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Designing phase 3 sepsis trials: Application of learned experiences from critical care trials in acute heart failure

Mebazaa, A and Laterre, PF and Russell, JA and Bergmann, A and Gattinoni, L and Gayat, E and Harhay, MO and Hartmann, O and Hein, F and Kjolbye, AL and Legrand, M and Lewis, RJ and Marshall, JC and Marx, G and Radermacher, P and Schroedter, M and Scigalla, P and Stough, WG and Struck, J and Van den Berghe, G and Yilmaz, MB and Angus, DC (2016) Designing phase 3 sepsis trials: Application of learned experiences from critical care trials in acute heart failure. Journal of Intensive Care, 4 (1).

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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.


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Item Type: Article
Status: Published
CreatorsEmailPitt UsernameORCID
Mebazaa, A
Laterre, PF
Russell, JA
Bergmann, A
Gattinoni, L
Gayat, E
Harhay, MO
Hartmann, O
Hein, F
Kjolbye, AL
Legrand, M
Lewis, RJ
Marshall, JC
Marx, G
Radermacher, P
Schroedter, M
Scigalla, P
Stough, WG
Struck, J
Van den Berghe, G
Yilmaz, MB
Angus, DCangusdc@pitt.eduANGUSDC0000-0002-7026-5181
Centers: Other Centers, Institutes, Offices, or Units > McGowan Institute for Regenerative Medicine
Date: 1 January 2016
Date Type: Publication
Access Restriction: No restriction; Release the ETD for access worldwide immediately.
Journal or Publication Title: Journal of Intensive Care
Volume: 4
Number: 1
DOI or Unique Handle: 10.1186/s40560-016-0151-6
Institution: University of Pittsburgh
Schools and Programs: School of Medicine > Clinical and Translational Science
School of Medicine > Critical Care Medicine
Refereed: Yes
Article Type: Review
Date Deposited: 20 Jul 2016 20:10
Last Modified: 30 Mar 2021 10:55


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