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The Effects of a Polyethyleneimine-coated Membrane (oXiris™) for Hemofiltration Versus Polymyxin B- Immobilized Fibre Column (Toraymyxin™) for Hemoperfusion on Endotoxin Activity and Inflammatory Conditions in Septic Shock- A Randomized Controlled Pilot Study (ENDoX-study)

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ClinicalTrials.gov Identifier: NCT01948778
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

Septic shock has a high mortality risk despite the availability of various treatments. Endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger of innate immunity. Endotoxin leads to an activation of a cascade with an overwhelming systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with generalized vascular endothelial damage, tissue injury and multi-organ failure.

Extracorporeal blood purification therapies aim to reduce the circulating level of endotoxin. Different extracorporeal blood purification systems are available. The oXiris™ device comprises a surface treated AN69 membrane capable to adsorb a large spectrum of plasma cytokines, such as IL-6 and HMGB1 protein. The positively charged inner surface of the membrane allows absorbing negatively charged bacterial products such as endotoxin. From an historical perspective, filters containing AN69-based membranes have been the most commonly used products for CRRT in the management of critically ill patients and a substantial volume of published data exist.

Another extracorporeal endotoxin removal therapy is the hemoperfusion with ToraymyxinTM (PMX) filter, which is a cartridge selectively removing blood endotoxin. PMX is composed of polymyxin B covalently bonded to polystyrene-derivative fibres. It is well known that the polarity of the polymyxin B antibiotic binds endotoxin and has bactericidal activity. Therefore, the rationale underlying extracorporeal therapy with PMX is to remove circulating endotoxin by adsorption.

  • Trial with medical device

Condition or disease Intervention/treatment Phase
Patients in Septic Shock Device: oXiris™ filter Device: Toraymyxin Filter Device: Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of a Polyethyleneimine-coated Membrane (oXiris™) for Hemofiltration Versus Polymyxin B- Immobilized Fibre Column (Toraymyxin™) for Hemoperfusion on Endotoxin Activity and Inflammatory Conditions in Septic Shock- A Randomized Controlled Pilot Study
Study Start Date : August 2013
Actual Primary Completion Date : May 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber Shock

Arm Intervention/treatment
Experimental: oXiris™ filter
oXiris™ filter
Device: oXiris™ filter
Experimental: Toraymyxin Filter
Toraymyxin Filter
Device: Toraymyxin Filter
Standard of Care
Standard of Care CRRT if necessary
Device: Standard of Care



Primary Outcome Measures :
  1. Measurement of the endotoxin activity 72 hours after treatment initiation [ Time Frame: 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria: • Patients with septic shock, defined as 30ml/kg of i.v. fluid administered within a period of 6 hours after initiation of vasopressor therapy with a vasopressor index =3, and at least one of the following criteria: metabolic acidosis, neurologic dysfunction, renal dysfunction, or acute hepatic dysfunction

  • Male and Female patients =18 years
  • Endotoxin levels =0.6 IU EAA (measured at ICU admission and repeated 24 hours later in case the initial value is =0.4 and <0.6)

Exclusion criteria: • Endotoxin levels <0.6 IU EAA

  • Pregnancy or breast feeding
  • Neutropenia (circulating neutrophils <500/µl)
  • Pre-existing immune deficiencies or immune-suppressive therapy, especially corticosteroids
  • Use of Vasopressin (Pitressin?)
  • Organ transplantation within the last 12 months
  • Terminally ill patients classified as "do not resuscitate"
  • History of sensitivity to polymyxin B or to anticoagulant (heparin) HIT or allergy to heparin
  • Need for extracorporeal membrane oxygenation (ECMO)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948778


Locations
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Switzerland
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Marco Maggiorini, Prof MD University Hospital Zurich, University Hospital Zurich, Medical intensive care unit
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01948778    
Other Study ID Numbers: ENDoX_CH012
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation