Simvastatin in patients with septic shock

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003539-56-AT

Enrollment

Registered

2006-10-24

Start date

2006-11-10

Completion date

Unknown

Last updated

2016-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic shock

Interventions

Trade Name: 80 mg Zocord Product Name: Simvastatin Pharmaceutical Form: Tablet INN or Proposed INN: SIMVASTATIN CAS Number: 79902639 Current Sponsor code: Zocord Other descriptive name: Zocord Concent

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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 hospital length of stay) - Mortality (ICU mortality, hospital mortality, 28 day mortality) - Inflammatory markers (CRP, White blood count, TNF-a, VEGF, Il-6, Fibrinogen, MDA) - lipid profile ;Primary end point(s): Duration of Vasopressor use	—

Measure

Time frame

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 hospital length of stay) - Mortality (ICU mortality, hospital mortality, 28 day mortality) - Inflammatory markers (CRP, White blood count, TNF-a, VEGF, Il-6, Fibrinogen, MDA) - lipid profile ;Primary end point(s): Duration of Vasopressor use

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026