Title |
Designing phase 3 sepsis trials: application of learned experiences from critical care trials in acute heart failure
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Published in |
Journal of Intensive Care, March 2016
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DOI | 10.1186/s40560-016-0151-6 |
Pubmed ID | |
Authors |
Alexandre Mebazaa, Pierre François Laterre, James A. Russell, Andreas Bergmann, Luciano Gattinoni, Etienne Gayat, Michael O. Harhay, Oliver Hartmann, Frauke Hein, Anne Louise Kjolbye, Matthieu Legrand, Roger J. Lewis, John C. Marshall, Gernot Marx, Peter Radermacher, Mathias Schroedter, Paul Scigalla, Wendy Gattis Stough, Joachim Struck, Greet Van den Berghe, Mehmet Birhan Yilmaz, Derek C. Angus |
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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United States | 2 | 13% |
United Kingdom | 2 | 13% |
Italy | 1 | 6% |
Mexico | 1 | 6% |
Spain | 1 | 6% |
Saudi Arabia | 1 | 6% |
Pakistan | 1 | 6% |
Unknown | 7 | 44% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 14 | 88% |
Science communicators (journalists, bloggers, editors) | 2 | 13% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 62 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 15 | 24% |
Other | 8 | 13% |
Student > Bachelor | 4 | 6% |
Student > Ph. D. Student | 4 | 6% |
Professor > Associate Professor | 4 | 6% |
Other | 10 | 16% |
Unknown | 17 | 27% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 22 | 35% |
Biochemistry, Genetics and Molecular Biology | 4 | 6% |
Agricultural and Biological Sciences | 3 | 5% |
Social Sciences | 3 | 5% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 3% |
Other | 9 | 15% |
Unknown | 19 | 31% |