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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
Information provided by:
Medical University of Vienna

March 21, 2007
March 22, 2007
September 17, 2007
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Time to shock reversal as defined by cessation of vasopressor support > 1 hour
Same as current
Complete list of historical versions of study NCT00450840 on ClinicalTrials.gov Archive Site
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Simvastatin in Patients With Septic Shock
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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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Septic Shock
Drug: Simvastatin
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Dobesh PP, Olsen KM. Statins role in the prevention and treatment of sepsis. Pharmacol Res. 2014 Oct;88:31-40. doi: 10.1016/j.phrs.2014.04.010. Epub 2014 May 2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Medical University of Vienna
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Principal Investigator: Peter Schenk, MD Medical University of Vienna, Intensive Care Unit
Medical University of Vienna
September 2007

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