Effects of Convective Therapies in Dialysis Patients (ECTDP)

April 23, 2012 updated by: Prof. Francesco Locatelli, A. Manzoni Hospital

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

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • Cagliari, Italy
        • S. Michele Hospital
      • La maddalena, Italy
        • Ospedale Civile "P. Merlo"
      • Lecco, Italy
        • Alessandro Manzoni Hospital
      • Mantova, Italy
        • Ospedale "C. POMA"
      • 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
      • Ozieri, Italy
        • Ospedale Antonio Segni
      • Parma, Italy
        • Ospedale Maggiore
      • Pavia, Italy
        • Fondazione Maugeri
      • Pinerolo, Italy
        • Ospedale " E. AGNELLI "
      • Quartu Sant'Elena, Italy
        • Dipartimento territoriale ASL 8
      • Ravenna, Italy
        • Ospedale S.Maria delle Croci
      • Reggio Calabria, Italy
        • Azienda Ospedaliera "Bianchi Melacrino Morelli,"
      • Seriate, Italy
        • Ospedale Bolognini
      • Solofra, Italy
        • Ospedale Agostino Landolfi
      • Sorgono, Italy
        • Ospedale San Camillo
      • Tempio Pausania, Italy
        • ASL 2 Olbia - P.O. "P. Dettori",

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • online pre-dilution hemofiltration Technique
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:
  • online pre-dilution hemodiafiltration Technique

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Francesco Locatelli, Professor, A. Manzoni Hospital, Lecco - Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

April 17, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Estimate)

April 24, 2012

Last Update Submitted That Met QC Criteria

April 23, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

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.

Clinical Trials on Uremia

Clinical Trials on online pre-dilution hemofiltration

3
Subscribe