Vignon Philippe, Léger Julie, Evrard Bruno, Goudelin Marine, Vaidie Julien, Brit Samia, Giraudeau Bruno
Medical-surgical ICU, Dupuytren Teaching Hospital, Limoges, France
Faculty of Medicine, Limoges University, Limoges, France.
BMJ Open. 2025 Jun 30;15(6):e101200. doi: 10.1136/bmjopen-2025-101200.
Sepsis-induced left ventricular (LV) dysfunction participates in cardiovascular dysfunction and associated organ failure in patients with septic shock. The tested hypothesis is that dobutamine will reduce tissue hypoperfusion and secondary organ dysfunction in increasing oxygen delivery in fluid-filled patients with septic shock and associated symptomatic septic cardiomyopathy with documented low-flow state.
ADAPT-Dobutamine is a blinded, two parallel group, add-on, multicentre, randomised 1:1 and placebo-controlled trial. Patients will be included if hospitalised in the intensive care unit with septic shock (Sepsis-3 definition) and septic cardiomyopathy, identified using echocardiography (LV ejection fraction ≤40% and LV outflow tract velocity-time integral <14±1.5 cm). Non-inclusion criteria will include ventricular rate >130 bpm, severe ventricular arrhythmia, obstructive cardiomyopathy, severe aortic stenosis, ongoing acute coronary syndrome and indication for extracorporeal life support. Primary outcome will be the evolution of a modified Sequential Organ Failure Assessment score (excluding the neurologic system) during the initial intensive care unit stay encompassing screening (before randomisation), and from Day 1 to 3 after randomisation. Randomisation will be stratified on participating centres and previously documented heart failure (ejection fraction ≤40%). The use of open-labelled Dobutamine as a rescue therapy will be allowed in refractory shock based on strict clinical requirements. The use of alternative inotropes will not be allowed.
Approved by from Lille (France) on 19 December 2019 (approval reference #19.04.05.36321). The results will be published in a peer-reviewed journal and presented in various congresses.
NCT04166331.
脓毒症诱导的左心室功能障碍参与脓毒性休克患者的心血管功能障碍及相关器官衰竭。所验证的假设是，多巴酚丁胺将减少液体复苏后仍存在组织低灌注及继发性器官功能障碍的脓毒性休克和伴有记录在案的低流量状态的症状性脓毒症性心肌病患者的组织低灌注和继发性器官功能障碍，增加氧输送。
ADAPT - 多巴酚丁胺试验是一项双盲、两组平行、附加、多中心、1:1随机且安慰剂对照试验。如果患者因脓毒性休克（脓毒症 - 3定义）和脓毒症性心肌病入住重症监护病房，且经超声心动图确诊（左心室射血分数≤40%且左心室流出道速度时间积分<14±1.5 cm），则纳入研究。排除标准包括心室率>130次/分、严重室性心律失常、梗阻性心肌病、严重主动脉瓣狭窄、正在发作的急性冠状动脉综合征以及体外生命支持指征。主要结局将是在初始重症监护病房住院期间（包括筛查期[随机分组前]以及随机分组后第1天至第3天）改良的序贯器官衰竭评估评分（不包括神经系统）的变化。随机分组将根据参与中心及先前记录的心力衰竭情况（射血分数≤40%）进行分层。基于严格的临床要求，难治性休克患者允许使用开放标签的多巴酚丁胺作为挽救治疗。不允许使用其他血管活性药物。
2019年12月19日获法国里尔批准（批准文号#19.04.05.36321）。研究结果将发表在同行评审期刊上，并在各类大会上报告。
NCT04166331。
