NCT01067313|CompletedPhase 2/3
Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane
Evaluation of Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane in Intensive Care
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Evaluation of Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane in Intensive Care
Sponsor study identifier
interventional
24
1 country
1
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
January 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 10, 2010
Actual (reported)February 11, 2010
Actual (reported)July 2010
Actual (reported)January 2011
Actual (reported)Clearance of Urea
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of creatinine
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of total protein
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of albumin
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of Beta 2-microglobulin
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Mean arterial pressure
Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
vasopressor requirement
Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
PaO2 / FiO2
Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Heart rate
Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Lactate level
Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Dialyzer Ultraflux EMiC2 used in Continuous Hemodialysis
Dialyzer Ultraflux AV1000S used in continuous Hemofiltration
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.
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.
Edouard Herriot Hospital, P Reanimation
Lyon, 69003, France
Bernard Allaouchiche, Professor
Hospices Civils de Lyon
24 participants (actual enrollment reported by the registry).
First Submitted
February 10, 2010
First Posted
February 11, 2010
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
The Cooling And Surviving Septic Shock Study (CASS)
Free light chains kappa of Immunoglobulins
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 2010
Actual (reported)Study Completion
January 2011
Actual (reported)Last Updated
March 29, 2011
Record last verified: 2010-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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