Endothelial Dysfunction Clinical Trial
Official title:
Endothelial Dysfunction and Selenium Status in Children With Acute Systemic Inflammatory
The overall hypotheses of this project is that severe sepsis is associated with endothelial dysfunction in pediatric patients and that selenium deficiency is associated with changes in biological markers of endothelial dysfunction and that these changes, in turn, are associated with worse clinical prognosis.
Background: Oxidative stress occurs during shock as a result of granulocytes and endothelial
cell activation. Higher intensity of endothelial activation is associated with unfavorable
outcomes. Selenium is an essential trace element that plays a key role in the antioxidant
defenses and whose plasma concentrations have been low in critically ill patients. There are
no clinical studies, especially in pediatric patients that consider the roles of selenium and
nutritional status in the modulation of endothelial adaptive response during the inflammatory
response secondary to shock. The investigators hypothesize that selenium deficiency is
associated with changes in biological markers of endothelial dysfunction and that these
changes, in turn, are associated with worse clinical prognosis. Objectives: 1) to investigate
the association between selenium (Se) status and the endothelial activation in children
during acute systemic inflammatory response and 2) to investigate whether the intensity of
endothelial activation can predict the clinical outcome in children with systemic
inflammatory response.
Methodology: prospective, observational study in children admitted to an intensive care unit
(ICU) with systemic inflammatory response. The primary outcome will be 'intensity endothelial
activation' which will be defined based on biological markers (SE-selectin, soluble
intercellular molecule 1 of Vascular Cell adhesion Molecule and soluble adhesion-1). The
association between the state of Se (anthropometric measurements, blood levels of selenium
and erythrocyte glutathione peroxidase, selenoprotein P activity) and this outcome will be
investigated in a multiple logistic model considering age, gender, primary diagnosis,
prognostic scores and clinical characteristics. The secondary outcome will be 'clinical
prognosis' which will be defined based on 'organ dysfunction' (creatinine level, platelets
level and arterial hypotension), infectious complications during the staying in ICU and death
up to 28 days. In this step the explanatory variables will be the same used in the first
analyse plus to 'intensity of endothelial activation'. Participants will be followed for the
duration of ICU/Hospital stay, an expected average of 28 days. Particularly, biological
markers of endothelial activation will be evaluated in three different times: at baseline and
on days 3 and 5 ICU. Expected results: if the study hypotheses are correct, they may justify
the analysis of biomarkers of endothelial activation in medical practice and in future
studies assessing the benefits of selenium supplementation in critical illness.
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