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Design and Rationale of the Sevoflurane for Sedation in Acute Respiratory Distress Syndrome (SESAR) Randomized Controlled Trial.
Blondonnet, Raiko; Simand, Laure-Anne; Vidal, Perine; Borao, Lucile; Bourguignon, Nathalie; Morand, Dominique; Bernard, Lise; Roszyk, Laurence; Audard, Jules; Godet, Thomas; Monsel, Antoine; Garnier, Marc; Quesnel, Christophe; Bazin, Jean-Etienne; Sapin, Vincent; Bastarache, Julie A; Ware, Lorraine B; Hughes, Christopher G; Pandharipande, Pratik P; Ely, E Wesley; Futier, Emmanuel; Pereira, Bruno; Constantin, Jean-Michel; Jabaudon, Matthieu.
  • Blondonnet R; Department of Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Simand LA; iGReD, Université Clermont Auvergne, CNRS, INSERM, 63000 Clermont-Ferrand, France.
  • Vidal P; Department of Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Borao L; Department of Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Bourguignon N; Department of Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Morand D; Department of Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Bernard L; Department of Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Roszyk L; Department of Clinical Research and Temporary Authorization, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Audard J; iGReD, Université Clermont Auvergne, CNRS, INSERM, 63000 Clermont-Ferrand, France.
  • Godet T; Department of Medical Biochemistry and Molecular Genetics, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Monsel A; Department of Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Garnier M; Department of Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Quesnel C; Department of Anesthesiology and Critical Care, GRC 29, DMU DREAM, Pitié-Salpêtrière Hospital, Sorbonne University, Assistance Publique-Hôpitaux de Paris, 75013 Paris, France.
  • Bazin JE; Department of Anesthesiology and Critical Care Medicine, DMU DREAM, Saint-Antoine University Hospital, Sorbonne University, Assistance Publique-Hôpitaux de Paris, 75012 Paris, France.
  • Sapin V; Department of Anesthesiology and Critical Care Medicine, DMU DREAM, Tenon University Hospital, Sorbonne University, Assistance Publique-Hôpitaux de Paris, 75020 Paris, France.
  • Bastarache JA; Department of Perioperative Medicine, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Ware LB; iGReD, Université Clermont Auvergne, CNRS, INSERM, 63000 Clermont-Ferrand, France.
  • Hughes CG; Department of Medical Biochemistry and Molecular Genetics, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
  • Pandharipande PP; Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN 37232, USA.
  • Ely EW; Department of Cell and Developmental Biology, Vanderbilt University, Nashville, TN 37232, USA.
  • Futier E; Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, TN 37232, USA.
  • Pereira B; Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN 37232, USA.
  • Constantin JM; Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, TN 37232, USA.
  • Jabaudon M; Division of Anesthesiology Critical Care Medicine, Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN 37232, USA.
  • On Behalf Of The Sesar Collaborative Group; Critical Illness, Brain Dysfunction, and Survivorship Center, Vanderbilt University Medical Center, Nashville, TN 37203, USA.
J Clin Med ; 11(10)2022 May 16.
Article in English | MEDLINE | ID: covidwho-1872095
ABSTRACT
Preclinical studies have shown that volatile anesthetics may have beneficial effects on injured lungs, and pilot clinical data support improved arterial oxygenation, attenuated inflammation, and decreased lung epithelial injury in patients with acute respiratory distress syndrome (ARDS) receiving inhaled sevoflurane compared to intravenous midazolam. Whether sevoflurane is effective in improving clinical outcomes among patients with ARDS is unknown, and the benefits and risks of inhaled sedation in ARDS require further evaluation. Here, we describe the SESAR (Sevoflurane for Sedation in ARDS) trial designed to address this question. SESAR is a two-arm, investigator-initiated, multicenter, prospective, randomized, stratified, parallel-group clinical trial with blinded outcome assessment designed to test the efficacy of sedation with sevoflurane compared to intravenous propofol in patients with moderate to severe ARDS. The primary outcome is the number of days alive and off the ventilator at 28 days, considering death as a competing event, and the key secondary outcome is 90 day survival. The planned enrollment is 700 adult participants at 37 French academic and non-academic centers. Safety and long-term outcomes will be evaluated, and biomarker measurements will help better understand mechanisms of action. The trial is funded by the French Ministry of Health, the European Society of Anaesthesiology, and Sedana Medical.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Year: 2022 Document Type: Article Affiliation country: Jcm11102796

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Language: English Year: 2022 Document Type: Article Affiliation country: Jcm11102796