Efficacy Study of CytoSorb Hemoperfusion Device on IL-6 Removal in ARDS/ALI Patients With Sepsis

Sepsis Clinical Trial

Official title: Multi-Center, Efficacy Study of the MedaSorb CytoSorb™ Hemoperfusion Device as an Adjunctive Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS) or Acute Lung Injury (ALI) in the Setting of Sepsis

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sepsis
• Toxemia

• NCT number: NCT00559130
• Study type: Interventional
• Source: MedaSorb Technologies, Inc
• Status: Completed
• Phase: N/A
• Start date: November 2007
• Completion date: June 2011