Effects of Convective Therapies in Dialysis Patients (ECTDP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Francesco Locatelli, A. Manzoni Hospital
ClinicalTrials.gov Identifier:
NCT01583309
First received: April 17, 2012
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Uremia
Procedure: online pre-dilution hemofiltration
Procedure: online pre-dilution hemodiafiltration
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Convective Therapies in Dialysis Patients

Resource links provided by NLM:


Further study details as provided by A. Manzoni Hospital:

Primary Outcome Measures:
  • Intradialytic symptomatic hypotension [ Time Frame: all dialysis sessions, three per week, for 2 years ] [ Designated as safety issue: No ]
    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:
  • Resistance to erythropoiesis-stimulating agents [ Time Frame: Monthly for 2 years ] [ Designated as safety issue: No ]
    Resistance to erythropoiesis-stimulating agents was measured as (EPO therapy in IU/week)/(Hb in g/dL*body wheight in kg)

  • Calcium-phosphate metabolism [ Time Frame: Monthly for 2 years ] [ Designated as safety issue: No ]
    Outcome measures: phosphatemia, calcemia and PTH

  • Beta2 microglobulin [ Time Frame: Every six months for 2 years ] [ Designated as safety issue: No ]

Enrollment: 146
Study Start Date: November 2003
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01583309

Locations
Italy
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 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
Investigators
Study Chair: Francesco Locatelli, Professor A. Manzoni Hospital, Lecco - Italy
  More Information

Publications:
Responsible Party: Prof. Francesco Locatelli, Professor Francesco Locatelli, A. Manzoni Hospital
ClinicalTrials.gov Identifier: NCT01583309     History of Changes
Other Study ID Numbers: CONVESTUDY
Study First Received: April 17, 2012
Last Updated: April 23, 2012
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Uremia
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014