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. 2024 Jan 29;14(1):e069430.
doi: 10.1136/bmjopen-2022-069430.

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

Armelle Guénégou-Arnoux  1   2 , Juliette Murris  3   4 , Stéphane Bechet  5 , Camille Jung  6 , Johann Auchabie  7 , Julien Dupeyrat  7 , Nadia Anguel  8 , Pierre Asfar  9 , Julio Badie  10 , Dorothée Carpentier  11 , Benjamin Chousterman  12 , Jeremy Bourenne  13 , Agathe Delbove  14 , Jérôme Devaquet  15 , Nicolas Deye  16 , Guillaume Dumas  17 , Anne-Florence Dureau  18 , Jean-Baptiste Lascarrou  19 , Stephane Legriel  20 , Christophe Guitton  21 , Caroline Jannière-Nartey  22 , Jean-Pierre Quenot  23 , Jean-Claude Lacherade  24 , Julien Maizel  25 , Armand Mekontso Dessap  26 , Bruno Mourvillier  27 , Philippe Petua  28 , Gaetan Plantefeve  29 , Jean-Christophe Richard  30 , Alexandre Robert  31 , Clément Saccheri  32 , Ly Van Phach Vong  33 , Sandrine Katsahian  34   2 , Frédérique Schortgen  6 ; REVA Network
Affiliations

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

Armelle Guénégou-Arnoux et al. BMJ Open. .

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.

Keywords: adult intensive & critical care; clinical trial; intensive & critical care; statistics & research methods.

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Conflict of interest statement

Competing interests: FS is a member of the executive committee of the French Intensive Care Society (SRLF). All other authors declare no competing interests.

Figures

Figure 1
Figure 1
SEPSISCOOL-II trial design. ARDS, acute respiratory distress syndrome.
Figure 2
Figure 2
Interim analyses and rules for decision-making. See the text for the definition of conditional power. (A) Absence of the acute respiratory distress syndrome (ARDS) stratum effect; (B) effect of cooling in favour of ARDS; (C) effect of cooling in favour of no ARDS. CP, conditional power.
See this image and copyright information in PMC

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