Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1 (AdrenOSS-1) study.
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Ошибки и ограничения
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Mebazaa Alexandre, Geven Christopher, Hollinger Alexa, Wittebole Xavier, Chousterman Benjamin Glen, Blet Alice, Gayat Etienne, Hartmann Oliver, Scigalla Paul, Struck Joachim, Bergmann Andreas, Antonelli Massimo, Beishuizen Albertus, Constantin Jean-Michel, Damoisel Charles, Deye Nicolas, Di Somma Salvatore, Dugernier Thierry, François Bruno, Gaudry Stephane, Huberlant Vincent, Lascarrou Jean-Baptiste, Marx Gernot, Mercier Emmanuelle, Oueslati Haikel, Pickkers Peter, Sonneville Romain, Legrand Matthieu, Laterre Pierre-François, AdrenOSS-1 study investigators
Аннотация
METHODS: AdrenOSS-1 was a prospective observational multinational study. The primary outcome was 28-day mortality. Secondary outcomes included organ failure as defined by Sequential Organ Failure Assessment (SOFA) score, organ support with focus on vasopressor/inotropic use, and need for renal replacement therapy. AdrenOSS-1 included 583 patients admitted to the ICU with sepsis or septic shock.
RESULTS: Circulating bio-ADM levels were measured upon admission and at day 2. Median bio-ADM concentration upon admission was 80.5 pg/ml [IQR 41.5-148.1 pg/ml]. Initial SOFA score was 7 [IQR 5-10], and 28-day mortality was 22%. We found marked associations between bio-ADM upon admission and 28-day mortality (unadjusted standardized HR 2.3 [CI 1.9-2.9]; adjusted HR 1.6 [CI 1.1-2.5]) and between bio-ADM levels and SOFA score (p < 0.0001). Need of vasopressor/inotrope, renal replacement therapy, and positive fluid balance were more prevalent in patients with a bio-ADM > 70 pg/ml upon admission than in those with bio-ADM ≤ 70 pg/ml. In patients with bio-ADM > 70 pg/ml upon admission, decrease in bio-ADM below 70 pg/ml at day 2 was associated with recovery of organ function at day 7 and better 28-day outcome (9.5% mortality). By contrast, persistently elevated bio-ADM at day 2 was associated with prolonged organ dysfunction and high 28-day mortality (38.1% mortality, HR 4.9, 95% CI 2.5-9.8).
CONCLUSIONS: AdrenOSS-1 shows that early levels and rapid changes in bio-ADM estimate short-term outcome in sepsis and septic shock. These data are the backbone of the design of the biomarker-guided AdrenOSS-2 trial.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT02393781 . Registered on March 19, 2015.