Simvastatin in Patients With Septic Shock

NCT00450840 | Unknown Phase 4

• 1 other identifier: 3732006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

septic shock; simvastatin

Outcome Measures

Primary Outcomes (1)

• Time to shock reversal as defined by cessation of vasopressor support > 1 hour

Interventions

Simvastatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Dep. of Internal Medicine III

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (1)

• 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.

  PMID: 24794878 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Peter Schenk, MD

  Medical University of Vienna, Intensive Care Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Schenk, MD

CONTACT

0043-1-40400; peter.schenk@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 21, 2007
• First Posted: March 22, 2007
• Last Updated: September 17, 2007

Record last verified: 2007-09

Locations

AU (1)