Gram Negative Septic Shock Clinical Trial
Official title:
Endotoxin Activity Assay as a Prognostic Factor in Gram-negative Septic Shock
The purpose of this observational study is to determine whether endotoxin levels and/or their trends can be considered predictive of morbility or mortality in septic shock caused by gram-negative bacteria, searching also for a possible correlation with Simplified Acute Physiology Score (SAPS II), Sequential Organ Failure Assessment (SOFA), White Blood Cells (WBC) and Platelets (PLT).
Medical literature states that Endotoxin (a structural molecule of the Gram-negative
bacteria extracellular membrane) is able to activate target cells such as macrophages and
neutrophils, inducing them to produce and release cytokine, nitric oxide and other mediators
that cause a systemic inflammatory response that can evolve until to endothelial damage,
shock and multi-organ failure (MOF).
Since 2004 it has been possible to better determine the concentration and the activity of
endotoxin in plasma, thanks to a reliable and quick to implement method: the EAA (Endotoxin
Activity Assay) test, which is an alternative technique for detecting endotoxin in whole
blood based on the detection of enhanced respiratory burst activity in neutrophils following
their priming by complexes of endotoxin and a specific anti-endotoxin antibody. The EAA
shows excellent performance characteristics in recovering endotoxin from spiked samples and
can be performed within 30 min, using less than 100µl whole blood.
Participants of this study (all affected by gram-negative septic shock) will show different
values of endotoxin in their blood samples during their stay in Intensive Care Unit (ICU),
and the investigators will try to figure out if these values and their trends can be somehow
predictive of morbility and/or mortality, despite the small number of septic patients and
the heterogeneity of their clinical picture.
So, if endotoxin induces sepsis, can the investigators also state that high values and/or
trends of endotoxin can be correlated to severity of disease?
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Observational Model: Cohort, Time Perspective: Prospective