Status:
COMPLETED
Cytokine Adsorption in Severe, Refractory Septic Shock
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
CytoSorbents Europe GmbH
Conditions:
Septic Shock
Cytokine Storm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Septic shock and the underlying dysregulated inflammatory host-response remain a major contributor to mortality in critically ill patients. Cytokine adsorption represents an attractive approach to the...
Detailed Description
Cytokine-release plays an important role in the physiology of immune response to pathologic influences by recruiting immune cells to the pathogenic loci, be they of infectious or of non-infectious nat...
Eligibility Criteria
Inclusion
- Patients diagnosed septic shock in the 24 hours ensuing diagnosis:
- (I) severe, refractory septic shock defined as:
- an acute SOFA score increase ≥2 points consequent to a presumed or proven infection
- volume resuscitation of at least 30ml/kg in the last 24 hours
- a Vasopressor Dependency Index11 (VPI) above or equal to 3
- a persistently elevated serum lactate level \>2mmol/l (II) Interleukin-6 levels equal or above 1000 ng/l (III) were above 18 years of age.
Exclusion
- Contraindication on ethical grounds
- child bearing or breastfeeding women
- terminal patients
- human immunodeficiency virus with a CD4 cell count \<0.2 106/l
- allergy to Polystyrene/ Divinylbenzene, Polycarbonate, Polypropylene, Silicon or Polyester
- need for extra-corporeal membrane oxygenation
- no given consent.
Key Trial Info
Start Date :
November 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04910893
Start Date
November 27 2014
End Date
December 31 2018
Last Update
June 10 2021
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