Efficacy Study of CytoSorb Hemoperfusion Device on IL-6 Removal in ARDS/ALI Patients With Sepsis
Condition: Acute Respiratory Distress Syndrome; Acute Lung Injury; Sepsis
MeSH terms: Sepsis; Toxemia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury; Syndrome
Study type: Interventional

Summary: 
      The hypothesis of this study is use of CytoSorb hemoperfusion device as an adjunctive therapy
      to the standard of care in treating ARDS/ALI patients in the setting of sepsis will result in
      improved clearance of cytokines when compared to control patients receiving only the standard
      of care.
    

Detailed description: 
      Mortality rates from acute lung injury (ALI) and acute respiratory distress syndrome (ARDS)
      range from 38.5 to 65%, with the lower mortality in acute lung injury than in ARDS.

      ARDS/ALI is most often seen as part of a systemic inflammatory response syndrome (SIRS),
      particularly systemic sepsis. The lung findings parallel the damage in other tissues, namely,
      widespread destruction of the capillary endothelium, extravasation of protein rich fluid and
      interstitial edema. The alveolar basement membrane becomes damaged and fluid leaks into the
      airspaces, reducing lung compliance and causing ventilation-perfusion mismatch.

      The most important causes of ALI/ARDS are sepsis, pneumonia, major trauma, pulmonary
      aspiration, near drowning, burns, inhalation of toxic gases (e.g. ammonia), fat embolism,
      amniotic fluid embolism, eclampsia, drug intoxication (e.g. aspirin), radiation injury and
      mechanical ventilation. Cox and colleagues have demonstrated in an ovine model of ARDS that
      there is intense acute inflammation in the trachea and bronchi from 3 to 48h after injury,
      with accumulation of neutrophils, fibrin and other plasma proteins, and mucus in airway
      lumens. Immunostaining for multiple cytokines (interleukin-8 (IL-8), IL-1beta, IL-1alpha,
      tumor necrosis factor-alpha (TNF-alpha), and vascular endothelial growth factor (VEGF)) are
      found in airway mucous glands, and the release of cytokines into the airway lumen are
      considered potentially highly significant in the progression of injury.

      The importance of cytokines is being increasingly realized in mechanical lung injury (a
      common cause of ALI/ARDS) associated with mechanical ventilation (MV). Here the pathway is
      identical with release of cytokines/chemokines which potentiate the extravasation,
      activation, and recruitment of leukocytes, causing ventilator-associated lung injury (VALI)
      and ventilator-induced lung injury (VILI). Moreover, VALI/VILI can perpetuate the chronic
      inflammatory response during ALI/ARDS and multiple organ dysfunction syndrome (MODS).

      The purpose of this study is to evaluate the reduction of cytokines, using the CytoSorb
      device, on primary and secondary endpoints
    

Intervention name(s): CytoSorb Hemoperfusion
Intervention type(s): Device
Intervention description(s): Daily hemoperfusion for 6 hours with CytoSorb device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Respiratory Distress Syndrome; Acute Lung Injury; Sepsis; Hemoperfusion