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Simvastatin in Patients With Septic Shock

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00450840
First received: March 21, 2007
Last updated: September 14, 2007
Last verified: September 2007

March 21, 2007
September 14, 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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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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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
Both
18 Years and older
No
Contact: Peter Schenk, MD 0043-1-40400 ext 4767 peter.schenk@meduniwien.ac.at
Austria
 
NCT00450840
3732006
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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