Severe Sepsis
Conditions
Keywords
severe sepsis, mechanical ventilation
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
Interventions
DEVICES.A.F.E.BT
Five (5) S.A.F.E.BT treatments within a 7 day treatment period.
Sponsors
B. Braun Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A S.A.F.E.BT plus Standard of Care therapy
S.A.F.E.BT: Five (5) S.A.F.E.BT treatments within a 7 day treatment period. | 9 |
| Group B Standard of Care therapy alone | 7 |
| Total | 16 |
Baseline characteristics
| Characteristic | Group A | Group B | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 6 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 9 | 1 / 7 |
| other Total, other adverse events | 9 / 9 | 7 / 7 |
| serious Total, serious adverse events | 2 / 9 | 5 / 7 |
Outcome results
Primary
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.
Time frame: Baseline through Day 8
Population: Intent to Treat (ITT)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 6 | 5.6 scores on a scale | Standard Deviation 3.55 |
| Group A | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 3 | 6.1 scores on a scale | Standard Deviation 2.1 |
| Group A | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 4 | 6.6 scores on a scale | Standard Deviation 2.83 |
| Group A | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 5 | 6.9 scores on a scale | Standard Deviation 2.97 |
| Group A | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 7 | 5.1 scores on a scale | Standard Deviation 3.93 |
| Group A | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 8 | 4.3 scores on a scale | Standard Deviation 2.81 |
| Group A | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Screening | 7.4 scores on a scale | Standard Deviation 2.7 |
| Group A | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 1 / Baseline | 6.9 scores on a scale | Standard Deviation 2.57 |
| Group A | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 2 | 6.9 scores on a scale | Standard Deviation 2.09 |
| Group B | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 1 / Baseline | 11.9 scores on a scale | Standard Deviation 2.41 |
| Group B | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 8 | 7.7 scores on a scale | Standard Deviation 1.98 |
| Group B | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 3 | 10.4 scores on a scale | Standard Deviation 3.41 |
| Group B | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 2 | 11.4 scores on a scale | Standard Deviation 3.1 |
| Group B | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 4 | 9.0 scores on a scale | Standard Deviation 3.61 |
| Group B | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Screening | 11.9 scores on a scale | Standard Deviation 3.24 |
| Group B | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 6 | 7.1 scores on a scale | Standard Deviation 2.85 |
| Group B | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 5 | 7.0 scores on a scale | Standard Deviation 4.08 |
| Group B | Sequential Organ Failure Assessment (SOFA) Score (a.k.a. Sepsis-related Organ Failure Assessment) | Day 7 | 8.1 scores on a scale | Standard Deviation 2.91 |