Septic Shock Clinical Trial
Official title:
Soluble Form of the Receptor for Advanced Glycation End Products (sRAGE) Levels in the Pulmonary Edema Fluid and Plasma From ICU Patients With ALI/ARDS and Severe Sepsis : an Observational Prospective Study.
sRAGE, the soluble form of the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury, but is also involved in acute systemic inflammation. The purpose of this observational prospective study is to determine whether sRAGE could be used in an ICU setting as a potential diagnostic and prognostic marker during ALI/ARDS, regardless of associated severe sepsis or septic shock.
BACKGROUND:
The receptor for advanced glycation end products (RAGE was recently identified as a
promising new marker of alveolar type I cell injury. RAGE is a member of the immunoglobulin
superfamily that acts as a multiligand receptor and is involved in propagating inflammatory
responses. While the precise function of RAGE remains unclear, the elevated levels of RAGE,
and its soluble isoform sRAGE, correlate with severity of ALI/ARDS in human and animal
studies, and RAGE levels could reflect impaired alveolar fluid clearance. Thus, it is
possible that elevated levels of RAGE in ALI/ARDS derive in part from RAGE's role in
systemic inflammatory cascades rather than purely from its release from alveolar type I
cells.
DESIGN NARRATIVE:
This observational prospective clinical study will describe and compare sRAGE levels in the
alveolar edema fluid and in the plasma from ICU patients enrolled within the first 24 hours
after onset of ALI/ARDS and/or severe sepsis/septic shock, and from patients under
mechanical ventilation (control group). Edema fluid and plasma samples will be collected
simultaneously on day 1, day 3, day 6, and day 28 (or at ICU discharge), in order to
describe kinetics of evolution of sRAGE levels. Undiluted pulmonary edema fluid samples will
be collected in intubated patients only, and blood samples will be gathered from an
indwelling arterial catheter. The concentrations of sRAGE will be measured in duplicate by
ELISA.
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Time Perspective: Prospective
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