Statin Therapy in the Treatment of Sepsis

This study has been completed.
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center Identifier:
First received: May 9, 2008
Last updated: September 3, 2015
Last verified: September 2015
Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo

Condition Intervention Phase
Septic Shock
Drug: Simvastatin
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Statin Therapy in the Treatment of Sepsis

Resource links provided by NLM:

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Time to Shock Reversal [ Time Frame: June 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IL- 6 Levels [ Time Frame: June 2008 ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Simvastatin 40 mg PO or NGT
Drug: Simvastatin
Simvastatin 40mg PO or NGT
Other Name: Zocor
Placebo Comparator: 2
Drug: Placebo
Corn Starch


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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
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Please refer to this study by its identifier: NCT00676897

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02446
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael Donnino, Dr. Michael Donnino, Beth Israel Deaconess Medical Center Identifier: NCT00676897     History of Changes
Other Study ID Numbers: 2007P-000257 
Study First Received: May 9, 2008
Last Updated: September 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
statin, sepsis, septic shock, simvastatin

Additional relevant MeSH terms:
Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 26, 2016