Title: Designing phase 3 sepsis trials: application of learned experiences from critical care trials in acute heart failure
Authors: Mebazaa, Alexandre ×
Laterre, Pierre François
Russell, James A
Bergmann, Andreas
Gattinoni, Luciano
Gayat, Etienne
Harhay, Michael O
Hartmann, Oliver
Hein, Frauke
Kjolbye, Anne Louise
Legrand, Matthieu
Lewis, Roger J
Marshall, John C
Marx, Gernot
Radermacher, Peter
Schroedter, Mathias
Scigalla, Paul
Stough, Wendy Gattis
Struck, Joachim
Van den Berghe, Greet
Yilmaz, Mehmet Birhan
Angus, Derek C #
Issue Date: 2016
Publisher: BioMed Central
Series Title: Journal of Intensive Care vol:4 pages:24
Article number: 10.1186/s40560-016-0151-6
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.
ISSN: 2052-0492
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory of Intensive Care Medicine
× corresponding author
# (joint) last author

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