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Statin Therapy in the Treatment of Sepsis

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.
 
ClinicalTrials.gov Identifier: NCT00676897
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Simvastatin Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Statin Therapy in the Treatment of Sepsis
Study Start Date : February 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Simvastatin 40 mg PO or NGT
 Drug: Simvastatin
Simvastatin 40mg PO or NGT
Other Name: Zocor
Placebo Comparator: 2
Placebo
 Drug: Placebo
Corn Starch


Outcome Measures
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Primary Outcome Measures :
  1. Time to Shock Reversal [ Time Frame: up to 7 days ]

Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676897


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02446
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Michael Donnino, Dr. Michael Donnino, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00676897    
Other Study ID Numbers: 2007P000257
First Posted: May 13, 2008    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Keywords provided by Michael Donnino, Beth Israel Deaconess Medical Center:
statin, sepsis, septic shock, simvastatin
Additional relevant MeSH terms:
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Simvastatin
Sepsis
Shock, Septic
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors