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Intensive Care Medicine
Published in: Intensive Care Medicine 3/2005

01-03-2005 | Correspondence

Safety of endotoxin challenge in healthy volunteers: bradycardia

Author: Bernd Jilma

Published in: Intensive Care Medicine | Issue 3/2005

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Excerpt

Sir: human endotoxemia is a well-standardized and safe model to study systemic inflammation or coagulation [1, 2] and the pharmacodynamic effects of novel therapeutic agents during early phase drug development [3]. Recently, van Eijk et al. have reported the occurrence of severe bradycardia or protracted asystole after infusion of endotoxin [4]. They had observed two cases during their study. In addition, two further cases were identified after review of the published literature [5] and interviews by three established investigators, who challenged approximately 2,200 subjects with Reference Endotoxin E. coli: 0113 in the last 25 years [4]. …
Literature
1.
Fiuza C, Suffredini AF (2001) Human models of innate immunity: local and systemic inflammatory responses. J Endotoxin Res 7:385–388
2.
Martich GD, Boujoukos AJ, Suffredini AF (1993) Response of man to endotoxin. Immunobiology 187:403–416PubMed
3.
Jilma B, Marsik C, Mayr F, Graninger MT, Taylor FB Jr, Ribel MC, Erhardtsen E, Handler S, Eichler HG (2002) Pharmacodynamics of active site-inhibited factor VIIa in endotoxin-induced coagulation in humans. Clin Pharmacol Ther 72:403–410
4.
van Eijk LT, Pickkers P, Smits P, Bouw MP, van der Hoeven JG (2004) Severe vagal response after endotoxin administration in humans. Intensive Care Med (E-pub ahead of publication)
5.
Williams WV, Fullerton T, Fox JC, Enslin MB, Murray L, Jorkasky D (2000) Asystole following endotoxin administration. J Endotoxin Res 6:303–306PubMed
6.
Pernerstorfer T, Schmid R, Bieglmayer C, Eichler HG, Kapiotis S, Jilma B (1999) Acetaminophen has greater antipyretic efficacy than aspirin in endotoxemia: a randomized, double-blind, placebo-controlled trial. Clin Pharmacol Ther 66:51–57
Metadata
Title
Safety of endotoxin challenge in healthy volunteers: bradycardia
Author
Bernd Jilma
Publication date
01-03-2005
Publisher
Springer-Verlag
Published in
Intensive Care Medicine / Issue 3/2005
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-005-2562-z

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