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NCT00676897 Clinical Trial

Statin Therapy in the Treatment of Sepsis

Septic Shock Clinical Trial

Official title:
Study of Statin Therapy in the Treatment of Sepsis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00676897
Other study ID # 2007P-000257
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received May 9, 2008
Last updated September 3, 2015
Start date February 2008
Est. completion date December 2010

Study information
Verified date September 2015
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Simvastatin
Simvastatin 40mg PO or NGT
• Placebo
Corn Starch

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to Shock Reversal June 2009 No
Secondary IL- 6 Levels June 2008 No
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