Spirito Santo
        • Contact:
          • Mario Campanella
      • Piacenza, Italy
        • Not yet recruiting
        • Ospedale Civile Di Piacenza
        • Contact:
          • Roberto Scarpioni
      • Pisa, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Pisana
        • Contact:
          • Francesca Egidi
      • Roma, Italy
        • Not yet recruiting
        • Ospedale G. B. Grassi
        • Contact:
          • Massimo Morosetti
      • Roma, Italy
        • Recruiting
        • Università Cattolica del Sacro Cuore
        • Contact:
          • Giovanni Gambaro
      • Rovigo, Italy
        • Not yet recruiting
        • Ospedale Santa Maria Della Misericordia
        • Contact:
          • Fulvio Fiorini
      • San Fermo della Battaglia, Italy
        • Recruiting
        • Ospedale D. Anna
        • Contact:
          • Claudio Minoretti
      • San Michele, Italy
        • Not yet recruiting
        • Ospedale Civile San Giovanni di Dio
        • Contact:
          • Antonio Granata
      • Senigallia, Italy
        • Not yet recruiting
        • Ospedale Principe di Piemonte
        • Contact:
          • Rolando Boggi
      • Siracusa, Italy
        • Not yet recruiting
        • Ospedale Umberto I di Siracusa
        • Contact:
          • Giuseppe Daidone
      • Teramo, Italy
        • Not yet recruiting
        • Ospedale Mazzini
        • Contact:
          • Goffredo Del Rosso
      • Torino, Italy
        • Not yet recruiting
        • Ospedale San Giovanni Battista Molinette
        • Contact:
          • Luigi Biancone
      • Torino, Italy
        • Not yet recruiting
        • Ospedale San Giovanni Bosco
        • Contact:
          • Dario Roccatello
      • Trento, Italy
        • Not yet recruiting
        • Ospedale Santa Chiara
        • Contact:
          • Giuliano Brunori
      • Treviglio, Italy
        • Recruiting
        • Ospedale Treviglio - Caravaggio
        • Contact:
          • Silvia Cassamali
      • Voghera, Italy
        • Recruiting
        • Ospedale Civile di Voghera
        • Contact:
          • Fabio Milanesi
    • BA
      • Bari, BA, Italy, 70125
        • Recruiting
        • AUO Policlinico Consorziale
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short daily hemodialsysis
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
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
Active Comparator: 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
Procedure: Conventional hemodialysis
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dialysis related cost of care
Time Frame: one year
one year
transportation costs per patient per year for the journeys "home-hospital-home"
Time Frame: one year
one year
ratio nurse/patients
Time Frame: one year
one year
hospitalization rate (admissions and days
Time Frame: one year
one year
weekly standardized Kt/V delivered
Time Frame: one year
one year
systolic blood pressure and use of antihypertensive medications
Time Frame: 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
one year
mineral metabolism, anemia parameters and nutritional parameters
Time Frame: 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
one year
maintenance of residual renal function
Time Frame: one year
it will be assessed residual diuresis per day expressed in ml and residual creatinine clearance expressed in ml/min
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Investigators

  • Principal Investigator: Loreto LG GESUALDO, MD, AOUConsorziale, Bari, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

December 2, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RF-2010-2314193

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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