Simvastatin in Patients With Septic Shock - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00450840

Purpose

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	Intervention	Phase
Septic Shock	Drug: Simvastatin	Phase IV

MedlinePlus related topics: Sepsis Statins

Drug Information available for: Simvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	3732006
Study First Received:	March 21, 2007
Last Updated:	September 14, 2007
ClinicalTrials.gov Identifier:	NCT00450840
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:

septic shock
simvastatin

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Shock

Simvastatin
Shock, Septic
Inflammation

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009