Serial Procalcitonin Predicts Mortality in Severe Sepsis Patients: Results From the Multicenter Procalcitonin MOnitoring SEpsis (MOSES) Study

<jats:sec> <jats:title>Objectives:</jats:title> <jats:p>To prospectively validate that the inability to decrease procalcitonin levels by more than 80% between baseline and day 4 is associated with increased 28-day all-cause mortality in a large sepsis patient population recruited across the United States.</jats:p> </jats:sec> <jats:sec> <jats:title>Design:</jats:title> <jats:p>Blinded, prospective multicenter observational clinical trial following an Food and Drug Administration-approved protocol.</jats:p> </jats:sec> <jats:sec> <jats:title>Setting:</jats:title> <jats:p>Thirteen U.S.-based emergency departments and ICUs.</jats:p> </jats:sec> <jats:sec> <jats:title>Patients:</jats:title> <jats:p>Consecutive patients meeting criteria for severe sepsis or septic shock who were admitted to the ICU from the emergency department, other wards, or directly from out of hospital were included.</jats:p> </jats:sec> <jats:sec> <jats:title>Interventions:</jats:title> <jats:p>Procalcitonin was measured daily over the first 5 days.</jats:p> </jats:sec> <jats:sec> <jats:title>Measurements and Main Results:</jats:title> <jats:p>The primary analysis of interest was the relationship between a procalcitonin decrease of more than 80% from baseline to day 4 and 28-day mortality using Cox proportional hazards regression. Among 858 enrolled patients, 646 patients were alive and in the hospital on day 4 and included in the main intention-to-diagnose analysis. The 28-day all-cause mortality was two-fold higher when procalcitonin did not show a decrease of more than 80% from baseline to day 4 (20% vs 10%; <jats:italic toggle="yes">p</jats:italic> = 0.001). This was confirmed as an independent predictor in Cox regression analysis (hazard ratio, 1.97 [95% CI, 1.18–3.30; <jats:italic toggle="yes">p</jats:italic> < 0.009]) after adjusting for demographics, Acute Physiology and Chronic Health Evaluation II, ICU residence on day 4, sepsis syndrome severity, antibiotic administration time, and other relevant confounders.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>Results of this large, prospective multicenter U.S. study indicate that inability to decrease procalcitonin by more than 80% is a significant independent predictor of mortality and may aid in sepsis care.</jats:p> </jats:sec>