Sepsis Clinical Trial
Official title:
Preclinical Detection of Sepsis Early in Hospitalized Patients Following Surgery, Injury or Severe Illness (Pre-SEPSIS Trial)
This clinical study is to evaluate a novel biomarker - CNA Rapid Sepsis Dx - to predict the development of sepsis in patients admitted to the hospital with non-sepsis conditions. Using circulating cell-free DNA (cfDNA) in the blood stream, it has been demonstrated to detect infection response days before clinical evidence of sepsis manifests. The hypothesis is that blood biomarkers drawn daily in the hospital will identify patients who develop sepsis within seven days of hospital presentation.
This is a prospective observational trial evaluating CNA Rapid Sepsis Dx -novel biomarkers
(CNA Diagnostics Inc.; Calgary, Canada) based on circulating cell-free DNA (cfDNA) in the
blood stream to identify patients originally admitted with non-sepsis conditions who
ultimately develop sepsis according to Sepsis-3 criteria within seven days of hospital
presentation. This novel technology has been demonstrated to detect host-related response to
infection days before clinical evidence of sepsis manifests.
The primary objective of this study is to assess the performance of the novel diagnostic
assay, CNA Rapid Sepsis Dx, based on the biomarkers, drawn daily from the day of hospital
presentation, to identify patients who ultimately develop sepsis according to
Sepsis-3-definition within seven days of hospital presentation.
The secondary objective is to correlate the CNA Rapid Sepsis Dx with clinically relevant
outcomes such as infections that otherwise do not meet Sepsis-3 criteria, intensive care unit
(ICU) length of stay, hospital length of stay, fluid culture results, and hospital mortality.
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