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Protocol for fever control using external cooling in mechanically ventilated patients with septic shock: SEPSISCOOL II randomised controlled trial.
Guénégou-Arnoux, Armelle; Murris, Juliette; Bechet, Stéphane; Jung, Camille; Auchabie, Johann; Dupeyrat, Julien; Anguel, Nadia; Asfar, Pierre; Badie, Julio; Carpentier, Dorothée; Chousterman, Benjamin; Bourenne, Jeremy; Delbove, Agathe; Devaquet, Jérôme; Deye, Nicolas; Dumas, Guillaume; Dureau, Anne-Florence; Lascarrou, Jean-Baptiste; Legriel, Stephane; Guitton, Christophe; Jannière-Nartey, Caroline; Quenot, Jean-Pierre; Lacherade, Jean-Claude; Maizel, Julien; Mekontso Dessap, Armand; Mourvillier, Bruno; Petua, Philippe; Plantefeve, Gaetan; Richard, Jean-Christophe; Robert, Alexandre; Saccheri, Clément; Vong, Ly Van Phach; Katsahian, Sandrine; Schortgen, Frédérique.
Afiliación
  • Guénégou-Arnoux A; INSERM CIC1418-EC, INSERM-INRIA HeKA, Université Paris Cité, Paris, France armelle.arnoux@aphp.fr.
  • Murris J; Hôpital européen Georges Pompidou, Unité de Recherche Clinique, AP-HP, Paris, France.
  • Bechet S; INSERM-INRIA HeKA, Université Paris Cité, Paris, France.
  • Jung C; RWE & Data, Pierre Fabre SA, Paris, France.
  • Auchabie J; Association ACTIV, Créteil, France.
  • Dupeyrat J; Centre Hospitalier Intercommunal de Créteil, Creteil, France.
  • Anguel N; Centre Hospitalier de Cholet, Cholet, France.
  • Asfar P; Centre Hospitalier de Cholet, Cholet, France.
  • Badie J; ICU Medical, AP-HP, Hôpital du Kremlin Bicêtre, Le Kremlin-Bicètre, France.
  • Carpentier D; Centre Hospitalier Universitaire d'Angers, Angers, France.
  • Chousterman B; Hôpital Nord Franche-Comté - Site de Belfort, Belfort, France.
  • Bourenne J; Centre Hospitalier Universitaire de Rouen, Rouen, France.
  • Delbove A; Hôpital Lariboisière, Paris, France.
  • Devaquet J; Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, CHU La Timone 2, Marseille, France.
  • Deye N; Réanimation Polyvalente, Centre Hospitalier Bretagne Atlantique, Vannes, France.
  • Dumas G; Medical-Surgical Intensive Care Unit, Hôpital Foch, Suresnes, France.
  • Dureau AF; Réanimation Médicale et Toxicologique, AP-HP, INSERM UMR-S 942, Hopital Lariboisiere, Paris, France.
  • Lascarrou JB; Intensive Care Medicine, Hôpital Albert Michallon, La Tronche, France.
  • Legriel S; Groupe Hospitalier Régional Mulhouse Sud Alsace, Mulhouse, France.
  • Guitton C; Service de Médecine Intensive Réanimation, CHU Nantes, Nantes, France.
  • Jannière-Nartey C; Intensive Care Unit, Centre Hospitalier de Versailles, Le Chesnay, France.
  • Quenot JP; Médecine intensive réanimation, Centre Hospitalier de Mans, Le Mans, France.
  • Lacherade JC; Centre Hospitalier de Libourne, Libourne, France.
  • Maizel J; Réanimation médicale, CHU Dijon, Dijon, France.
  • Mekontso Dessap A; Medical-Surgical Intensive Care Unit, Centre Hospitalier Departmental La Roche-sur-Yon, La Roche-sur-Yon, France.
  • Mourvillier B; Service de Médecine Intensive Réanimation, Centre Hospitalier Universitaire Amiens-Picardie, Amiens, France.
  • Petua P; Médecine Intensive Réanimation, Hôpitaux Universitaires Henri Mondor, Créteil, France.
  • Plantefeve G; Centre Hospitalier Universitaire de Reims, Reims, France.
  • Richard JC; Centre Hospitalier de Tarbes, Tarbes, France.
  • Robert A; Service de Médecine Intensive Réanimation, Centre Hospitalier d'Argenteuil, Argenteuil, France.
  • Saccheri C; Université de Lyon, Lyon, France.
  • Vong LVP; Pasteur 2 Medical ICU, Centre Hospitalier Universitaire de Nice Hôpital Pasteur, Nice, France.
  • Katsahian S; Medical ICU, Centre Hospitalier Universitaire de Nice, Nice, France.
  • Schortgen F; Groupe Hospitalier Est Francilien, Jossigny, France.
BMJ Open ; 14(1): e069430, 2024 01 29.
Article en En | MEDLINE | ID: mdl-38286691
ABSTRACT

INTRODUCTION:

Fever treatment is commonly applied in patients with sepsis but its impact on survival remains undetermined. Patients with respiratory and haemodynamic failure are at the highest risk for not tolerating the metabolic cost of fever. However, fever can help to control infection. Treating fever with paracetamol has been shown to be less effective than cooling. In the SEPSISCOOL pilot study, active fever control by external cooling improved organ failure recovery and early survival. The main objective of this confirmatory trial is to assess whether fever control at normothermia can improve the evolution of organ failure and mortality at day 60 of febrile patients with septic shock. This study will compare two strategies within the first 48 hours of septic shock treatment of fever with cooling or no treatment of fever. METHODS AND

ANALYSIS:

SEPSISCOOL II is a pragmatic, investigator-initiated, adaptive, multicentre, open-label, randomised controlled, superiority trial in patients admitted to the intensive care unit with febrile septic shock. After stratification based on the acute respiratory distress syndrome status, patients will be randomised between two arms (1) cooling and (2) no cooling. The primary endpoint is mortality at day 60 after randomisation. The secondary endpoints include the evolution of organ failure, early mortality and tolerance. The target sample size is 820 patients. ETHICS AND DISSEMINATION The study is funded by the French health ministry and was approved by the ethics committee CPP Nord Ouest II (Amiens, France). The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT04494074.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Choque Séptico / Sepsis Tipo de estudio: Clinical_trials Aspecto: Ethics Límite: Humans Idioma: En Revista: BMJ Open Año: 2024 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Choque Séptico / Sepsis Tipo de estudio: Clinical_trials Aspecto: Ethics Límite: Humans Idioma: En Revista: BMJ Open Año: 2024 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido