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

Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment)

时间窗: 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.