Clinical trial NCT01583309: Effects of Convective Therapies in Dialysis Patients
Official title: Effects of Convective Therapies in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uremia
Keywords: blood pressure
cardiovascular instability
symptomatic hypotension
online hemofiltration
online hemodiafiltration
Lead sponsor: A. Manzoni Hospital
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Convective therapies have been proposed for improving chronic dialysis patient outcomes, including intradialytic symptomatic hypotension.

To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different types and doses of convective therapies compared with low-flux hemodialysis (HD), the investigators performed a multicentre, open-label, randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Dialysis patients aged 18-80 years
* thrice-weekly HD or HDF for at least 6 months
* body weight less or equal to 90 Kg
* stable clinical condition
* written consent

Exclusion Criteria:

* infections
* malignancies
* active systemic diseases
* active hepatitis or cirrhosis
* unstable diabetes
* diuresis higher than 200 ml/24h
* dysfunction of vascular access
* blood flow rate less than 300 ml/min

Primary outcomes:
measure: Intradialytic symptomatic hypotension
timeFrame: all dialysis sessions, three per week, for 2 years
Secondary outcomes:
measure: Resistance to erythropoiesis-stimulating agents
timeFrame: Monthly for 2 years
measure: Calcium-phosphate metabolism
timeFrame: Monthly for 2 years
measure: Beta2 microglobulin
timeFrame: Every six months for 2 years
Other outcomes:
Locations:
city: Acireale (CT)
country: Italy
facility: Ospedale S.Marta S.Venera
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale F. Miulli
city: Alghero
country: Italy
facility: Ospedale Civile
city: Aosta
country: Italy
facility: Ospedale regionale di Aosta
city: Biella
country: Italy
facility: Ospedale degli Infermi
city: Cagliari
country: Italy
facility: Ospedale SS. Trinità ASL 8
city: Cagliari
country: Italy
facility: S. Michele Hospital
city: La maddalena
country: Italy
facility: Ospedale Civile "P. Merlo"
city: Lecco
country: Italy
facility: Alessandro Manzoni Hospital
city: Mantova
country: Italy
facility: Ospedale "C. POMA"
city: Melito Porto Salvo
country: Italy
facility: T. EVOLI
city: Mestre
country: Italy
facility: Ospedale dell'Angelo
city: Milano
country: Italy
facility: Policlinico Multimedica IRCCS
city: Napoli
country: Italy
facility: Federico II
city: Nuoro
country: Italy
facility: Ospedale San Francesco
city: Olbia
country: Italy
facility: San Giovanni di Dio
city: Ozieri
country: Italy
facility: Ospedale Antonio Segni
city: Parma
country: Italy
facility: Ospedale Maggiore
city: Pavia
country: Italy
facility: Fondazione Maugeri
city: Pinerolo
country: Italy
facility: Ospedale " E. AGNELLI "
city: Quartu Sant'Elena
country: Italy
facility: Dipartimento territoriale ASL 8
city: Ravenna
country: Italy
facility: Ospedale S.Maria delle Croci
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera "Bianchi Melacrino Morelli,"
city: Seriate
country: Italy
facility: Ospedale Bolognini
city: Solofra
country: Italy
facility: Ospedale Agostino Landolfi
city: Sorgono
country: Italy
facility: Ospedale San Camillo
city: Tempio Pausania
country: Italy
facility: ASL 2 Olbia - P.O. "P. Dettori",
Study officials:
affiliation: A. Manzoni Hospital, Lecco - Italy
name: Francesco Locatelli, Professor
role: STUDY_CHAIR
References:
citation: Bolasco P, Altieri P, Andrulli S, Basile C, Di Filippo S, Feriani M, Pedrini L, Santoro A, Zoccali C, Sau G, Locatelli F. Convection versus diffusion in dialysis: an Italian prospective multicentre study. Nephrol Dial Transplant. 2003 Aug;18 Suppl 7:vii50-4; discussion vii59-62. doi: 10.1093/ndt/gfg1080.
citation: Locatelli F, Altieri P, Andrulli S, Bolasco P, Sau G, Pedrini LA, Basile C, David S, Feriani M, Montagna G, Di Iorio BR, Memoli B, Cravero R, Battaglia G, Zoccali C. Hemofiltration and hemodiafiltration reduce intradialytic hypotension in ESRD. J Am Soc Nephrol. 2010 Oct;21(10):1798-807. doi: 10.1681/ASN.2010030280. Epub 2010 Sep 2.
citation: Locatelli F, Altieri P, Andrulli S, Sau G, Bolasco P, Pedrini LA, Basile C, David S, Gazzanelli L, Tampieri G, Isola E, Marzolla O, Memoli B, Ganadu M, Reina E, Bertoli S, Ferrara R, Casu D, Logias F, Tarchini R, Mattana G, Passaghe M, Fundoni G, Villa G, Di Iorio BR, Pontoriero G, Zoccali C. Phosphate levels in patients treated with low-flux haemodialysis, pre-dilution haemofiltration and haemodiafiltration: post hoc analysis of a multicentre, randomized and controlled trial. Nephrol Dial Transplant. 2014 Jun;29(6):1239-46. doi: 10.1093/ndt/gfu031. Epub 2014 Feb 20.