Statin Therapy in the Treatment of Sepsis

Phase 3CompletedNCT00676897

Beth Israel Deaconess Medical Center18 enrolled

Overview

Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Septic Shock

Interventions

SimvastatinDRUG

Simvastatin 40mg PO or NGT

PlaceboDRUG

Corn Starch

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Time to Shock Reversal

Time frame: up to 7 days

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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