Statin Therapy in the Treatment of Sepsis

Phase 2

Completed

• Conditions: Septic Shock
• Interventions: Drug: Simvastatin; Drug: Placebo

• Registration Number: NCT00676897
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-05-09
• Study First Submitted QC: 2008-05-09
• Study First Posted: 2008-05-13
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2017-03-10
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-15
• Last Update Submitted: 2017-05-15
• Results First Posted: 2017-06-14
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Simvastatin	Simvastatin 40 mg PO or NGT
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Time to Shock Reversal	up to 7 days

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States