Simvastatin in Patients With Septic Shock

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2007 by Medical University of Vienna.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00450840

First Posted: March 22, 2007

Last Update Posted: September 17, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Medical University of Vienna

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Shock

Drug Information available for: Simvastatin

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00450840 History of Changes
Other Study ID Numbers:	3732006
First Submitted:	March 21, 2007
First Posted:	March 22, 2007
Last Update Posted:	September 17, 2007
Last Verified:	September 2007

Keywords provided by Medical University of Vienna:


septic shock simvastatin

Additional relevant MeSH terms:


Shock Shock, Septic Pathologic Processes Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Simvastatin	Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

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