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Effects of Convective Therapies in Dialysis Patients (ECTDP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583309
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : April 24, 2012
Information provided by (Responsible Party):
Prof. Francesco Locatelli, A. Manzoni Hospital

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.

Condition or disease Intervention/treatment Phase
Uremia Procedure: online pre-dilution hemofiltration Procedure: online pre-dilution hemodiafiltration Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Convective Therapies in Dialysis Patients
Study Start Date : November 2003
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: low-flux hemodialysis
Experimental: online pre-dilution hemofiltration Procedure: 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 Name: online pre-dilution hemofiltration Technique

Experimental: online pre-dilution hemodiafiltration Procedure: 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 Name: online pre-dilution hemodiafiltration Technique

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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)

  2. Calcium-phosphate metabolism [ Time Frame: Monthly for 2 years ]
    Outcome measures: phosphatemia, calcemia and PTH

  3. Beta2 microglobulin [ Time Frame: Every six months for 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583309

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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
Melito Porto Salvo, Italy
Ospedale dell'Angelo
Mestre, Italy
Policlinico Multimedica IRCCS
Milano, 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
Sponsors and Collaborators
A. Manzoni Hospital
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Study Chair: Francesco Locatelli, Professor A. Manzoni Hospital, Lecco - Italy

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Francesco Locatelli, Professor Francesco Locatelli, A. Manzoni Hospital Identifier: NCT01583309     History of Changes
Other Study ID Numbers: CONVESTUDY
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012

Keywords provided by Prof. Francesco Locatelli, A. Manzoni Hospital:
blood pressure
cardiovascular instability
symptomatic hypotension
online hemofiltration
online hemodiafiltration

Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases