Sepsis

Abril 20, 2016. No. 2302

Diseño de ensayos fase 3 en sepsis: aplicación de las experiencias adquiridas a partir de ensayos de cuidados críticos en la insuficiencia cardíaca aguda. Designing phase 3 sepsis trials: application of learned experiences from critical care trials in acute heart failure. Mebazaa A1, Laterre PF2, Russell JA3, Bergmann A4, Gattinoni L5, Gayat E6, Harhay MO7, Hartmann O4, Hein F4, Kjolbye AL8, Legrand M9, Lewis RJ10,Marshall JC11, Marx G12, Radermacher P13, Schroedter M4, Scigalla P4, Stough WG14, Struck J4, Van den Berghe G15, Yilmaz MB16, Angus DC17. J Intensive Care. 2016 Mar 31;4:24. doi: 10.1186/s40560-016-0151-6. eCollection 2016. Abstract Substantial attention and resources have been directed to improving outcomes of patients with critical illnesses, in particular sepsis, but all recent clinical trials testing various interventions or strategies have failed to detect a robust benefit on mortality. Acute heart failure is also a critical illness, and although the underlying etiologies differ, acute heart failure and sepsis are critical care illnesses that have a high mortality in which clinical trials have been difficult to conduct and have not yielded effective treatments. Both conditions represent a syndrome that is often difficult to define with a wide variation in patient characteristics, presentation, and standard management across institutions. Referring to past experiences and lessons learned in acute heart failure may be informative and help frame research in the area of sepsis. Academic heart failure investigators and industry have worked closely with regulators for many years to transition acute heart failure trials away from relying on dyspnea assessments and all-cause mortality as the primary measures of efficacy, and recent trials have been designed to assess novel clinical composite endpoints assessing organ dysfunction and mortality while still assessing all-cause mortality as a separate measure of safety. Applying the lessons learned in acute heart failure trials to severe sepsis and septic shock trials might be useful to advance the field. Novel endpoints beyond all-cause mortality should be considered for future sepsis trials. KEYWORDS: Clinical trials as topic; Heart failure; Mortality; Multiple organ failure; Sepsis PDF Committee for European Education in Anaesthesiology (CEEA) Colegio de Anestesiólogos de León AC MÓDULO V: Sistema nervioso, fisiología, anestesia locoregional y dolor. Reconocimientos de: CEEA, CLASA, Consejo Nacional Mexicano de Anestesiología.   En la Ciudad de Léon, Guanajuato. México del 6 al 8 de Mayo, 2016. Informes en el tel (477) 716 06 16 y con el Dr. Enrique Hernández kikinhedz@gmail.com

Anestesiología y Medicina del Dolor 52 664 6848905 vwhizar@anestesia-dolor.org anestesia-dolor.org Copyright © 2015