S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT



Status:Terminated
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:10/14/2018
Start Date:April 2011
End Date:June 2015

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Randomized, Multi-Centre, Controlled Clinical Study on Effect of the Selective Adsorption System for Removal of Bacterial Toxins (S.A.F.E.BT) Therapy on Disease Severity and Inflammation in Mechanically-Ventilated Subjects Due to Severe Sepsis

The purpose of this study is to determine if Selective Adsorption System for Removal of
Bacterial Toxins (S.A.F.E.BT) therapy is effective in the treatment of severe sepsis.

Is extracorporeal treatment effective in the treatment of sepsis

Inclusion Criteria

- Clinical diagnosis of Sepsis

- Mechanical ventilation due to acute pulmonary dysfunction

- One additional (second) acute sepsis-related organ dysfunction

Exclusion Criteria

- Pregnant women and nursing mothers

- Conditions or medications associated with an increased risk of bleeding/complications
from anticoagulation

- Previous episode of sepsis during this hospitalization

- PaO2/FiO2 ratio < 300

- Severe granulocytopenia (leukocytes <500 / μl)

- Acute hepatic diseases or severe liver failure or cirrhosis

- Chronic cardiovascular disease precluding extracorporeal treatment

- Human immunodeficiency virus complicated by AIDS defining illness

- Evidence of active bleeding - uncontrolled hemorrhage
We found this trial at
2
sites
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Baltimore, MD
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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