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

Stopped early · Not applicable

Conditions studied: Severe Sepsis

In brief

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.

Key facts

Study ID

NCT01312675

Run by

B. Braun Medical Inc.

People needed

16

Starts

2011-04-01

Expected to finish

2015-06-01

Last updated by the study team

2018-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of Sepsis
• Mechanical ventilation due to acute pulmonary dysfunction
• One additional (second) acute sepsis-related organ dysfunction

You may not qualify if…

• 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

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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