Observational study of septic shock

The observational clinical study was approved by the local ethics committee (Ethics Committee of the Medical Faculty of Heidelberg, Trial Code No. S-097/2013/German Clinical Trials Register: DRKS00005463) and was conducted in the surgical intensive care unit of Heidelberg University Hospital, Germany, between November 2013 and January 2015. All study patients or their legal designees gave written informed consent. In total 50 patients suffering from septic shock according to the criteria of the Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock 2012 were enrolled in this study [106 (link)]. Treatment of patients with septic shock included early-goal directed therapy [107 (link)], elimination of the septic focus and broad-spectrum antibiosis [3 (link),107 (link),108 (link)]. Blood samples were collected at sepsis onset (T0) and 1 day (T1), 2 days (T2), 7 days (T3) 14 days (T4), 21 days (T5), and 28 days (T6) thereafter. Relevant baseline data (demographic data, primary site of infection), clinical data (disease severity scores, such as Simplified Acute Physiology Score (SAPS II), Sequential Organ Failure Assessment Score (SOFA) and Acute Physiology Health Evaluation score (APACHE II), surgical procedures, antifungal therapy, outcome parameters) as well as routine infection parameters (e.g. leukocytes, C-reactive protein (CRP), procalcitonin (PCT), body temperature) were collected.