Department of Cardiology, The Heart Centre, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 2142, Copenhagen, DK-2100, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Trials. 2024 Oct 30;25(1):731. doi: 10.1186/s13063-024-08567-y.
Cardiogenic shock (CS) occurs in 5-10% of patients with acute myocardial infarction (AMI), and the condition is associated with a 30-day mortality rate of up to 50%. Most of the AMI patients are in SCAI SHOCK stage B upon hospital arrival, but some of these patients will progression through the stages to overt shock (SCAI C-E). Around one third of patients who develop CS are not in shock at the time of hospital admission. Pro-B-type natriuretic peptide (proband) is a biomarker closely related to CS development. The aim of this study is to investigate the potential for preventing progression of hemodynamic instability by early inotropic support with low-dose dobutamine infusion administrated after revascularization in AMI patients with intermediate to high risk of in-hospital CS development.
This investigator-initiated, double-blinded, placebo-controlled, randomized, single-center, clinical trial will include 100 AMI patients (≥ 18 years) without CS at hospital admission and at intermediate-high risk of in-hospital CS development (ORBI risk score ≥ 10). Patients will be randomized in a 1:1 ratio to a 24 h intravenous (IV) infusion of dobutamine (5 μg/kg/min) or placebo (NaCl) administrated after acute percutaneous coronary intervention (PCI) (< 24 h from symptom onset). Blood samples are drawn at time points from study inclusion (before infusion, 12, 24, 36, and 48 h). The primary outcome is peak plasma proBNP within 48 h after infusion as a surrogate-measure for the hemodynamic status. Hemodynamic function will be assessed pulse rate, blood pressure, and lactate within 48 h after infusion and by transthoracic echocardiography (TTE) performed after 24-48 h and at follow-up after 3 months. Markers of cardiac injury (troponin T and creatine kinase MB (CK-MB)) will be assessed.
Early inotropic support with low-dose dobutamine infusion in patients with AMI, treated with acute PCI, and at intermediate-high risk of in-hospital CS may serve as an intervention promoting hemodynamic stability and facilitating patient recovery. The effect will be assessed using proBNP as a surrogate marker of CS development, hemodynamic measurements, and TTE within the initial 48 h and repeated at a 3-month follow-up.
The Regional Ethics Committee : H-21045751. EudraCT: 2021-002028-19.
gov: NCT05350592, Registration date: 2022-03-08. WHO Universal Trial Number: U1111-1277-8523.
心源性休克（CS）发生在急性心肌梗死（AMI）患者的 5-10%中，该病症与高达 50%的 30 天死亡率相关。大多数 AMI 患者在入院时处于 SCAI SHOCK 阶段 B，但其中一些患者将通过阶段进展为明显休克（SCAI C-E）。约三分之一发展为 CS 的患者在入院时并未休克。Pro-B 型利钠肽（proBNP）是一种与 CS 发展密切相关的生物标志物。本研究旨在通过在有 AMI 且有发生院内 CS 高风险的患者中，在血运重建后早期给予小剂量多巴酚丁胺输注进行正性肌力支持，以预防血流动力学不稳定的进展。
这是一项由研究者发起的、双盲、安慰剂对照、随机、单中心、临床试验，纳入了 100 例入院时无 CS 且有发生院内 CS 高风险的 AMI 患者（≥18 岁）（ORBI 风险评分≥10）。患者将以 1:1 的比例随机分为接受多巴酚丁胺（5μg/kg/min）或安慰剂（NaCl）的 24 小时静脉输注（IV），输注时间为急性经皮冠状动脉介入治疗（PCI）后（症状发作后<24 小时）。在研究纳入时（输注前、12、24、36 和 48 小时）抽取血样。主要终点是输注后 48 小时内的血浆 proBNP 峰值，作为血流动力学状态的替代指标。输注后 48 小时内通过脉搏率、血压和乳酸进行血流动力学功能评估，并在输注后 24-48 小时和 3 个月时进行经胸超声心动图（TTE）检查。还将评估心脏损伤标志物（肌钙蛋白 T 和肌酸激酶 MB（CK-MB））。
对于接受急性 PCI 治疗且有发生院内 CS 高风险的 AMI 患者，给予小剂量多巴酚丁胺输注的早期正性肌力支持可能作为一种促进血流动力学稳定和促进患者康复的干预措施。通过使用 proBNP 作为 CS 发展的替代标志物、血流动力学测量和输注后最初 48 小时内的 TTE 进行评估，将评估其效果，并在 3 个月的随访时重复评估。
区域伦理委员会：H-21045751。EudraCT：2021-002028-19。临床试验.gov：NCT05350592，注册日期：2022-03-08。世界卫生组织通用试验编号：U1111-1277-8523。
