Clinical Trials for the Treatment of Sepsis

The incidence of sepsis is increasing as new medical and surgical technologies are applied to an increasingly aging patient population. The treatment of sepsis emphasizes strategies to avoid multiple organ dysfunction, with particular attention to establishing source control, and then modifies the host's response to the excessive inflammatory response which characterizes sepsis. This book is a comprehensive review by internationally recognized experts of the epidemiology, monitoring and treatment of sepsis. Using an "evidence-based" approach, it comprises an extensive review of the literature on sepsis, provides up-to-date recommendations for monitoring and treating sepsis patients, and concludes with explicit recommendations for the design and monitoring of future clinical trials.

Sepsis and Innovative Treatment: The Odyssey R. C. Bone The Odyssey by Homer, dates back to the 8th century, B. C. 1]. It is a great epic adventure of Odysseus's dramatic journey from Troy back home to Ithaca. Odysseus survives the ordeals of this journey and returns with new powers and insights. The study of the pathogenesis and treatment of sepsis has also been an odys- sey. I feel we will return from this odyssey with new insights and treatments. However, as with Odysseus, this will occur only after considerable struggle. In the 1980s we had a rather simplistic view of sepsis. It was a highly lethal complication caused by infection and often charac- terized by shock and multi-organ failure. Our knowledge of the inflammatory responses associated with sepsis was embryonic compared to today. The inflammatory response was often treat- ment with mega-dose corticosteroids along with fluid resuscita- tion, vasopressors and antibiotics. Because of the paucity of mul- ti-center controlled trials documenting the risk/benefit ratio of the treatment of sepsis with corticosteroids, two large multi-cen- ter controlled trials were organized to evaluate the role of corti- costeroids in sepsis 2, 3]. Because animal models showed bene- fits of corticosteroids only with pre-treatment or early treatment, a definition of sepsis was used that did not require positive cul- ture documentation or septic shock to be included in the studied population.

From the contents: The "At Risk" Patient Population.- ARDS and Sepsis.- Measurement of Inflammatory Mediators in Clinical Sepsis.- What Determines Prognosis in Sepsis.- Evidence-Based Analysis of Nutrition Support in Sepsis.- Anti-Endotoxin Therapy.- The Monitoring and Reporting of Clinical Trials.- Ehtical Issues in Clinical Trials.