Alessandro Protti1, Serge Masson2, Roberto Latini2, Roberto Fumagalli3, Marilena Romero4, Carla Pessina5, Giovanni Pasetti6, Gianni Tognoni2, Antonio Pesenti7, Luciano Gattinoni8, Pietro Caironi9. 1. Dipartimento di Anestesia, Rianimazione ed Emergenza-Urgenza, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milan, Italy. 2. Dipartimento di Ricerca Cardiovascolare, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy. 3. Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan, Italy; Dipartimento di Scienze della Salute, Università degli Studi di Milano-Bicocca, Milan, Italy. 4. Dipartimento di Scienze Mediche, Orali e Biotecnologiche - Sezione di Farmacologia e Tossicologia, Chieti, Italy. 5. Dipartimento Gestionale Anestesia, Rianimazione e Emergenza Urgenza, Presidio di Rho, Rho (MI), Italy. 6. UOSD Anestesia e Rianimazione, Ospedale San Giovanni di Dio, Azienda Usl Toscana sud est, Orbetello (GR), Italy. 7. Dipartimento di Anestesia, Rianimazione ed Emergenza-Urgenza, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milan, Italy; Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Università degli Studi di Milano, Milan, Italy. 8. Department of Anaesthesiology, Emergency and Intensive Care Medicine, University of Göttingen, Göttingen, Germany. 9. SCDU Anestesia e Rianimazione, Azienda Ospedaliero-Universitaria S. Luigi Gonzaga, Orbassano (TO), Italy; Dipartimento di Oncologia, Università degli Studi di Torino, Turin, Italy. Electronic address: pietro.caironi@unito.it.
Abstract
BACKGROUND: Relevance of low (< 70%) central venous oxygen saturation (Scvo2) during early sepsis has been recently questioned by three negative trials (Protocol-Based Care for Early Septic Shock, Australasian Resuscitation in Sepsis Evaluation, and Protocolized Management in Sepsis) on early goal-directed therapy; however, subjects included in those trials had Scvo2 at enrollment as high as 71 ± 13%, 73 ± 11%, and 70 ± 12%. Here we assess the association between Scvo2 < 70% at 6 h and 90-day mortality in subjects enrolled in the Albumin Italian Outcome Sepsis (ALBIOS) trial, focusing on those with initial Scvo2 < 70%. METHODS: Regardless of treatment assignment (to receive albumin or not), all subjects enrolled in the ALBIOS trial received early goal-directed therapy aiming for Scvo2 ≥ 70% at 6 h. Using multivariable logistic regression analyses, we tested the association between Scvo2 < 70% at 6 h and 90-day mortality in those with initial Scvo2 < 70% (n = 514) or ≥ 70% (n = 961). RESULTS: Scvo2 < 70% at 6 h was independently associated with higher 90-day mortality in subjects with initial Scvo2 < 70% (OR, 1.84; 95% CI, 1.19-2.85; P = .007) but not in those with initial Scvo2 ≥ 70% (OR, 1.25; 95% CI, 0.79-1.95; P = .357). Scvo2 < 70% at enrollment and at 6 h was associated with history and/or signs of cardiac dysfunction but not with greater severity of disease or more aggressive resuscitation (required per protocol). CONCLUSIONS: In the ALBIOS trial, persistence of low Scvo2 was associated with higher 90-day mortality, possibly because it reflected underlying cardiac dysfunction. Subjects with Scvo2 < 70% may benefit most from individually tailored interventions aimed at normalizing the balance between systemic oxygen delivery and consumption. TRIAL REGISTRY: ClinicalTrials.gov; No. NCT00707122; URL: www.clinicaltrials.gov.
RCT Entities:
BACKGROUND: Relevance of low (< 70%) central venous oxygen saturation (Scvo2) during early sepsis has been recently questioned by three negative trials (Protocol-Based Care for Early Septic Shock, Australasian Resuscitation in Sepsis Evaluation, and Protocolized Management in Sepsis) on early goal-directed therapy; however, subjects included in those trials had Scvo2 at enrollment as high as 71 ± 13%, 73 ± 11%, and 70 ± 12%. Here we assess the association between Scvo2 < 70% at 6 h and 90-day mortality in subjects enrolled in the Albumin Italian Outcome Sepsis (ALBIOS) trial, focusing on those with initial Scvo2 < 70%. METHODS: Regardless of treatment assignment (to receive albumin or not), all subjects enrolled in the ALBIOS trial received early goal-directed therapy aiming for Scvo2 ≥ 70% at 6 h. Using multivariable logistic regression analyses, we tested the association between Scvo2 < 70% at 6 h and 90-day mortality in those with initial Scvo2 < 70% (n = 514) or ≥ 70% (n = 961). RESULTS: Scvo2 < 70% at 6 h was independently associated with higher 90-day mortality in subjects with initial Scvo2 < 70% (OR, 1.84; 95% CI, 1.19-2.85; P = .007) but not in those with initial Scvo2 ≥ 70% (OR, 1.25; 95% CI, 0.79-1.95; P = .357). Scvo2 < 70% at enrollment and at 6 h was associated with history and/or signs of cardiac dysfunction but not with greater severity of disease or more aggressive resuscitation (required per protocol). CONCLUSIONS: In the ALBIOS trial, persistence of low Scvo2 was associated with higher 90-day mortality, possibly because it reflected underlying cardiac dysfunction. Subjects with Scvo2 < 70% may benefit most from individually tailored interventions aimed at normalizing the balance between systemic oxygen delivery and consumption. TRIAL REGISTRY: ClinicalTrials.gov; No. NCT00707122; URL: www.clinicaltrials.gov.