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Severe Sepsis

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

Sponsored by B. Braun Medical Inc.

About this trial

Last updated 7 years ago

Study ID

BA-I-H-0903

Status

Terminated

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 10 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- Clinical diagnosis of Sepsis

- Mechanical ventilation due to acute pulmonary dysfunction

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

No

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