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Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane

NCT01067313 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-03-29

No results posted yet for this study

Summary

This study aims to demonstrate equivalence in terms of molecule removal between continuous hemodialysis using an "enhanced middle molecule clearance" membrane(Ultraflux EMiC2) and continuous hemofiltration using a standard membrane (Ultraflux AV1000S) in ICU patients requiring continuous renal replacement therapy.

Conditions

  • Septic Shock

Interventions

DEVICE

Dialyzer Ultraflux EMiC2

Dialysate flow rate = 40 ml/kg/h The treatment duration may be variable depending on modifications in patient health status, but will not exceed 3 sessions of 48 hours each.

DEVICE

Dialyzer Ultraflux AV1000S

Ultrafiltration flow rate = 40 ml/kg/h The blood flow rate will be adjusted to obtain a filtration fraction of 20%. Reinjection = 100% postdilution. The treatment duration may be variable depending on modifications in patient health status, but will not exceed 3 sessions of 48 hours each.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    collaborator OTHER

  • Fresenius Medical Care France

    lead INDUSTRY

Principal Investigators

  • Bernard Allaouchiche, Professor · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-07-31
Completion
2011-01-31

Countries

  • France

Study Locations

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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 NCT01067313 on ClinicalTrials.gov