Phase 3
N=18
Statin Therapy in the Treatment of Sepsis
Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT00676897 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Time to Shock Reversal — 44.4; 28.6 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Simvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Shock Reversal |
44.4; 28.6 | — |
| SECONDARY Inflammatory Marker Levels |
-98; 269; -370; -423; -0.52; -2.17 | — |
Summary
Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00676897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.