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Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane

This study has been completed.
Sponsor:
Collaborator:
Hospices Civils de Lyon
Information provided by:
Fresenius Medical Care France
ClinicalTrials.gov Identifier:
NCT01067313
First received: February 10, 2010
Last updated: March 28, 2011
Last verified: February 2010

February 10, 2010
March 28, 2011
July 2008
July 2010   (final data collection date for primary outcome measure)
  • Clearance of Urea [ Time Frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
  • Clearance of creatinine [ Time Frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
  • Clearance of total protein [ Time Frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
  • Clearance of albumin [ Time Frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
  • Clearance of Beta 2-microglobulin [ Time Frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
  • Free light chains kappa of Immunoglobulins [ Time Frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01067313 on ClinicalTrials.gov Archive Site
  • Mean arterial pressure [ Time Frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
  • vasopressor requirement [ Time Frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
  • PaO2 / FiO2 [ Time Frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
  • Heart rate [ Time Frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
  • Lactate level [ Time Frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane
Evaluation of Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane in Intensive Care

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.

In sepsis, the removal of middle molecular weight molecules such as cytokines (also called blood purification), has shown a great interest in intensive care during the last decades. Indeed, these cytokines are involved in the development of the multi-organ failure syndrome when patients are in septic shock. There is some evidence to suggest that extracorporeal therapies (hemofiltration-hemodialysis)are interesting tools to modulate the inflammatory response and to restore the immune homeostasis.

However, hemodialysis using "conventional" membranes does not allow the removal of middle molecules. Conversely, high-volume hemofiltration is an appropriate therapy but it has a lot of drawbacks due to the high ultrafiltration rates (removal of beneficial small molecules, technical and economical issues due to the use of large amounts of fluid replacement). Finally, high cut-off hemofiltration has been reported to be associated with significant albumin loss.

Therefore, continuous "enhanced middle molecule clearance" hemodialysis could be an interesting alternative, making possible the removal of these middle molecules without significant albumin loss and with some theoretical advantages (reduced cost due to the possibility to produce the dialysate from a water circuit, decreased nursing workload).

The aim of this study is to assess the clearances of different kind of molecules (small, middle and large) when continuous enhanced middle molecule clearance hemodialysis is applied to septic patients.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Septic Shock
  • 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.
  • Experimental: Dialyzer Ultraflux EMiC2
    Dialyzer Ultraflux EMiC2 used in Continuous Hemodialysis
    Intervention: Device: Dialyzer Ultraflux EMiC2
  • Active Comparator: Dialyzer Ultraflux AV1000S
    Dialyzer Ultraflux AV1000S used in continuous Hemofiltration
    Intervention: Device: Dialyzer Ultraflux AV1000S
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
January 2011
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female aged over 18 years.
  • ICU patients with septic shock and AKI requiring continuous renal replacement.
  • Patient able to agree to be enrolled in the study with informed consent. If the patient can not provide consent, only the consent of family members will be sought if they are present and, to default, the opinion of trustworthy person under article L.1111-6 of the French Health Code. If there is no family present, or trustworthy person designated, the subject will not be included in the study.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Participation in another research protocol.
  • People particularly vulnerable as defined in Articles L.1121-5, L.1121-6, L.1121-7, L.1121-8 et L.1122-1-2 of the French Health Code.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01067313
HD-RE-01-F
No
Professor Bernard Allaouchiche, Edouard Herriot Hospital, Lyon, France
Fresenius Medical Care France
Hospices Civils de Lyon
Principal Investigator: Bernard Allaouchiche, Professor Lyon University Hospital
Fresenius Medical Care France
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP