Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
146 participants
INTERVENTIONAL
2003-11-30
2008-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Dialysate Cooling Versus Sodium Profiling in Management of Intradialytic Hypotension Among Chronic Hemodialysis Patients
NCT06890195
The Benefit of Оn-Line High Convection Volume Hemodiafiltration Treatment Versus High Flow Dialysis on Reduction of Oxidative Stress and Health Related Quality of Life in Dialysis Patients
NCT02673099
Effects of Variation of Sodium Dialysate in ICU
NCT03329313
Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis
NCT06556407
Reducing Dialysate Sodium Effect on Blood Pressure Variability in Hemodialysis Patients
NCT05169125
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
low-flux hemodialysis
No interventions assigned to this group
online pre-dilution hemofiltration
online pre-dilution hemofiltration
Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one
online pre-dilution hemodiafiltration
online pre-dilution hemodiafiltration
Online pre-dilution hemodiafiltration was performed with a synthetic high-flux membrane with an infusate/blood flow ratio of 0.6 and a dialysate plus infusate rate of 700 ml/min.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
online pre-dilution hemofiltration
Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one
online pre-dilution hemodiafiltration
Online pre-dilution hemodiafiltration was performed with a synthetic high-flux membrane with an infusate/blood flow ratio of 0.6 and a dialysate plus infusate rate of 700 ml/min.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
A. Manzoni Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Francesco Locatelli
Professor Francesco Locatelli
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francesco Locatelli, Professor
Role: STUDY_CHAIR
A. Manzoni Hospital, Lecco - Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedale S.Marta S.Venera
Acireale (CT), , Italy
Ospedale F. Miulli
Acquaviva delle Fonti, , Italy
Ospedale Civile
Alghero, , Italy
Ospedale regionale di Aosta
Aosta, , Italy
Ospedale degli Infermi
Biella, , Italy
Ospedale SS. Trinità ASL 8
Cagliari, , Italy
S. Michele Hospital
Cagliari, , Italy
Ospedale Civile "P. Merlo"
La Maddalena, , Italy
Alessandro Manzoni Hospital
Lecco, , Italy
Ospedale "C. POMA"
Mantova, , Italy
T. EVOLI
Melito di Porto Salvo, , Italy
Ospedale dell'Angelo
Mestre, , Italy
Policlinico Multimedica IRCCS
Milan, , Italy
Federico II
Napoli, , Italy
Ospedale San Francesco
Nuoro, , Italy
San Giovanni di Dio
Olbia, , Italy
Ospedale Antonio Segni
Ozieri, , Italy
Ospedale Maggiore
Parma, , Italy
Fondazione Maugeri
Pavia, , Italy
Ospedale " E. AGNELLI "
Pinerolo, , Italy
Dipartimento territoriale ASL 8
Quartu Sant'Elena, , Italy
Ospedale S.Maria delle Croci
Ravenna, , Italy
Azienda Ospedaliera "Bianchi Melacrino Morelli,"
Reggio Calabria, , Italy
Ospedale Bolognini
Seriate, , Italy
Ospedale Agostino Landolfi
Solofra, , Italy
Ospedale San Camillo
Sorgono, , Italy
ASL 2 Olbia - P.O. "P. Dettori",
Tempio Pausania, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CONVESTUDY
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.