Sepsis Clinical Trial
Official title:
Changes in 13CO2/12CO2 Delta Value in Exhaled Breath as an Early Indicator of Infection in Adult Trauma Subjects
Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide. The ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value. This study is seeking to determine if the breath delta value of adults with trauma is an early indicator of the onset of infection that may lead to sepsis.
Breath delta value is hypothesized to be a biomarker of infection. Breath delta value is not
a defined clinical outcome related to human health, because this study is seeking to
establish breath delta value as a biomarker of infection. This study is measuring the
feasibility of the Isomark Canary™ device. If the Canary doesn't detect a significant
decrease in breath delta value in those subjects who subsequently get an infection, it will
not be feasible to use it for this purpose.
Breath delta value will be collected to determine its relationship to infection, no health
outcomes are being measured.
In this single-center study of 110 subjects, breath samples will be collected 6 times per
day and blood samples will be collected once per day for 7 days. Subjects will be followed
for an additional 3 days. Analysis results of these samples will be combined with data that
is abstracted from the subjects' medical records. The investigators hypothesize that the
measurement of 13C/12C delta value in the exhaled breath of adults is an early indicator of
infection in subjects with systemic inflammatory response syndrome secondary to trauma.
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Intervention Model: Single Group Assignment, Masking: Open Label
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