Any investigator conducting a sepsis trial has to face a fundamental and vexing methodological
problem with no simple fix. There is no definitive way to know for sure which subjects
actually have the condition. In medical practice, sepsis is a clinical diagnosis based
on a constellation of signs and symptoms coupled with a suspicion for infection as
the inciting event. But the problem is that sepsis lacks a diagnostic gold standard
test.
1
Blood cultures growing pathogenic bacteria –the most unimpeachable marker of infection
– are positive only in a minority of suspected sepsis patients.
2
And positive cultures from other sites – such as sputum or urine – cannot reliably
distinguish colonization from invasive infection.
3
,4
When it comes to treating patients with suspected sepsis, doctors sacrifice specificity
for sensitivity so as not to delay early and potentially life-saving treatment. As
a result, many patients are presumptively diagnosed with sepsis who later are determined
to have non-infectious conditions.To read this article in full you will need to make a payment
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References
- Opening the debate on the new sepsis definition change is not necessarily progress: revision of the sepsis definition should be based on new scientific insights.Am J Respir Crit Care Med. 2016; 194: 16-18
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- Retrospective identification of infection in the emergency department: a significant challenge in sepsis clinical trials.Am J Med Sci. 2022; S0002-9629 (Epub ahead of print): 00080-00085https://doi.org/10.1016/j.amjms.2022.02.008
Article info
Publication history
Published online: April 10, 2022
Accepted:
April 4,
2022
Received:
March 31,
2022
Identification
Copyright
© 2022 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.
