Chen Zheyuan, Han Xiao, Li Lingru, Liu Maomao, Yu Li, Cheng Sihao, Yu Yan, Liu Nan
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Department of Emergency, University of Health and Rehabilitation (Qingdao Municipal Hospital), Qingdao , Qingdao Hospital, 266000, China.
Trials. 2025 Aug 11;26(1):284. doi: 10.1186/s13063-025-08986-5.
Acute kidney injury (AKI) is a frequent and serious complication following surgery for acute type A aortic dissection (ATAAD). Nitric oxide (NO) may reduce AKI incidence through renal-protective mechanisms, but evidence in the ATAAD population remains limited. This trial aims to evaluate whether perioperative administration of NO can reduce the incidence of postoperative AKI in this population.
This single-center, randomized, parallel-group superiority trial will enroll 106 adult patients undergoing ATAAD emergency surgery. Participants will be randomly allocated in a 1:1 ratio to either receive 60 parts per million of NO during cardiopulmonary bypass and for 12 h post-surgery, or to receive standard care without NO. The primary outcome is AKI incidence within 48 h postoperatively, defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Secondary outcomes include AKI severity, urine output, vasoactive-inotropic score, neutrophil gelatinase-associated lipocalin levels, sequential organ failure assessment score, ventilator support duration, intensive care unit (ICU) and hospital length of stay, and major adverse kidney events, cumulative mediastinal and pericardial drainage volume.
This trial will evaluate whether perioperative NO administration can reduce early AKI and improve renal and clinical outcomes in high-risk ATAAD patients. Findings may provide evidence for a novel nephroprotective strategy in aortic surgery.
ClinicalTrials.gov NCT06622291. Registered on June 26, 2024.
急性肾损伤（AKI）是急性A型主动脉夹层（ATAAD）手术后常见且严重的并发症。一氧化氮（NO）可能通过肾脏保护机制降低AKI的发生率，但ATAAD人群中的证据仍然有限。本试验旨在评估围手术期给予NO是否能降低该人群术后AKI的发生率。
这项单中心、随机、平行组优效性试验将纳入106例接受ATAAD急诊手术的成年患者。参与者将按1:1的比例随机分配，要么在体外循环期间及术后12小时接受百万分之60的NO，要么接受不含NO的标准护理。主要结局是术后48小时内的AKI发生率，根据改善全球肾脏病预后组织（KDIGO）标准定义。次要结局包括AKI严重程度、尿量、血管活性-正性肌力评分、中性粒细胞明胶酶相关脂质运载蛋白水平、序贯器官衰竭评估评分、呼吸机支持持续时间、重症监护病房（ICU）和住院时间，以及主要不良肾脏事件、纵隔和心包累计引流量。
本试验将评估围手术期给予NO是否能降低高危ATAAD患者的早期AKI并改善肾脏及临床结局。研究结果可能为主动脉手术中一种新的肾脏保护策略提供证据。
ClinicalTrials.gov NCT06622291。于2024年6月26日注册。
