A Multinational Randomized Trial of Mega-Dose Esomeprazole as Anti-Inflammatory Agent in Sepsis.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Monti Giacomo, Carta Sonia, Kotani Yuki, Bruni Andrea, Konkayeva Maiya, Guarracino Fabio, Yakovlev Aleksey, Cucciolini Giada, Shemetova Maria, Scapol Sara, Momesso Elena, Garofalo Eugenio, Brizzi Giulia, Baldassarri Rubia, Ajello Silvia, Isirdi Alessandro, Meroi Francesco, Baiardo Redaelli Martina, Boffa Nicoletta, Votta Carmine Domenico, Borghi Giovanni, Montrucchio Giorgia, Rauch Simon, D'Amico Filippo, Pace Maria Caterina, Paternoster Gianluca, Vitale Francesca, Giardina Giuseppe, Labanca Rosa, Lembo Rosalba, Marmiere Marilena, Marzaroli Matteo, Nakhnoukh Cristina, Plumari Valentina, Scandroglio Anna Mara, Scquizzato Tommaso, Sordoni Stella, Valsecchi Davide, Agrò Felice Eugenio, Finco Gabriele, Bove Tiziana, Corradi Francesco, Likhvantsev Valery, Longhini Federico, Konkayev Aidos, Landoni Giovanni, Bellomo Rinaldo, Zangrillo Alberto, PPI-SEPSIS Study Group
Аннотация
DESIGN: A multinational, randomized, double-blind, placebo-controlled clinical trial.
SETTING: Seventeen ICUs or emergency departments in three countries.
PATIENTS: Adult patients with sepsis or septic shock.
INTERVENTIONS: Mega-dose (1024 mg) esomeprazole or placebo over a 72-hour period.
MEASUREMENTS AND MAIN RESULTS: The primary outcome was mean daily Sequential Organ Failure Assessment (SOFA) score to day 10. Secondary outcomes included antibiotics-free days, ICU-free days at day 28, and all-cause mortality. We also conducted a mechanistic study of the in vitro effects of esomeprazole in sepsis. We randomized 307 patients and assigned 148 to esomeprazole and 159 to placebo. Mean age was 71 years; 166 patients (54%) had septic shock and median SOFA score at randomization was 7. The median mean daily SOFA score in the first 10 days post-randomization was 5 (interquartile range [IQR], 3-9) in the esomeprazole group and 5 (IQR, 3-8) in the placebo group (risk difference, 0.1; 95% CI, -0.8 to 1.0; p > 0.99). No differences were observed in secondary outcomes. Monocytes isolated from patients' peripheral blood and activated with a toll-like receptor agonist exhibited a pro-inflammatory phenotype, which was not affected by esomeprazole therapy.
CONCLUSIONS: Among patients with sepsis or septic shock, mega-dose esomeprazole did not reduce organ dysfunction or other patient-related or biological secondary outcomes.