Abstract
ABSTRACTPreclinical animal studies precede the majority of clinical trials. While the clinical definitions of sepsis and recommended treatments are regularly updated, a systematic review of preclinical models of sepsis has not been done and clear modeling guidelines are lacking. To address this deficit, a Wiggers-Bernard Conference on preclinical sepsis modeling was held in Vienna in May, 2017. The goal of the conference was to identify limitations of preclinical sepsis models and to propose a set of guidelines, defined as the “Minimum Quality Threshold in Preclinical Sepsis Studies” (MQTiPSS), to enhance translational value of these models. A total of 31 experts from 13 countries participated and were divided into six thematic Working Groups: Study Design, Humane modeling, Infection types, Organ failure/dysfunction, Fluid resuscitation, and Antimicrobial therapy endpoints. As basis for the MQTiPSS discussions, the participants conducted a literature review of the 260 most highly cited scientific articles on sepsis models (2002–2013). Overall, the participants reached consensus on 29 points; 20 at “recommendation” and nine at “consideration” strength. This Executive Summary provides a synopsis of the MQTiPSS consensus. We believe that these recommendations and considerations will serve to bring a level of standardization to preclinical models of sepsis and ultimately improve translation of preclinical findings. These guideline points are proposed as “best practices” for animal models of sepsis that should be implemented. To encourage its wide dissemination, this article is freely accessible on the Intensive Care Medicine Experimental and Infection journal websites. In order to encourage its wide dissemination, this article is freely accessible in Shock, Infection, and Intensive Care Medicine Experimental.
Highlights
CF controls the Claes Frostell Research & Consulting AB company that participated in supporting several clinical and experimental studies
This is echoed by the US Food and Drug Administration (FDA) in their 2010 Guidance for Industry and FDA Staff: ‘‘FDA believes that the animal. . .(model). . .should provide a test system that offers a best attempt at simulating the clinical setting.’’ (General Considerations for Animal Studies for Cardiovascular Devices; www.fda.gov)
While the clinical definition of sepsis is currently in its third iteration [9] and the Surviving Sepsis Campaign Guidelines for patient management have been updated three times [10], preclinical sepsis research has not been subjected to any organized attempt at introducing best practices, management guidelines, and standardization [11]
Summary
While the clinical definitions of sepsis and recommended treatments are regularly updated, a systematic review of preclinical models of sepsis has not been done and clear modeling guidelines are lacking. To address this deficit, a Wiggers-Bernard Conference on preclinical sepsis modeling was held in Vienna in May, 2017. The participants reached consensus on 29 points; 20 at ‘‘recommendation’’ and nine at ‘‘consideration’’ strength This Executive Summary provides a synopsis of the MQTiPSS consensus. In order to encourage its wide dissemination, this article is freely accessible in Shock, Infection, and Intensive Care Medicine Experimental. ‘‘This modeling thing, it’s pretty easy, but it’s really tough.’’ Cara Delevingne
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