Endpoints in sepsis trials: more than just 28-day mortality?

To determine whether an intervention, either therapeutic or diagnostic, is effective, it needs to be assessed according to a predefined endpoint (or outcome measure), the choice of which will vary according to the aims of the study in question and the anticipated effects of the intervention being tested. Studies can have one of several functions (which are not always mutually exclusive), including providing evidence of biological efficacy, determining a clinically important benefit, and achieving regulatory approval. In trials of therapeutic efficacy in sepsis, mortality rates are a good endpoint because death is common and mortality rates are an unambiguous measure: patients either survive or they do not. However, the time at which mortality should be recorded is less clear cut, and this single endpoint provides no information regarding the biological activity or disease modification effects of the agent under investigation. In this article, we will briefly discuss some of the potential alternative endpoints that could be used in the assessment of antisepsis agents.