Sepsis Clinical Trial
Official title:
Diagnostic and Prognostic Value of Serial PCT Measurements in Critically Ill Patients
In 2005, the Food and Drug Administration (FDA) approved procalcitonin in conjunction with other laboratory markers to aid in the risk assessment of critically ill patients with severe infection (sepsis). Although considerable literature exists regarding the usefulness of Procalcitonin (PCT) as a marker of sepsis, there are still potential uses for PCT measurements that are not yet explored and its value among the critically ill patients remains unclear. This study seeks to better understand the usefulness of measuring PCT values in patients admitted to the Medical ICU for a variety of reasons and in particular with severe infection (sepsis).
Procalcitonin (PCT) is a 116 amino acid peptide that has an approximate MW of 14.5 kDa and
belongs to the calcitonin (CT) superfamily of peptides. Transcription of the CALC-1 gene for
PCT is usually suppressed in the non-neuroendocrine tissue, except in the C cells of the
thyroid gland where its expression produces PCT, the precursor of CT in healthy individuals
and in the absence of infection.
In the presence of microbial infection, circulating levels of calcitonin precursors (CTpr),
including PCT, increase up to several thousand-fold.1 In addition to being a marker of
microbial infection, PCT also acts as a modulator of the host inflammatory reaction. In an
animal model of sepsis, administration of exogenous human PCT worsened outcome, whereas
neutralization of endogenous PCT improved survival.
There are several inflammatory laboratory markers, like tumor necrosis factor (TNF)-α,
interleukin (IL)-1, IL-6 and C-reactive protein (CRP), but they are non- specific for
infection and can be caused by conditions like pancreatitis, burns, trauma or acute lung
injury. The non-specific nature of clinical and laboratory parameters for microbial
infection makes it difficult to evaluate patients with potential infection. In addition to
the lack of specificity, traditional laboratory and clinical indicators of sepsis are not
temporally concordant with the course of illness. As a result, these tests are not reliable
to evaluate the response to therapeutic interventions in real time.
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