- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01583309
Effects of Convective Therapies in Dialysis Patients (ECTDP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Acireale (CT), Italy
- Ospedale S.Marta S.Venera
-
Acquaviva delle Fonti, Italy
- Ospedale F. Miulli
-
Alghero, Italy
- Ospedale Civile
-
Aosta, Italy
- Ospedale regionale di Aosta
-
Biella, Italy
- Ospedale degli Infermi
-
Cagliari, Italy
- Ospedale SS. Trinità ASL 8
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Cagliari, Italy
- S. Michele Hospital
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La maddalena, Italy
- Ospedale Civile "P. Merlo"
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Lecco, Italy
- Alessandro Manzoni Hospital
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Mantova, Italy
- Ospedale "C. POMA"
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Melito Porto Salvo, Italy
- T. EVOLI
-
Mestre, Italy
- Ospedale dell'Angelo
-
Milano, Italy
- Policlinico Multimedica IRCCS
-
Napoli, Italy
- Federico II
-
Nuoro, Italy
- Ospedale San Francesco
-
Olbia, Italy
- San Giovanni Di Dio
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Ozieri, Italy
- Ospedale Antonio Segni
-
Parma, Italy
- Ospedale Maggiore
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Pavia, Italy
- Fondazione Maugeri
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Pinerolo, Italy
- Ospedale " E. AGNELLI "
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Quartu Sant'Elena, Italy
- Dipartimento territoriale ASL 8
-
Ravenna, Italy
- Ospedale S.Maria delle Croci
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Reggio Calabria, Italy
- Azienda Ospedaliera "Bianchi Melacrino Morelli,"
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Seriate, Italy
- Ospedale Bolognini
-
Solofra, Italy
- Ospedale Agostino Landolfi
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Sorgono, Italy
- Ospedale San Camillo
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Tempio Pausania, Italy
- ASL 2 Olbia - P.O. "P. Dettori",
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: low-flux hemodialysis
|
|
Experimental: online pre-dilution hemofiltration
|
Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one
Other Names:
|
Experimental: 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intradialytic symptomatic hypotension
Time Frame: all dialysis sessions, three per week, for 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resistance to erythropoiesis-stimulating agents
Time Frame: Monthly for 2 years
|
Resistance to erythropoiesis-stimulating agents was measured as (EPO therapy in IU/week)/(Hb in g/dL*body wheight in kg)
|
Monthly for 2 years
|
Calcium-phosphate metabolism
Time Frame: Monthly for 2 years
|
Outcome measures: phosphatemia, calcemia and PTH
|
Monthly for 2 years
|
Beta2 microglobulin
Time Frame: Every six months for 2 years
|
Every six months for 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Francesco Locatelli, Professor, A. Manzoni Hospital, Lecco - Italy
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CONVESTUDY
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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