Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University, 2# Anzhen Road, Chaoyang District, Beijing, 100029, China.
Trials. 2022 Aug 19;23(1):684. doi: 10.1186/s13063-022-06617-x.
In critically ill patients requiring extracorporeal membrane oxygenation (ECMO) therapy, early initiation of continuous renal replacement therapy (CRRT) and beta-blockade of catecholamine-induced inotropic effects may improve outcomes.
A 2 × 2 partial factorial randomized controlled trial in eligible ECMO patients without a clear indication or contraindication to either intervention is centrally randomly assigned to (A) early or conventional-indicated CRRT and/or (B) beta-blocker or usual care. The primary outcome is all-cause mortality at 30 days for both arms. A total of 496 participants provides 80% power to determine a 20% risk reduction in mortality at 30 days with 5% type I error.
This trial will help define the role of early CRRT and beta-blockade in ECMO patients. There have been 89 patients enrolled at 10 hospitals in study A and is ongoing. However, study B was stopped in August 2019 in the absence of any patients being enrolled.
ClinicalTrials.gov NCT03549923 . Registered on 8 June 2018. World Health Organization International Clinical Trials Registry Platform (WHO ICTEP) network. The Ethics Committee of Beijing Anzhen Hospital Approval ID is 2018013.
在需要体外膜肺氧合 (ECMO) 治疗的危重症患者中，早期开始连续肾脏替代治疗 (CRRT) 和儿茶酚胺诱导的变力作用的β受体阻滞剂治疗可能改善预后。
在没有明确的适应证或禁忌证的 ECMO 患者中，采用 2×2 部分析因随机对照试验，对患者进行中央随机分组，分别接受（A）早期或常规指示的 CRRT 和/或（B）β受体阻滞剂或常规治疗。主要结局是两组患者在 30 天时的全因死亡率。共 496 名患者可提供 80%的效能，以确定在 30 天时死亡率降低 20%，假阳性率为 5%。
本试验将有助于确定早期 CRRT 和β受体阻滞剂在 ECMO 患者中的作用。在研究 A 中，已有 89 名患者在 10 家医院入组，目前正在进行中。然而，研究 B 已于 2019 年 8 月停止，因为没有患者入组。
ClinicalTrials.gov NCT03549923。注册于 2018 年 6 月 8 日。世界卫生组织国际临床试验注册平台（WHO ICTRP）网络。北京安贞医院伦理委员会批准文号为 2018013。
