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
Alexandre Mebazaa,
Christopher Geven,
Alexa Hollinger,
Xavier Wittebole,
Benjamin Glen Chousterman,
Alice Blet,
Etienne Gayat,
Oliver Hartmann,
Paul Scigalla,
Joachim Struck,
Andreas Bergmann,
Massimo Antonelli,
Albertus Beishuizen,
Jean-Michel Constantin,
Charles Damoisel,
Nicolas Deye,
Salvatore Di Somma,
Thierry Dugernier,
Bruno François,
Stephane Gaudry,
Vincent Huberlant,
Jean-Baptiste Lascarrou,
Gernot Marx,
Emmanuelle Mercier,
Haikel Oueslati,
Peter Pickkers,
Romain Sonneville,
Matthieu Legrand,
Pierre-François Laterre,
AdrenOSS-1 study investigators
Affiliations
Alexandre Mebazaa
Department of Anesthesiology, Burn and Critical Care Medicine, AP-HP, Saint Louis and Lariboisière University Hospitals
Christopher Geven
Department of Intensive Care Medicine, Radboud University Medical Center
Alexa Hollinger
Department of Anesthesiology, Burn and Critical Care Medicine, AP-HP, Saint Louis and Lariboisière University Hospitals
Xavier Wittebole
Department of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain
Benjamin Glen Chousterman
Department of Anesthesiology, Burn and Critical Care Medicine, AP-HP, Saint Louis and Lariboisière University Hospitals
Alice Blet
Department of Anesthesiology, Burn and Critical Care Medicine, AP-HP, Saint Louis and Lariboisière University Hospitals
Etienne Gayat
Department of Anesthesiology, Burn and Critical Care Medicine, AP-HP, Saint Louis and Lariboisière University Hospitals
Oliver Hartmann
sphingotec GmbH
Paul Scigalla
Adrenomed AG
Joachim Struck
sphingotec GmbH
Andreas Bergmann
sphingotec GmbH
Massimo Antonelli
Fondazione Policlinico Universitario A. Gemelli
Albertus Beishuizen
Department of Intensive Care, Medische Spectrum Twente
Jean-Michel Constantin
Department of Perioperative Medicine, University Hospital of Clermont-Ferrand
Charles Damoisel
Department of Anesthesiology, Burn and Critical Care Medicine, AP-HP, Saint Louis and Lariboisière University Hospitals
Nicolas Deye
Inserm 942
Salvatore Di Somma
Sant’ Andrea Hospital
Thierry Dugernier
Clinique St Pierre
Bruno François
ICU Department, CHU Dupuytren
Stephane Gaudry
Hôpital Louis Mourier
Vincent Huberlant
Hôpital Jolimont
Jean-Baptiste Lascarrou
Centre Hospitalier Universitaire de Nantes
Gernot Marx
Klinik für Operative Intensivmedizin und Intermediate Care, Universitätsklinikum der RWTH
Emmanuelle Mercier
CHU de Tours
Haikel Oueslati
Department of Anesthesiology, Burn and Critical Care Medicine, AP-HP, Saint Louis and Lariboisière University Hospitals
Peter Pickkers
Department of Intensive Care Medicine, Radboud University Medical Center
Romain Sonneville
Hopital Bichat Claude-Bernard
Matthieu Legrand
Department of Anesthesiology, Burn and Critical Care Medicine, AP-HP, Saint Louis and Lariboisière University Hospitals
Pierre-François Laterre
Department of Critical Care Medicine, Saint Luc University Hospital, Université Catholique de Louvain
Abstract Background Adrenomedullin (ADM) regulates vascular tone and endothelial permeability during sepsis. Levels of circulating biologically active ADM (bio-ADM) show an inverse relationship with blood pressure and a direct relationship with vasopressor requirement. In the present prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock 1 (, AdrenOSS-1) study, we assessed relationships between circulating bio-ADM during the initial intensive care unit (ICU) stay and short-term outcome in order to eventually design a biomarker-guided randomized controlled trial. 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 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.