Statin Therapy in the Treatment of Sepsis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Beth Israel Deaconess Medical Center
Sponsor:
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00676897
First received: May 9, 2008
Last updated: October 8, 2013
Last verified: October 2013

May 9, 2008
October 8, 2013
February 2008
December 2013   (final data collection date for primary outcome measure)
Time to Shock Reversal [ Time Frame: June 2009 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00676897 on ClinicalTrials.gov Archive Site
IL- 6 Levels [ Time Frame: June 2008 ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2013
December 2013   (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
Both
18 Years and older
No
United States
 
NCT00676897
2007P-000257
Yes
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
October 2013

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