Statins in Sepsis Study

Phase 2

Completed

• Conditions: Severe Sepsis; Blood - Other blood disorders

• Registration Number: ACTRN12607000028404
• Lead Sponsor: Australia New Zealand Intensive Care Research Centre, a centre of Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

All patients admitted to the intensive care unit with severe sepsis of less than 24 hours duration. Patients must have 3 or more features of systemic inflammatory response syndrome, a strongly suspected or confirmed site of sepsis, presence of organ dysfunction in at least one of the 5 following categories: (cardiovascular system , renal, respiratory, haematologic, unexplained metabolic acidosis).

Exclusion Criteria

Death is imminent, pregnancy or breastfeeding, known history of intolerance to a statin agent, acute liver failure (INR[International Normalised Ratio] greater than 2.5), Child's C classification of liver disease ( a grade of C as measured on the Child-Pugh Classification of Liver Disease, ie very severe liver disease), ALT (alanine transaminase ) > 5 x ULN (Upper Limit of Normal), CK (creatinine kinase) > 5x ULN (Upper Limit of Normal), patient unable to take enteral medication, patient or next of kin/person responsible unable to provide informed consent, patient, family or physician not in favor of aggressive treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in serum interleukin-6 level, a marker of inflammation[Measured at day 0,1, 3, 5, 10, 14 and 48 hours post last dose]

Secondary Outcome Measures

Name	Time	Method
evels of biological markers of oxidative stress, inflammation, lipid profiles[Measured at day 0,1,3,5,10,14 and 48 hours post last dose.];Adverse event frequency[Measured continuously throughout studyfor a maximum of 30 days.];Length of stay in intensive care unit[Recorded at 28 days];Hospital mortality[Recorded at 28 days.]