Presepsin (sCD14-ST) is an early predictor of outcome in patients with severe sepsis or septic shock : preliminary data from the Albumin Italian Outcome Sepsis (ALBIOS) study

Background: Sepsis, a leading cause of death in critically ill patients, is the result of complex interactions
between the infecting microorganisms and the host responses that influence clinical outcomes. Optimal
management requires early goal-oriented therapies and may benefit from individualized circulating
biomarkers for early risk stratification. We evaluated the prognostic value of presepsin (sCD14-ST), a novel
marker of bacterial infection.
Methods: This is a nested case-control study of the multicenter, randomized ALBIOS trial that enrolled
patients with severe sepsis or septic shock in 100 ICUs in Italy. We selected 50 survivors and 50 nonsurvivors
at the time of ICU discharge (21±18 days) matched for age, sex, center and time of enrolment after
the presence of inclusion criteria. EDTA-plasma samples were collected at days 1, 2 and 7 after enrolment to
assay presepsin (immune-chemiluminescence assay PATHFAST Presepsin, URL 320 pg/mL, CV 5%,
Mitsubishi Chemicals) and procalcitonin (PCT, Elecsys BRAHMS Cobas® PCT, URL 0.046 ng/mL, CV
8.8%, Roche Diagnostics) in a central laboratory.
Results: Clinical characteristics were similar in the 2 groups, but non-survivors had a worse SOFA score at
day 1. Patients with higher baseline presepsin had worse SOFA score, lower mean arterial pressure and
diuresis. Early presepsin (d1) was higher in decedents (2268[1145-4305] pg/mL, median[Q1-Q3]) than in
survivors (1184[855-2158] pg/mL, p=0.001) while PCT was not different (18.5[3.3-45.7] vs. 10.8[2.6-46.4]
ng/mL, p=0.31). Presepsin decreased over time in survivors but remained elevated in non-survivors
(974[674-1927] vs. 2551[1438-5624] pg/mL at d7, p=0.02 for time-survival interaction); PCT decreased
similarly in the 2 groups (p=0.19). Differences in presepsin vs. outcome were more marked in patients
enrolled 6-24 h after ICU admission, and in those with septic shock. Early presepsin had better prognostic
accuracy than PCT (AUROC at d1, 0.69 vs. 0.56, p=0.07) and improved discrimination over clinical SOFA
score.
Conclusions: We provide first evidence in a multicenter clinical trial that early presepsin measurement
provides relevant prognostic information in patients with severe sepsis or septic shock and may be of clinical
importance for early risk stratification.