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Article Dans Une Revue BMJ Open Année : 2024

Protocol for fever control using external cooling in mechanically ventilated patients with septic shock: SEPSISCOOL II randomised controlled trial

1 CIC 1418 - CIC - HEGP
2 Unité de Recherche Clinique et Centre Investigation Clinique-Epidémiologie
3 HeKA - Health data- and model- driven Knowledge Acquisition
4 PIERRE FABRE
5 ACTIV - Association Clinique et Thérapeutique Infantile du Val de Marne
6 CHIC - Centre Hospitalier Intercommunal de Créteil
7 CH Cholet - Centre Hospitalier de Cholet
8 Hôpital Bicêtre [AP-HP, Le Kremlin-Bicêtre]
9 CHU Angers - Centre Hospitalier Universitaire d'Angers
10 HNFC - Hôpital Nord Franche-Comté [Hôpital de Trévenans]
11 CHU Rouen
12 Hôpital Lariboisière-Fernand-Widal [APHP]
13 TIMONE - Hôpital de la Timone [CHU - APHM]
14 CHBA - Centre hospitalier Bretagne Atlantique (Morbihan)
15 Hôpital Foch [Suresnes]
16 Service de Réanimation Médicale et Toxicologique [Hôpital Lariboisière]
17 Hôpital Michallon
18 Groupe hospitalier de la région de Mulhouse et Sud-Alsace
19 CHU Nantes - Centre Hospitalier Universitaire de Nantes
20 Service de réanimation [CH Versailles]
21 Service Réanimation médico-chirurgicale [CH Le Mans]
22 Centre Hospitalier Libourne
23 CHU Dijon - Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand
24 CHD Vendée - Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
25 Médecine Intensive-Réanimation [CHU Amiens]
26 MP3CV - Mécanismes physiopathologiques et conséquences des calcifications vasculaires - UR UPJV 7517
27 CHU Henri Mondor [Créteil]
28 Hôpital universitaire Robert Debré [Reims]
29 Centre Hospitalier de Bigorre [Tarbes]
30 CH Argenteuil - Centre hospitalier Argenteuil
31 Université de Lyon
32 CHU - Hôpital Pasteur [Nice]
33 CHU Nice - Centre Hospitalier Universitaire de Nice
34 GHEF - Grand Hôpital de l'Est Francilien
35 HEGP - Hôpital Européen Georges Pompidou [APHP]
36 CRC (UMR_S_1138 / U1138) - Centre de Recherche des Cordeliers
Dorothée Carpentier
  • Fonction : Auteur
Stephane Legriel
Armand Mekontso Dessap
Gaetan Plantefeve

Résumé

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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hal-04505165 , version 1 (10-04-2024)

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Armelle Guénégou-Arnoux, Juliette Murris, Stéphane Bechet, Camille Jung, Johann Auchabie, et al.. Protocol for fever control using external cooling in mechanically ventilated patients with septic shock: SEPSISCOOL II randomised controlled trial. BMJ Open, 2024, 14 (1), pp.e069430. ⟨10.1136/bmjopen-2022-069430⟩. ⟨hal-04505165⟩
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