Anaesthesia and Intensive Care, 1st Medical Faculty, Charles University and General University Hospital in Prague, Prague, Czech Republic, EU
Anaesthesia and Intensive Care, 3rd Medical Faculty, Charles University and Kralovske Vinohrady University Hospital in Prague, Prague, Czech Republic, EU.
BMJ Open. 2019 Sep 3;9(9):e031678. doi: 10.1136/bmjopen-2019-031678.
Supraventricular arrhythmias contribute to haemodynamic compromise in septic shock. A retrospective study generated the hypothesis that propafenone could be more effective than amiodarone in achieving and maintaining sinus rhythm (SR). Certain echocardiographic parameters may predict a successful cardioversion and help in the decision on rhythm or rate control strategy.
The trial includes septic shock patients with new-onset arrhythmia, but without severe impairment of the left ventricular ejection fraction. After baseline echocardiography, the patient is randomised to receive a bolus and maintenance dose of either amiodarone or propafenone. The primary outcome is the proportion of patients that have achieved rhythm control at 24 hours after the start of the infusion. The secondary outcomes are the percentages of patients that needed rescue treatments (DC cardioversion or unblinding and crossover of the antiarrhythmics), the recurrence of arrhythmias, intensive care unit mortality, 28-day and 1-year mortality. In the posthoc analysis, we separately assess subgroups of patients with pulmonary hypertension and right ventricular dysfunction. In the exploratory part of the study, we assess whether the presence of a transmitral diastolic A wave and its higher velocity-time integral is predictive for the sustainability of mechanical SR and whether the indexed left atrial endsystolic volume is predictive of recurrent arrhythmia. Considering that the restoration of SR within 24 hours occurred in 74% of the amiodarone-treated patients and in 89% of the patients treated with propafenone, we plan to include 200 patients to have an 80% chance to demonstrate the superiority of propafenone at p=0.05.
The trial is recruiting patients according to its second protocol version approved by the University Hospital Ethical Board on the 6 October 2017 (No. 1691/16S-IV). The results will be disseminated through peer reviewed publications and conference presentations.
NCT03029169.
室上性心律失常会导致感染性休克患者出现血液动力学不稳定。一项回顾性研究提出了这样一个假设，即普罗帕酮在恢复窦性心律（SR）方面可能比胺碘酮更有效。某些超声心动图参数可以预测电复律的成功，并有助于决定节律或心率控制策略。
本试验纳入了新发心律失常但左心室射血分数无严重受损的感染性休克患者。在基线超声心动图检查后，患者随机接受胺碘酮或普罗帕酮的推注和维持剂量。主要终点是在输液开始后 24 小时达到节律控制的患者比例。次要终点是需要抢救治疗（直流电复律或抗心律失常药物的揭盲和交叉）的患者比例、心律失常复发率、重症监护病房死亡率、28 天和 1 年死亡率。在事后分析中，我们分别评估了伴有肺动脉高压和右心室功能障碍的患者亚组。在研究的探索性部分，我们评估了是否存在经二尖瓣舒张 A 波及其更高的速度-时间积分可预测机械性 SR 的可持续性，以及左心房收缩末期容积指数是否可预测心律失常复发。考虑到在胺碘酮治疗的患者中有 74%和普罗帕酮治疗的患者中有 89%在 24 小时内恢复了 SR，我们计划纳入 200 名患者，以 80%的把握度在 p=0.05 时证明普罗帕酮的优越性。
该试验根据 2017 年 10 月 6 日大学医院伦理委员会批准的第二版方案（第 1691/16S-IV 号）正在招募患者。研究结果将通过同行评议的出版物和会议报告进行传播。
NCT03029169。
