Grant: Operating Grant: Clinical Trials Projects

Sepsis is a life-threatening condition where the body's normal functions required to maintain life are threatened by a severe infection. After leaving the hospital, sepsis survivors remain at high risk for additional infections or heart problems. Currently there are no drugs which improve outcomes after patients leave the hospital. We propose to investigate whether a common cholesterol-lowering medicine used to prevent heart disease may also help prevent patients needing to come back to the hospital or dying in the year after surviving severe infection (sepsis). There is scientific rationale that atorvastatin may reduce those risks. However, there have been few trials of treatments after sepsis (and none in Canada), so we believe that the first step it to perform a 'test' trial (called a "feasibility trial"), where we perform the trial on a much smaller scale with fewer patients to make sure we understand all the processes and potential considerations that may arise in a bigger trial. This helps reduce the risk that the bigger trial fails to answer the question, leaving scientific uncertainty, at great expense to society and patients. This also provides the opportunity to assure that the planned trial processes and outcomes are aligned with patients' values and preferences. This way, we can assure that the bigger trial results are meaningful in ways that mean most to patients, and to make the trial experience optimal for participants. This feasibility trial will help doctors take the first step to finding ways to help patients in the year after sepsis. This approach will also help when the next pandemic arrives, as doctors will have learned more about: (1) what happens after severe infection, (2) which treatments might help, and (3) how to best perform trials in this patient population - as well as (4) build a system for studying infection survivors which can be used to efficiently study treatment during the next pandemic.