Division of Cardiac Surgery, Dalhousie University, Halifax, Nova Scotia, Canada
Department of Clinical Perfusion, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.
BMJ Open. 2024 Aug 28;14(8):e080597. doi: 10.1136/bmjopen-2023-080597.
Surgical repair is the standard of care for most infants and children with congenital heart disease. Cardiopulmonary bypass (CPB) is required to facilitate these operations but elicits a systemic inflammatory response, leading to postoperative organ dysfunction, morbidity and prolonged recovery after the surgery. Subzero-balance ultrafiltration (SBUF) has been shown to extract proinflammatory cytokines continuously throughout the CPB exposure. We hypothesize that a high-exchange SBUF (H-SBUF) will have a clinically relevant anti-inflammatory effect compared with a low-exchange SBUF (L-SBUF).
The ULTrafiltration to enhance Recovery After paediatric cardiac surgery (ULTRA) trial is a randomised, double-blind, parallel-group randomised trial conducted in a single paediatric cardiac surgery centre. Ninety-six patients less than 15 kg undergoing cardiac surgery with CPB will be randomly assigned to H-SBUF during CPB or L-SBUF during CPB in a 1:1 ratio with stratification by The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score 1 and STAT score 2-5. The primary outcome is peak postoperative vasoactive-ventilation-renal score. Time series and peak values of vasoactive-ventilation renal score, vasoactive-inotrope score, ventilation index and oxygenation index will be collected. Secondary clinical outcomes include acute kidney injury, ventilator-free days, inotrope-free days, low cardiac output syndrome, mechanical circulatory support, intensive care unit length of stay and operative mortality. Secondary biomarker data include cytokine, chemokine and complement factor concentrations at baseline before CPB, at the end of CPB exposure and 24 hours following CPB. Analyses will be conducted on an intention-to-treat principle.
The study has ethics approval (#1024932 dated August 31, 2021) and enrolment commenced in September 2021. The primary manuscript and any subsequent analyses will be submitted for peer-reviewed publication.
NCT04920643.
手术修复是大多数患有先天性心脏病的婴儿和儿童的标准治疗方法。体外循环 (CPB) 是进行这些手术所必需的，但会引起全身炎症反应，导致术后器官功能障碍、发病率增加和手术后恢复时间延长。亚零平衡超滤 (SBUF) 已被证明可以在整个 CPB 暴露过程中持续提取促炎细胞因子。我们假设高交换 SBUF (H-SBUF) 将与低交换 SBUF (L-SBUF) 相比具有临床相关的抗炎作用。
小儿心脏外科学 ULTrafiltration 以增强术后恢复试验 (ULTRA) 是一项在单一小儿心脏手术中心进行的随机、双盲、平行组随机试验。96 名体重小于 15 公斤的接受 CPB 心脏手术的患者将按照 1:1 的比例随机分配到 CPB 期间的 H-SBUF 或 L-SBUF 中，分层为胸外科医生-欧洲心胸外科学会 (STAT) 评分 1 和 STAT 评分 2-5。主要结局是术后峰值血管活性-通气-肾功能评分。将收集血管活性-通气-肾功能评分、血管活性-正性肌力评分、通气指数和氧合指数的时间序列和峰值值。次要临床结局包括急性肾损伤、无呼吸机天数、无正性肌力药物天数、低心输出综合征、机械循环支持、重症监护病房住院时间和手术死亡率。次要生物标志物数据包括 CPB 前基线、CPB 暴露结束时和 CPB 后 24 小时的细胞因子、趋化因子和补体因子浓度。分析将基于意向治疗原则进行。
该研究已获得伦理批准 (#1024932 日期为 2021 年 8 月 31 日)，并于 2021 年 9 月开始入组。主要手稿和任何后续分析将提交同行评审发表。
NCT04920643。
