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

B. Braun

Status: Terminated

Conditions: Severe Sepsis

Treatments: Device: S.A.F.E.BT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01312675

BA-I-H-0903

Details and patient eligibility

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.

Full description

Is extracorporeal treatment effective in the treatment of sepsis

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group A

Experimental group

Description:

S.A.F.E.BT plus Standard of Care therapy

Treatment:

Device: S.A.F.E.BT

Group B

No Intervention group

Description:

Standard of Care therapy alone