Labbé Vincent, Desnos Cyrielle, Preau Sebastien, Doyen Denis, Contou Damien, Bagate François, Souweine Bertrand, Pey Vincent, Bertrand Pierre-Marie, Müller Grégoire, Boissier Florence, Asfar Pierre, Bonnet Nicolas, Joffre Jérémie, Sy Oumar, Dres Martin, Annoni Filippo, Monnet Xavier, Carreira Serge, Vivier Emmanuel, Serck Nicolas, Wiart Adil, Voicu Sebastian, Heming Nicholas, Le Breton Camille, Chevrel Guillaume, Chemouni Frank, Piagnerelli Michael, Haentjens Lionel, Fartoukh Muriel, Taccone Fabio, Durand Dominique, Monthieux Gladys, Berard Laurence, Rousseau Alexandra, Mekontso Dessap Armand
Department of Intensive Care, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Anderlecht, Brussels, Belgium
Institut Mondor de Recherche Biomédicale, Groupe de Recherche Clinique CARMAS (Cardiovascular and Respiratory Manifestations of Acute Lung Injury and Sepsis), Universite Paris-Est Creteil Val de Marne, Créteil, Île-de-France, France.
BMJ Open. 2025 Apr 1;15(4):e090404. doi: 10.1136/bmjopen-2024-090404.
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.
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.
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.
NCT04844801.
新发室上性心律失常（NOSVA）是感染性休克患者中最常见的心律失常，与血流动力学改变及死亡率增加相关。由于缺乏随机试验数据，患者管理的临床实践差异很大。在这种情况下，心率控制或节律控制可能有助于缩短休克持续时间并防止发展为多器官功能障碍。
感染性休克心房颤动控制（CAFS）研究是一项双边（法国和比利时）、多中心、平行组、开放标签的随机对照优效性试验，旨在比较感染性休克期间NOSVA患者三种管理策略的疗效和安全性。预计患者入组时间为42个月，从2021年11月开始。患者将被随机分配接受风险控制（镁剂及控制NOSVA的危险因素）、心率控制（风险控制及低剂量胺碘酮）或节律控制（风险控制及若NOSVA持续则使用高剂量胺碘酮并进行体外电击复律），为期7天。有室上性心律失常病史、NOSVA持续超过48小时、近期心脏手术或对胺碘酮有禁忌证的患者将不纳入。我们计划招募240名患者。患者将按1:1:1随机分组，并按中心分层。主要终点是第28天的分层标准，包括全因死亡率及感染性休克持续时间，感染性休克持续时间定义为从随机分组到成功停用血管升压药的时间。次要结局包括：主要终点的各个组成部分；第3天的动脉血乳酸清除率；第7天控制心律的疗效；第7天无器官功能障碍患者的比例；第28天与胺碘酮相关的室性心律失常、传导障碍、血栓事件、大出血事件及急性肝炎；第28天重症监护病房住院时间和医院住院时间。
该研究已获得法国（法国西南部及海外地区委员会II，注册号2019 - A02624 - 53）和比利时（比利时伊拉斯谟医院伦理委员会，注册号CCB B4062023000179）伦理委员会的批准。患者将在获得签署的知情同意书后纳入。研究结果将提交至同行评审期刊发表。
NCT04844801。
