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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Septic Shock
 Device: Dialyzer Ultraflux EMiC2
Device: Dialyzer Ultraflux AV1000S
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Evaluation of Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane in Intensive Care

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Shock
U.S. FDA Resources

Further study details as provided by Fresenius Medical Care France:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: July 2008
Study Completion Date: January 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dialyzer Ultraflux EMiC2
Dialyzer Ultraflux EMiC2 used in Continuous Hemodialysis
 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.
Active Comparator: Dialyzer Ultraflux AV1000S
Dialyzer Ultraflux AV1000S used in continuous Hemofiltration
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067313

Locations
France
Edouard Herriot Hospital, P Reanimation
Lyon, France, 69003
Sponsors and Collaborators
Fresenius Medical Care France
Hospices Civils de Lyon
Investigators
Principal Investigator: Bernard Allaouchiche, Professor Lyon University Hospital
  More Information

No publications provided

Responsible Party: Professor Bernard Allaouchiche, Edouard Herriot Hospital, Lyon, France
ClinicalTrials.gov Identifier: NCT01067313     History of Changes
Other Study ID Numbers: HD-RE-01-F
Study First Received: February 10, 2010
Last Updated: March 28, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Fresenius Medical Care France:
Intensive Care Unit
continuous hemodialysis
continuous hemofiltration
High Cut-off membrane
"Enhanced middle molecule clearance" membrane
 Septic shock
Acute kidney injury
Blood purification
Renal replacement therapy

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
 Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on May 16, 2013