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Clinical Trials/EUCTR2006-003539-56-AT
EUCTR2006-003539-56-AT
Active, not recruiting
Phase 1

Simvastatin in patients with septic shock

Medical University of Vienna, Department of Internal Medicine IV0 sites40 target enrollmentOctober 24, 2006
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Drugs80 mg Zocord

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Medical University of Vienna, Department of Internal Medicine IV
Enrollment
40
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 24, 2006
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Medical University of Vienna, Department of Internal Medicine IV

Eligibility Criteria

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
  • •\-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

Outcomes

Primary Outcomes

Not specified

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