Mid-HDF Randomized Controlled Study on Outcome

NCT01693354 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2017-01-13

No results posted yet for this study

Summary

The purpose of this study is to determine whether mid-dilution hemodiafiltration is effective in the reduction of the crude mortality risk in patients who have been undergoing renal replacement treatment for less than 1 year. Patients will be randomized since the beginning of the study in two groups: standard HF dialysis and mid-dilution HDF.

Conditions

Interventions

DEVICE

Mid-dilution HDF

Mid-dilution HDF is a special, newly developed variant of online HDF which is characterized by a dedicated high-flux hemodialyzer named OLPUR MD able to support simultaneous pre- and post-dilution

DEVICE

HF dialysis

Standard hemodialyzers equipped with high permeability polyphenylene/polyethersulfone membranes

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Francisco Maduell, MD · Hospital Clínic Barcelona, Spain

  • Vincenzo Panichi, MD, PhD · AUSL 12 Viareggio, Italy

  • Pedro Aljama, MD, PhD · Hospital Reina Sofia, Cordoba, Spain

  • Michel Jadoul, MD, PhD · Cliniques Universitaires Saint-Luc, Brussels, Belgium

  • Philippe Brunet, MD, PhD · Hôpital de la Conception, Marseille, France

  • Antonio Santoro, MD · AOSP Bologna, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-09-30
Completion
2018-09-30

Countries

  • Belgium
  • France
  • Italy
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01693354 on ClinicalTrials.gov