ImmunoSep (Personalised Immunotherapy in Sepsis) international double-blind, double-dummy, placebo-controlled randomised clinical trial: study protocol

Sepsis is a major cause of death among hospitalized patients. Evidence suggests that immune response during the sepsis cascade lies within a spectrum of dysregulated host responses. On the one side of the spectrum, there are patients whose response is characterized by fulminant hyperinflammation or macrophage activation-like syndrome (MALS), and on the other side, patients whose immune response is characterized by immuno-paralysis. A sizeable group of patients are situated between the two extremes. Therefore, recognizing the immune endotype is very important to choose the appropriate immunotherapeutic approach for each patient resulting in the best chance to improve the outcome.