Sepsis outcomes, why have we failed?

Monday 5 June, 16h00-16h45 Room 5

This “Meet the Expert” session will look at the various problems encountered with sepsis studies over recent years. The speaker is Professor Frank Brunkhorst, Jena University Hospital, Germany. Since 2001 Prof Brunkhorst has been Secretary-General of the German Sepsis Society and in 2005 received the Award of the German Federal Cross of Merit from the President of Germany for clinical and scientific work in the field of severe infections and sepsis.

During the last two decades, multiple treatment modalities have been tested in the attempt to improve clinical outcomes from sepsis. “During this period we have consistently observed initially promising results that have gradually faded in subsequent trials,” says Prof Brunkhorst. “Researchers blame this irreproducibility on slow patient accrual (selection bias), the Hawthorn effect (knowing you are being watched changes your practice), beta-type errors (false positive), publication bias and other factors.”

He will also refer to a recent publication (Mebazaa et al. Journal of Intensive Care (2016) 4:24) which says that the major reasons for lack of survival in recent sepsis trials are over-estimated treatment effects, suboptimal pre-clinical models, incorrect treatment targets, and heterogeneity of definitions and patients.

Prof Brunkhorst concludes: “Priorities for future sepsis clinical trials are among others, identification of responders to treatment, networks of sepsis investigators experienced in clinical trial conduct, application of the recent S-3 definitions for sepsis and septic shock, targeted clinical trials in relatively homogeneous groups of patients, and pre-specified covariate adjustment of the primary endpoint (heterogeneity) and exclusion of low-risk patients.”