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Statin Therapy in the Treatment of Sepsis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676897
First Posted: May 13, 2008
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center
May 9, 2008
May 13, 2008
March 10, 2017
June 14, 2017
June 14, 2017
February 2008
December 2010   (Final data collection date for primary outcome measure)
Time to Shock Reversal [ Time Frame: up to 7 days ]
Time to Shock Reversal [ Time Frame: June 2009 ]
Complete list of historical versions of study NCT00676897 on ClinicalTrials.gov Archive Site
Inflammatory Marker Levels [ Time Frame: over 24 hours (time zero and time 24 hours) ]
Change in inflammatory marker levels over time from time zero to time 24 hour.
IL- 6 Levels [ Time Frame: June 2008 ]
Not Provided
Not Provided
 
Statin Therapy in the Treatment of Sepsis
Study of Statin Therapy in the Treatment of Sepsis
Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Septic Shock
  • Drug: Simvastatin
    Simvastatin 40mg PO or NGT
    Other Name: Zocor
  • Drug: Placebo
    Corn Starch
  • Experimental: 1
    Simvastatin 40 mg PO or NGT
    Intervention: Drug: Simvastatin
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00676897
2007P000257
Yes
Not Provided
Not Provided
Michael Donnino, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Not Provided
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP