Simvastatin in Patients With Septic Shock

Septic Shock Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00450840
• Other study ID #: 3732006
• Status: Recruiting
• Phase: Phase 4
• First received: March 21, 2007
• Last updated: September 14, 2007

Study information

• Verified date: September 2007
• Source: Medical University of Vienna
• Contact: Peter Schenk, MD
• Phone: 0043-1-40400
• Email: peter.schenk[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Simvastatin

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Dep. of Internal Medicine III	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to shock reversal as defined by cessation of vasopressor support > 1 hour