Simvastatin in Patients With Septic Shock
Recruitment status was Recruiting
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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-Blind Primary Purpose: Treatment |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00450840
| Contact: Peter Schenk, MD | 0043-1-40400 ext 4767 | peter.schenk@meduniwien.ac.at |
| 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 | |
| Principal Investigator: | Peter Schenk, MD | Medical University of Vienna, Intensive Care Unit |
More Information
No publications provided by Medical University of Vienna
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00450840 History of Changes |
| Other Study ID Numbers: | 3732006 |
| Study First Received: | March 21, 2007 |
| Last Updated: | September 14, 2007 |
| Health Authority: | Austria: Agency for Health and Food Safety |
Keywords provided by Medical University of Vienna:
|
septic shock simvastatin |
Additional relevant MeSH terms:
|
Shock, Septic Infection Inflammation Pathologic Processes Sepsis Shock Systemic Inflammatory Response Syndrome Simvastatin Anticholesteremic Agents |
Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015