Risk, rate or rhythm control for new onset supraventricular arrhythmia during septic shock: protocol for the CAFS multicentre, parallel-group, open-label trial Article Swipe
Vincent Labbé
,
Cyrielle Desnos
,
Sébastien Préau
,
Denis Doyen
,
Damien Contou
,
François Bagate
,
Bertrand Souweine
,
Vincent Pey
,
Pierre-Marie Bertrand
,
Grégoire Müller
,
Florence Boissier
,
Pierre Asfar
,
Nicolas Bonnet
,
Jérémie Joffre
,
Oumar Sy
,
Martin Dres
,
Filippo Annoni
,
Xavier Monnet
,
Serge Carreira
,
Emmanuel Vivier
,
Nicolas Serck
,
Adil Wiart
,
Sébastian Voicu
,
Nicholas Heming
,
Camille Le Breton
,
Guillaume Chevrel
,
Frank Chemouni
,
Michaël Piagnerelli
,
Lionel Haentjens
,
Muriel Fartoukh
,
Fabio Taccone
,
D. Durand
,
Gladys Monthieux
,
Laurence Bérard
,
Alexandra Rousseau
,
Armand Mekontso Dessap
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2024-090404
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2024-090404
Introduction New-onset supraventricular arrhythmia (NOSVA) is the most common arrhythmia in patients with septic shock and is associated with haemodynamic alterations and increased mortality rates. With no data available from randomised trials, clinical practice for patient management varies widely. In this setting, rate control or rhythm control could be beneficial in limiting the duration of shock and preventing evolution to multiorgan dysfunction. Methods and analysis The Control Atrial Fibrillation in Septic shock (CAFS) study is a binational (French and Belgium), multicentre, parallel-group, open-label, randomised controlled superiority trial to compare the efficacy and safety of three management strategies in patients with NOSVA during septic shock. The expected duration of patient enrolment is 42 months, starting from November 2021. Patients will be randomised to receive either risk control (magnesium and control of risk factors for NOSVA), rate control (risk control and low dose of amiodarone) or rhythm control (risk control and cardioversion using high dose of amiodarone with external electrical shock if NOSVA persists) for 7 days. Patients with a history of SVA, NOSVA lasting more than 48 hours, recent cardiac surgery or a contraindication to amiodarone will not be included. We plan to recruit 240 patients. Patients will be randomised on a 1:1:1 basis and stratified by centre. The primary endpoint is a hierarchical criterion at day 28 including all-cause mortality and the duration of septic shock defined as time from randomisation to successful weaning of vasopressors. Secondary outcomes include: individual components of the primary endpoint; arterial lactate clearance at day 3; efficacy at controlling cardiac rhythm at day 7; proportion of patients free from organ dysfunction at day 7; ventricular arrhythmia, conduction disorders, thrombotic events, major bleeding events and acute hepatitis related to amiodarone at day 28; intensive care unit and hospital lengths of stay at day 28. Ethics and dissemination The study has been approved by the French (Comité Sud-Ouest et Outre-Mer II, France, registration number 2019-A02624-53) and Belgian (Comité éthique de l’hôpital Erasme, Belgium, registration number CCB B4062023000179) ethics committees. Patients will be included after obtaining signed informed consent. The results will be submitted for publication in peer-reviewed journals. Trial registration number NCT04844801 .
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/bmjopen-2024-090404
- OA Status
- gold
- Cited By
- 1
- References
- 23
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4409058186
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4409058186Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1136/bmjopen-2024-090404Digital Object Identifier
- Title
-
Risk, rate or rhythm control for new onset supraventricular arrhythmia during septic shock: protocol for the CAFS multicentre, parallel-group, open-label trialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2025Year of publication
- Publication date
-
2025-04-01Full publication date if available
- Authors
-
Vincent Labbé, Cyrielle Desnos, Sébastien Préau, Denis Doyen, Damien Contou, François Bagate, Bertrand Souweine, Vincent Pey, Pierre-Marie Bertrand, Grégoire Müller, Florence Boissier, Pierre Asfar, Nicolas Bonnet, Jérémie Joffre, Oumar Sy, Martin Dres, Filippo Annoni, Xavier Monnet, Serge Carreira, Emmanuel Vivier, Nicolas Serck, Adil Wiart, Sébastian Voicu, Nicholas Heming, Camille Le Breton, Guillaume Chevrel, Frank Chemouni, Michaël Piagnerelli, Lionel Haentjens, Muriel Fartoukh, Fabio Taccone, D. Durand, Gladys Monthieux, Laurence Bérard, Alexandra Rousseau, Armand Mekontso DessapList of authors in order
- Landing page
-
https://doi.org/10.1136/bmjopen-2024-090404Publisher landing page
- Open access
-
YesWhether a free full text is available
- OA status
-
goldOpen access status per OpenAlex
- OA URL
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https://doi.org/10.1136/bmjopen-2024-090404Direct OA link when available
- Concepts
-
Medicine, Amiodarone, Septic shock, Clinical endpoint, Atrial fibrillation, Cardioversion, Shock (circulatory), Sinus rhythm, Randomized controlled trial, Cardiology, Internal medicine, Anesthesia, SepsisTop concepts (fields/topics) attached by OpenAlex
- Cited by
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1Total citation count in OpenAlex
- Citations by year (recent)
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2025: 1Per-year citation counts (last 5 years)
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23Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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