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Open Access 01-11-2008 | Editorial

Editors’ comments on a new trial of activated protein C for persistent septic shock

Authors: Jordi Mancebo, Massimo Antonelli

Published in: Intensive Care Medicine | Issue 11/2008

Excerpt

This month’s issue of the Journal contains a somewhat unusual article and two accompanying editorials [1‐3]. The authors of the article are members of the steering committee of an ongoing Eli-Lilly trial on activated protein C for persistent septic shock. They describe a number of steps that have been adopted in order to ensure transparency in disclosing financial conflicts, facilitate comprehension and interpretation of results, minimize possible risks, and maximize eventual benefits for patients. This approach constitutes a new model of academia-industry collaboration. …

Finfer S, Ranieri V, Thompson B, Barie P, Dhainaut J, Douglas I, Gardlund B, Marshall J, Rhodes A (2008) Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock. Intensive Care Med. doi:10.1007/s00134-008-1266-6

Sweeney DA, Danner RL, Eichacker PQ, Natanson C (2008) Once is not enough: clinical trials in sepsis. Intensive Care Med 34. doi:10.1007/s00134-008-1274-6

Takala J, Suter PM (2008) Science, medicine and industry: are we getting out of the black hole in sepsis research. Intensive Care Med 34. doi:10.1007/s00134-008-1302-6

Bernard GR, Vincent J-L, Laterre P-F, LaRosa SP, Dhainaut J-F, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ (2001) Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 344:699–709PubMedCrossRef

Wenzel RP (2002) Treating sepsis. N Engl J Med 347:966–967PubMedCrossRef

Warren HS, Suffredini AF, Eichacker PQ, Munford RS (2002) Risks and benefits of activated protein C treatment for severe sepsis. N Engl J Med 347:1027–1030PubMedCrossRef

Siegel JP (2002) Assessing the use of activated protein C in the treatment of severe sepsis. N Engl J Med 347:1030–1034PubMedCrossRef

Ely EW, Bernard GR, Vincent J-L (2002) Activated protein C for severe sepsis. N Engl J Med 347:1035–1036PubMedCrossRef

Eichacker PQ, Danner RL, Suffredini AF, Cui X, Natanson C (2005) Reassessing recombinant human activated protein C for sepsis: time for a new randomized controlled trial. Crit Care Med 33:2426–2428PubMedCrossRef

10.

Bertolini G, Rossi C, Anghileri A, Livigni S, Addis A, Poole D (2007) Use of Drotrecogin alfa (activated) in Italian intensive care units: the results of a nationwide survey. Intensive Care Med 33:426–434PubMedCrossRef

11.

Kanji S, Perreault MM, Chant C, Williamson D, Burry L (2007) Evaluating the use of Drotrecogin alfa (activated) in adult severe sepsis: a Canadian multicenter observational study. Intensive Care Med 33:517–523PubMedCrossRef

12.

Eichacker PQ, Natanson C (2007) Increasing evidence that the risks of rhAPC may outweigh its benefits. Intensive Care Med 33:396–399PubMedCrossRef

13.

Eichacker PQ, Natanson C, Danner RL (2006) Surviving sepsis–practice guidelines, marketing campaigns, and Eli Lilly. N Engl J Med 355:1640–1642PubMedCrossRef

14.

Ranieri VM, Moreno RP, Rhodes A (2007) The European Society of Intensive Care Medicine (ESICM) and the Surviving Sepsis Campaign (SSC). Intensive Care Med 33:423–425PubMedCrossRef

Title: Editors’ comments on a new trial of activated protein C for persistent septic shock
Authors: Jordi Mancebo
Massimo Antonelli
Publication date: 01-11-2008
Publisher: Springer-Verlag
Published in: Intensive Care Medicine / Issue 11/2008
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI: https://doi.org/10.1007/s00134-008-1303-5

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Editors’ comments on a new trial of activated protein C for persistent septic shock

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