Critical Care Medicine

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Critical Care Medicine:
doi: 10.1097/CCM.0b013e31821e8791
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Procalcitonin-guided interventions against infections to increase early appropriate antibiotics and improve survival in the intensive care unit: A randomized trial*

Jensen, Jens U. MD, PhD; Hein, Lars MD; Lundgren, Bettina MD, DMSc; Bestle, Morten H. MD, PhD; Mohr, Thomas T. MD, PhD; Andersen, Mads H. MD; Thornberg, Klaus J. MD; Løken, Jesper MD; Steensen, Morten MD; Fox, Zoe MD, PhD; Tousi, Hamid MD; Søe-Jensen, Peter MD; Lauritsen, Anne Ø MD; Strange, Ditte MD; Petersen, Pernille L. MD; Reiter, Nanna MD; Hestad, Søren MD; Thormar, Katrin MD; Fjeldborg, Paul MD; Larsen, Kim M. MD; Drenck, Niels E. MD; Østergaard, Christian MD, PhD, DMSc; Kjær, Jesper MSc; Grarup, Jesper DVM; Lundgren, Jens D. MD, DMSc; for The Procalcitonin And Survival Study (PASS) Group

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Objective: For patients in intensive care units, sepsis is a common and potentially deadly complication and prompt initiation of appropriate antimicrobial therapy improves prognosis. The objective of this trial was to determine whether a strategy of antimicrobial spectrum escalation, guided by daily measurements of the biomarker procalcitonin, could reduce the time to appropriate therapy, thus improving survival.

Design: Randomized controlled open-label trial.

Setting: Nine multidisciplinary intensive care units across Denmark.

Patients: A total of 1,200 critically ill patients were included after meeting the following eligibility requirements: expected intensive care unit stay of ≥24 hrs, nonpregnant, judged to not be harmed by blood sampling, bilirubin <40 mg/dL, and triglycerides <1000 mg/dL (not suspensive).

Interventions: Patients were randomized either to the “standard-of-care-only arm,” receiving treatment according to the current international guidelines and blinded to procalcitonin levels, or to the “procalcitonin arm,” in which current guidelines were supplemented with a drug-escalation algorithm and intensified diagnostics based on daily procalcitonin measurements.

Measurements and Main Results: The primary end point was death from any cause at day 28; this occurred for 31.5% (190 of 604) patients in the procalcitonin arm and for 32.0% (191 of 596) patients in the standard-of-care-only arm (absolute risk reduction, 0.6%; 95% confidence interval [CI] −4.7% to 5.9%). Length of stay in the intensive care unit was increased by one day (p = .004) in the procalcitonin arm, the rate of mechanical ventilation per day in the intensive care unit increased 4.9% (95% CI, 3.0–6.7%), and the relative risk of days with estimated glomerular filtration rate <60 mL/min/1.73 m2 was 1.21 (95% CI, 1.15–1.27).

Conclusions: Procalcitonin-guided antimicrobial escalation in the intensive care unit did not improve survival and did lead to organ-related harm and prolonged admission to the intensive care unit. The procalcitonin strategy like the one used in this trial cannot be recommended.

© 2011 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins

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