A rapid qualitative assay to detect circulating endotoxin can predict the development of multiorgan dysfunction

Objective: To determine whether a rapid qualitative assay for the detection of circulating endotoxin (SimpliRED Endotoxin Test [SRE]; AGEN, Inc; Brisbane, Australia) can predict the occurrence of multiorgan dysfunction and hospital mortality. To compare the SRE to the limulus amebocyte lysate (LAL) assay as a predictor of clinical outcomes. Design: Prospective, blinded, single-center study. Setting: Medical ICU of Barnes- Jewish Hospital, St. Louis, a university-affiliated teaching hospital. Patients: Included in the study were 265 adult patients requiring medical ICU admission. Interventions: Daily collection of blood samples. Measurements and results: Daily detection for the presence of endotoxin in blood during intensive care and assessment for the development of multiorgan dysfunction (ie, an organ system failure index >2) or death. On ICU day 1, 55 (20.8%) patients had circulating endotoxin detected by the SRE. On ICU day 2, 29 of the 143 (20.3%) patients remaining in the ICU had a positive SRE. The development of multiorgan dysfunction was significantly greater among SRE- positive patients (44.8%) compared to SBE-negative patients (21.9%) on ICU day 2 (p=0.013). Multiple logistic regression analysis identified a positive SRE on ICU day 2 (adjusted odds ratio, 4.1; 95% confidence interval, 2.5 to 6.8; p=0.006) as being independently associated with the development of multiorgan dysfunction. A positive SRE test was not predictive of hospital mortality. Direct quantitative measurement of the concentration of circulating endotoxin using the LAL assay was not associated with either the development of multiorgan dysfunction or hospital mortality (p>0.1). Conclusions: Our preliminary data suggest that a bedside assay to qualitatively detect circulating endotoxin is predictive of the development of multiorgan dysfunction among patients admitted to a medical ICU. The rapid detection of circulating endotoxin could be useful for stratifying patients into various risk categories for the development of multiorgan dysfunction.