Sepsis Clinical Trial
Official title:
Early Prediction of Severe Sepsis (ExPRESSepsis) Study
Between 6 and 16% of patients presenting to hospital emergency departments have infections,
with half of these having signs of systemic inflammation (known as 'sepsis'). A second issue
is that, at time of presentation, it can be difficult to determine who has inflammation as a
result of infection and who does not.
Some of the patients with infections will deteriorate to organ failure ('severe sepsis')
including failure of the heart and blood vessels to maintain normal blood pressure ('septic
shock'). Septic shock as arguably the most dangerous form of severe sepsis is associated
with a significant mortality, which can be reduced by early intervention. However
identifying those patients who are at high risk of deteriorating to septic shock can be
difficult on initial presentation to hospital, and thus these patients risk being 'triaged'
to an inappropriate level of care and/or missing the crucial early interventions which can
modify mortality. Equally failure to identify which patients have underlying infections can
lead to potential inappropriate targeting of antibiotics. Existing clinical and laboratory
tests are often unable to accurately identify those patients with infection, and those who
are likely to deteriorate to severe sepsis and septic shock.
Investigators in this group have recently identified several signatures of immune system
activation which predict those patients who are likely to deteriorate, and which patients
with suspected infection subsequently have this confirmed. Such tests would have major
benefits for the management of patients with early suspected infection and sepsis if they
can be translated into a test usable in everyday clinical practice. This study aims to
determine the prevalence of these markers in a cohort of patients admitted with suspected
sepsis, and their predictive ability for developing established septic shock. From this
investigators aim to derive an optimal test, to be tested in a validation cohort
(ExPRES-Sepsis II) which will be suitable for everyday clinical practice, and thus take the
next step towards developing a market-ready test.
Study hypothesis is:
Measurement of markers of immune activation will allow i) Risk stratification for
deterioration into severe sepsis ii) Risk stratification for death amongst patients
presenting with sepsis iii) Identification of patients with confirmed sepsis
n/a
Observational Model: Cohort, Time Perspective: Prospective
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Active, not recruiting |
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