• Philipp Schuetz, Robert Birkhahn, Robert Sherwin, Alan E Jones, Adam Singer, Jeffrey A Kline, Michael S Runyon, Wesley H Self, D Mark Courtney, Richard M Nowak, David F Gaieski, Stefan Ebmeyer, Sascha Johannes, Jan C Wiemer, Andrej Schwabe, and Nathan I Shapiro.
• 1Division of General and Emergency Medicine, University Department of Medicine, Kantonsspital Aarau, Aarau, Switzerland; and Medical Faculty, University of Basel, Switzerland. 2Department of Emergency Medicine, New York Methodist Hospital, New York, NY. 3Emergency Departments, Sinai Grace Hospital and Detroit Receiving Hospital, Detroit, MI. 4Department of Emergency Medicine, University of Mississippi Medical Center, Jackson, MS. 5Department of Emergency Medicine, Stony Brook University, Stony Brook, NY. 6Department of Emergency Medicine, Carolinas Medical Center, Charlotte, NC. 7Department of Emergency Medicine, Vanderbilt University, Nashville, TN. 8Department of Emergency Medicine, Northwestern University, Chicago, IL. 9Department of Emergency Medicine, Henry Ford Health System, Detroit, MI. 10Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA. 11Global Medical Affairs, B·R·A·H·M·S GmbH, Hennigsdorf, Germany. 12Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA.
• Crit. Care Med. 2017 May 1; 45 (5): 781-789.

ObjectivesTo 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.DesignBlinded, prospective multicenter observational clinical trial following an Food and Drug Administration-approved protocol.SettingThirteen U.S.-based emergency departments and ICUs.PatientsConsecutive 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.InterventionsProcalcitonin was measured daily over the first 5 days.Measurements And Main ResultsThe 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%; p = 0.001). This was confirmed as an independent predictor in Cox regression analysis (hazard ratio, 1.97 [95% CI, 1.18-3.30; p < 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.ConclusionsResults 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.

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