S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT
- Conditions
- Severe Sepsis
- Interventions
- Device: S.A.F.E.BT
- Registration Number
- NCT01312675
- Lead Sponsor
- B. Braun Medical Inc.
- Brief Summary
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
Is extracorporeal treatment effective in the treatment of sepsis
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A S.A.F.E.BT S.A.F.E.BT plus Standard of Care therapy
- Primary Outcome Measures
Name Time Method Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) Baseline through Day 8 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States