Effects of Convective Therapies in Dialysis Patients
ECTDP
1 other identifier
interventional
146
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2003
Typical duration for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 17, 2012
CompletedFirst Posted
Study publicly available on registry
April 24, 2012
CompletedApril 24, 2012
April 1, 2012
4.3 years
April 17, 2012
April 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intradialytic symptomatic hypotension
Intradialytic symptomatic hypotension was defined as a rapid symptomatic fall of the systolic blood pressure by at least 30 mmHg or that required nursing and/or medical intervention
all dialysis sessions, three per week, for 2 years
Secondary Outcomes (3)
Resistance to erythropoiesis-stimulating agents
Monthly for 2 years
Calcium-phosphate metabolism
Monthly for 2 years
Beta2 microglobulin
Every six months for 2 years
Study Arms (3)
low-flux hemodialysis
NO INTERVENTIONonline pre-dilution hemofiltration
EXPERIMENTALonline pre-dilution hemodiafiltration
EXPERIMENTALInterventions
Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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
Related Publications (3)
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.
PMID: 12953031BACKGROUNDLocatelli 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.
PMID: 20813866RESULTLocatelli 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.
PMID: 24557989DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Francesco Locatelli, Professor
A. Manzoni Hospital, Lecco - Italy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Francesco Locatelli
Study Record Dates
First Submitted
April 17, 2012
First Posted
April 24, 2012
Study Start
November 1, 2003
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
April 24, 2012
Record last verified: 2012-04