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

Study Overview
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Brief Summary
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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.

Detailed Description
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Is extracorporeal treatment effective in the treatment of sepsis

Official Title
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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

Conditions
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Severe Sepsis

Intervention / Treatment
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* Device: S.A.F.E.BT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>S.A.F.E.BT plus Standard of Care therapy | Device: S.A.F.E.BT<br>* Five (5) S.A.F.E.BT treatments within a 7 day treatment period.<br>|
| No Intervention: Group B<br>Standard of Care therapy alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | The primary outcome measure is the average of all changes in daily SOFA scores from baseline through Day 8. The SOFA score indicates quantitatively, and as objectively as possible, the degree of organ dysfunction/failure by describing a sequence of complications in the critically ill. SOFA score consists of classifications for six (6) organ functions: Respiratory, Cardiovascular, Coagulation, CNS, Liver, and Renal. Each function is assigned a value from 0 (normal organ function) to 4 (most abnormal organ function). Each subject's 6 organ function SOFA scores are summed to become a single daily SOFA score (total score range: 0-24, where 24 is the maximum score associated with the most abnormal function and worst outcomes). A higher SOFA score on Day 2 compared to Day 1 indicates more abnormal organ functions and a worsening physical condition. | Baseline through Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe sepsis, mechanical ventilation