None listed
Conditions
Brief summary
15,000 people are admitted to an Intensive Care Unit in Australia with severe sepsis every year. One third of these will die. Severe sepsis occurs when an infection affects the whole body and causes dysfunction of one or more of the major organs. A significant factor in this illness is that the body's normal response to infection or 'inflammatory response' becomes abnormal. It is not completely understood why the major organs can fail in severe sepsis. Organ failure is thought to be partly due to dysfunction of the small blood vessels that supply oxygen and nutrients to organs and tissues. We have previously shown that small blood vessel function is acutely impaired in patients with severe sepsis. The statins are a class of medications commonly used to lower cholesterol. Previous research in patients without sepsis suggests that they also have a beneficial effect on inflammation and on the function of small blood vessels. A clinical trial of atorvastatin in severe sepsis commenced in Australia and New Zealand in July 2007(The STATInS trial). The STATInS trial will be evaluating the safety of atorvastatin in severe sepsis and also its effect on inflammation and outcome. We propose to enroll a subset of patients from the STATInS trial into our study which will assess the effect of atorvastatin on the function of small blood vessels. 40-60% of our target recruitment will occur after the conclusion of the STATInS study, in a single-centre stand alone continuation of the study. This study will add valuable information to the STATInS trial, to help us answer questions about how and why atorvastatin helps patients with severe sepsis.
Interventions
Randomised allocation to atorvastatin 20mg capsules given orally or enterally once a day for up to 14 days.
Sponsors
Dr Josh Davis
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1) Admitted to the Intensive Care Unit 2) Severe sepsis for less than 24 hours. Severe sepsis is defined as strongly suspected or proven infection, 3 or more SIRS criteria and at least one acute organ dysfunction attributable to the sepsis.
Exclusion criteria
1) Pregnancy or breastfeeding2) Death is imminent3) History of intolerance to a statin4) Acute liver failure5) Child's C cirrhosis6) ALT>5x upper limit of normal7) CK > 5x upper limit of normal8) Patient unable to take oral or enteral medication9) Patient or next of kin not able to provide informed consent10) Patient, family or treating doctor not in favour of aggressive treatment11) Coagulopathy (INR>2.0 OR APTT>70)12) Severe thrombocytopaenia (Platelets<20)13) Latex allergy.
Outcome results
None listed