Simvastatin in patients with septic shock

Phase 1

• Conditions: Septic shock

• Registration Number: EUCTR2006-003539-56-AT
• Lead Sponsor: Medical University of Vienna, Department of Internal Medicine IV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-24
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

-Patients aged more than 18 years
-Presence of septic shock for less than 48 hours

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-hemorrhagic shock
-High risk of rhabdomyolysis (multiple trauma, crush injuries, extensive
burns, baseline creatinine kinase (CK) =ten-times upper limit of normal
(ULN)
-History of known or suspected porphyria
-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
-unable to receive enteral medications
-pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Simvastatin reduces the duration of vasopressor use in patients with septic shock;Secondary Objective: -Disease severity (APACHE III score, organ failure, SOFA-score, ICU and <br> hospital length of stay)<br>-Mortality (ICU mortality, hospital mortality, 28 day mortality)<br>-Inflammatory markers (CRP, White blood count, TNF-a, VEGF, Il-6, <br> Fibrinogen, MDA)<br>-lipid profile<br>;Primary end point(s): Duration of Vasopressor use