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Simvastatin in Patients With Septic Shock

NCT ID: NCT00450840

Last Updated: 2007-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Simvastatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Principal Investigators

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Peter Schenk, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Intensive Care Unit

Locations

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Medical University of Vienna, Dep. of Internal Medicine III

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Peter Schenk, MD

Role: CONTACT

[email protected]
0043-1-40400 ext. 4767

Facility Contacts

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Valentin Fuhrmann, MD

Role: primary

[email protected]
0043-1-40400 ext. 4767

References

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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.

Reference Type DERIVED
PMID: 24794878 (View on PubMed)

Other Identifiers

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3732006

Identifier Type: -

Identifier Source: org_study_id