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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
Recruitment status was: Recruiting
Sponsor:
Medical University of Vienna
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00450840
First received: March 21, 2007
Last updated: September 14, 2007
Last verified: September 2007
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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 |
Resource links provided by NLM:
Further study details as provided by Medical University of Vienna:
Eligibility| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450840
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
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 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017