Henry S. Sacks, PhD, MD
Does adding procalcitonin (PCT)-guided therapy to guideline-based standard care reduce mortality in critically ill patients?
Randomized controlled trial (Procalcitonin And Survival Study [PASS]). ClinicalTrials.gov NCT00271752.
28 days for primary outcome.
9 multidisciplinary intensive care units (ICUs) in regional, tertiary care, public university hospitals in Denmark.
1200 patients ≥ 18 years of age (median age 67 y, 55% men) who were enrolled ≤ 24 hours after ICU admission and had an expected ICU stay ≥ 24 hours. Exclusion criteria were bilirubin level > 684 µmol/L (40 mg/dL), triglyceride level > 11.3 mmol/L (1000 mg/dL), pregnancy, or expectation of increased risk for harm from blood sampling.
PCT-guided therapy plus guideline-based standard care (n = 604) or guideline-based standard care (n = 596). PCT-guided therapy included expanding the spectrum of antimicrobial therapy and intensifying diagnostics to identify uncontrolled infection sources when PCT level was ≥ 1.0 ng/mL at baseline or daily PCT level was ≥ 1.0 ng/mL without a ≥ 10% decrease from the previous day.
28-day mortality. Other outcomes included length of ICU stay, use of mechanical ventilation, number of antibiotics used, and renal dysfunction (estimated glomerular filtration rate < 60 mL/min/1.73 m2).
100% for mortality (intention-to-treat analysis).
Adding PCT-guided therapy to standard care did not reduce 28-day mortality or proportion of patients with renal dysfunction at discharge or death (Table). Patients in the PCT-guided group had longer stays in the ICU (median 6 vs 5 d, P = 0.004), and while in the ICU, more days on mechanical ventilation (66% vs 61%; difference 4.9%, 95% CI 3.0 to 6.7) and more days with renal dysfunction (51% vs 46%; difference 5.0%, CI 3.0 to 6.9) than those in the standard care group. The PCT-guided group also had a higher proportion of ICU days on which they received ≥ 3 antimicrobials (66% vs 58%, P = 0.002).
In critically ill patients, adding procalcitonin-guided therapy to guideline-based standard care was not associated with demonstrable patient benefit.
†EGFR = estimated glomerular filtration rate; other abbreviations defined in Glossary. RRR, RRI, and CI calculated from data in article.
Sacks HS. Adding procalcitonin-guided therapy to standard care did not reduce mortality in critically ill patients. Ann Intern Med. ;156:JC2–6. doi: 10.7326/0003-4819-156-4-201202210-02006
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Published: Ann Intern Med. 2012;156(4):JC2-6.
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