Pansiritanachot Wasin, Vathanavalun Orapim, Chakorn Tipa
Department of Emergency Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Siriraj, Bangkoknoi, Bangkok 10700, Thailand.
Resusc Plus. 2024 Jan 23;17:100551. doi: 10.1016/j.resplu.2024.100551. eCollection 2024 Mar.
Post-resuscitation shock is the main cause of early death in post-cardiac arrest patients. To date, no randomized trial compares the efficacy between norepinephrine and epinephrine in post-resuscitation shock patients.
This study aimed to assess the feasibility of the study protocol, and explore potential differences in efficacy and adverse events between norepinephrine and epinephrine in post-resuscitation shock patients.
This single-center, parallel-group, open-label, feasibility randomized controlled trial included adult non-traumatic cardiac arrest patients who had post-resuscitation shock within one hour after successful resuscitation. Patients were randomized to receive norepinephrine or epinephrine in a 1:1 ratio. Feasibility outcomes were reported descriptively and narratively. Exploratory analyses were performed to compare the efficacy and adverse events.
A total of 40 patients were equally allocated. Most feasibility goals were achieved. All patients received the allocated intervention with no withdrawals. Ten (50%) patients in the norepinephrine group and 15 (75%) patients in the epinephrine group achieved the target blood pressure by the protocol with a median time of 42 and 39 min, respectively. However, the protocol deviated in 10 (25%) patients and the recruitment rate did not reach the acceptable threshold. The vasopressor dose to achieve the target blood pressure was significantly lower in the norepinephrine group. No significant differences in mortality rates and adverse outcomes were observed in the exploratory analyses.
It is feasible to conduct the definitive trial comparing early post-resuscitation outcomes in patients receiving NE versus EPI for post-resuscitation shock. Some protocol modifications are necessary.
复苏后休克是心脏骤停患者早期死亡的主要原因。迄今为止，尚无随机试验比较去甲肾上腺素和肾上腺素对复苏后休克患者的疗效。
本研究旨在评估研究方案的可行性，并探讨去甲肾上腺素和肾上腺素对复苏后休克患者疗效和不良事件的潜在差异。
这项单中心、平行组、开放标签的可行性随机对照试验纳入了成年非创伤性心脏骤停患者，这些患者在成功复苏后1小时内出现复苏后休克。患者按1:1的比例随机接受去甲肾上腺素或肾上腺素治疗。对可行性结果进行描述性和叙述性报告。进行探索性分析以比较疗效和不良事件。
共纳入40例患者，平均分配。大多数可行性目标得以实现。所有患者均接受了分配的干预，无退出者。去甲肾上腺素组10例（50%）患者和肾上腺素组15例（75%）患者按照方案达到目标血压，中位时间分别为42分钟和39分钟。然而，10例（25%）患者出现方案偏离，招募率未达到可接受阈值。去甲肾上腺素组达到目标血压的血管升压药剂量显著更低。探索性分析未观察到死亡率和不良结局的显著差异。
对接受去甲肾上腺素与肾上腺素治疗复苏后休克的患者进行比较早期复苏后结局的确定性试验是可行的。有必要对方案进行一些修改。
