Septic Shock
Conditions
Keywords
statin, sepsis, septic shock, simvastatin
Brief summary
Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo
Interventions
DRUGSimvastatin
Simvastatin 40mg PO or NGT
DRUGPlacebo
Corn Starch
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than 18 years old * Hypotensive requiring vasopressors * Suspected Infection
Exclusion criteria
* Pregnant * Liver Failure (ALT or AST \> 120) * Rhabomyolysis (CPK \> 3x normal) * Comfort care measures status * Chronic Liver Disease (Cirrhosis) * Use of Cyclosporin, Digoxin, Statins * Patients who are unable to take medications by mouth or NGT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Shock Reversal | up to 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Marker Levels | over 24 hours (time zero and time 24 hours) | Change in inflammatory marker levels over time from time zero to time 24 hour. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Statin Group Simvastatin: Simvastatin 40mg PO or NGT | 8 |
| Placebo Group Placebo: Corn Starch | 10 |
| Total | 18 |
Baseline characteristics
| Characteristic | Statin Group | Total | Placebo Group |
|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 18 | 58.72 years STANDARD_DEVIATION 17.19 | 54 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 18 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 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 | 4 Participants | 3 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 | 7 Participants | 14 Participants | 7 Participants |
| Region of Enrollment United States | 8 participants | 18 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 10 |
| serious Total, serious adverse events | 0 / 8 | 0 / 10 |
Outcome results
Primary
Time to Shock Reversal
Time frame: up to 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Statin Group | Time to Shock Reversal | 44.4 hours | Standard Deviation 57.3 |
| Placebo Group | Time to Shock Reversal | 28.6 hours | Standard Deviation 34.5 |
Secondary
Inflammatory Marker Levels
Change in inflammatory marker levels over time from time zero to time 24 hour.
Time frame: over 24 hours (time zero and time 24 hours)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Statin Group | Inflammatory Marker Levels | TNF-alpha (pg/mL) | -0.52 pg/mL and ng/mL | Standard Deviation 26 |
| Statin Group | Inflammatory Marker Levels | VEGF (pg/mL) | -98 pg/mL and ng/mL | Standard Deviation 306 |
| Statin Group | Inflammatory Marker Levels | IL-6 (pg/mL) | -370 pg/mL and ng/mL | Standard Deviation 698 |
| Statin Group | Inflammatory Marker Levels | ICAM (ng/mL) | 148 pg/mL and ng/mL | Standard Deviation 282 |
| Statin Group | Inflammatory Marker Levels | VCAM (ng/mL) | 1279 pg/mL and ng/mL | Standard Deviation 2275 |
| Statin Group | Inflammatory Marker Levels | eSelectin (ng/mL) | 98 pg/mL and ng/mL | Standard Deviation 202 |
| Placebo Group | Inflammatory Marker Levels | VCAM (ng/mL) | 190 pg/mL and ng/mL | Standard Deviation 1049 |
| Placebo Group | Inflammatory Marker Levels | ICAM (ng/mL) | -0.10 pg/mL and ng/mL | Standard Deviation 69 |
| Placebo Group | Inflammatory Marker Levels | VEGF (pg/mL) | 269 pg/mL and ng/mL | Standard Deviation 396 |
| Placebo Group | Inflammatory Marker Levels | eSelectin (ng/mL) | 11 pg/mL and ng/mL | Standard Deviation 29 |
| Placebo Group | Inflammatory Marker Levels | IL-6 (pg/mL) | -423 pg/mL and ng/mL | Standard Deviation 620 |
| Placebo Group | Inflammatory Marker Levels | TNF-alpha (pg/mL) | -2.17 pg/mL and ng/mL | Standard Deviation 43 |