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

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (Other)

Overall Status

Unknown status

CT.gov ID

NCT02002949

Collaborator

(none)

144

Enrollment

Locations

Arms

Duration (Months)

4.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Procedure: Short daily hemodialysis Procedure: Conventional hemodialysis	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Nov 1, 2016

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

mean quality-adjusted life year (QALY) score in the first year after the start of dialysis [one year]

Secondary Outcome Measures

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 [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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AUO Policlinico Consorziale	Bari	BA	Italy	70125
2	Ospedale Santa Marta e Santa Venera di Acireale	Acireale		Italy
3	A.O.U. Ospedali Riuniti di Ancona	Ancona		Italy
4	Presidio Ospedaliero 1 - Arezzo, "San Donato"	Arezzo		Italy
5	Policlinico Universitario S. Orsola-Malpighi	Bologna		Italy
6	Azienda Ospedaliera G. Brotzu	Cagliari		Italy
7	Ospedale S. Giacomo Apostolo	Castelfranco Veneto		Italy
8	Ospedale per l'emergenza Cannizzaro Catania	Catania		Italy
9	Ospedale SS.Annunziata	Chieti		Italy
10	Ospedale Civile di Cremona	Cremona		Italy
11	Azienda Ospedaliero Universitaria "OO.RR." di Foggia	Foggia		Italy
12	ASL 12 Di Viareggio - Ospedale Versilia	Lido di Camaiore		Italy
13	Seconda Università degli Studi di Napoli	Napoli		Italy
14	Secondo Policlinico-Azienda Ospedaliera Universitaria "Federico II"	Napoli		Italy
15	Secondo Ospedale S. Francesco, ASL 3 S	Nuoro		Italy
16	Ospedale Civile Spirito Santo	Pescara		Italy
17	Ospedale Civile di Piacenza	Piacenza		Italy
18	Azienda Ospedaliera Universitaria Pisana	Pisa		Italy
19	Ospedale G. B. Grassi	Roma		Italy
20	Università Cattolica Del Sacro Cuore	Roma		Italy
21	Ospedale Santa Maria della Misericordia	Rovigo		Italy
22	Ospedale D. Anna	San Fermo della Battaglia		Italy
23	Ospedale Civile San Giovanni Di Dio	San Michele		Italy
24	Ospedale Principe di Piemonte	Senigallia		Italy
25	Ospedale Umberto I di Siracusa	Siracusa		Italy
26	Ospedale Mazzini	Teramo		Italy
27	Ospedale San giovanni Battista Molinette	Torino		Italy
28	Ospedale San giovanni Bosco	Torino		Italy
29	Ospedale Santa Chiara	Trento		Italy
30	Ospedale Treviglio - Caravaggio	Treviglio		Italy
31	Ospedale Civile di Voghera	Voghera		Italy

Sponsors and Collaborators

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Loreto GESUALDO, FULL PROFESSOR, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

ClinicalTrials.gov Identifier:

NCT02002949

Other Study ID Numbers:

RF-2010-2314193

First Posted:

Dec 6, 2013

Last Update Posted:

Mar 9, 2016

Last Verified:

Mar 1, 2016

Keywords provided by Loreto GESUALDO, FULL PROFESSOR, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Hemodialysis

Additional relevant MeSH terms:

Kidney Failure, Chronic

Study Results

No Results Posted as of Mar 9, 2016