Simvastatin in Patients With Septic Shock

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
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
  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:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

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
Shock, Septic
Infection
Inflammation
Pathologic Processes
Sepsis
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 October 22, 2014