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Simvastatin in Patients With Septic Shock

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ClinicalTrials.gov Identifier: NCT00450840
Recruitment Status : Unknown
Verified September 2007 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : March 22, 2007
Last Update Posted : September 17, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The beneficial effect of statins to prevent cardiovascular events in patients at risk is well established. Recent trials demonstrated that statins can exert a number of vascular actions independent of lipid lowering. Short-term simvastatin therapy recently has been reported to reduce mortality in 2 different animal models of sepsis. Pleiner and coworkers could demonstrate potent vasoprotective properties of simvastatin during Escherichia coli endotoxin induced endotoxemia in healthy volunteers. In a population-based cohort analysis it was demonstrated that administration of statins was associated with a reduced risk of subsequent sepsis. Thus, simvastatin treatment may offer a new therapeutic strategy for clinical conditions associated with inflammation like severe sepsis and septic shock. The aim of the present study is to test the hypothesis that short term treatment with simvastatin may mitigate the detrimental vascular effects of acute inflammation in patients admitted to the intensive care unit requiring treatment for septic shock.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Simvastatin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
Drug Information available for: Simvastatin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Time to shock reversal as defined by cessation of vasopressor support > 1 hour

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age > 18 years
  • Septic Shock for less than 48 hours

Exclusion Criteria:

  • Pregnancy
  • Unable to receive enteral medications
  • Expected survival of less than 72 hours
  • Treatment in the previous 3 weeks with simvastatin or other HMG-CoA reductase inhibitors
  • History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
  • History of known or suspected porphyria
  • High risk of rhabdomyolysis (multiple trauma, crush injuries, extensive burns, baseline creatinine kinase (CK) ≥ten-times upper limit of normal
  • Hemorrhagic shock
Contacts and Locations

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): NCT00450840


Contacts
Contact: Peter Schenk, MD 0043-1-40400 ext 4767 peter.schenk@meduniwien.ac.at

Locations
Austria
Medical University of Vienna, Dep. of Internal Medicine III Recruiting
Vienna, Austria, 1090
Contact: Valentin Fuhrmann, MD    0043-1-40400 ext 4767    valentin.fuhrmann@meduniwien.ac.at   
Sub-Investigator: Valentin Fuhrmann, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Peter Schenk, MD Medical University of Vienna, Intensive Care Unit
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00450840     History of Changes
Other Study ID Numbers: 3732006
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: September 17, 2007
Last Verified: September 2007

Keywords provided by Medical University of Vienna:
septic shock
simvastatin

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors