Wieruszewski Patrick M, Radosevich Misty A, Nei Scott D, Kashani Kianoush B, Normand Sarah E, Schaff Hartzell V, Wittwer Erica D
Department of Pharmacy, Mayo Clinic, 200 First Street SW, RO_MB_GR_722PH, Rochester, MN, 55905, USA.
Department of Anesthesiology, Mayo Clinic, 200 First Street SW, RO_MB_GR_722PH, Rochester, MN, USA.
J Cardiothorac Surg. 2025 May 22;20(1):234. doi: 10.1186/s13019-025-03486-8.
Ascorbic acid is an essential cofactor of catecholamine synthesis that increases capillary bed density and improves microcirculation perfusion. We hypothesized early ascorbic acid administration in cardiothoracic surgery would preserve the microcirculatory integrity and minimize postoperative vasoplegia.
This was a single-arm pilot feasibility study of adults undergoing septal myectomy combined with valve intervention or alone using cardiopulmonary bypass. Intravenous ascorbic acid 1,500 mg was administered before and immediately following cardiopulmonary bypass and every 6 h after for 12 doses. Three historical controls were identified and matched to each trial participant on age, gender, body mass index, preoperative ejection fraction, surgery performed, and time on cardiopulmonary bypass. The feasibility endpoint was a composite of successful and timely 1) ascorbic acid administration, 2) laboratory assessment, and 3) microcirculation measurements across the perioperative phases of care. Clinical endpoints included vasoplegia incidence, acute kidney injury, and lengths of stay compared to controls.
Fifteen patients were enrolled and compared to 45 historically matched controls. Participants' median baseline plasma ascorbic acid concentration was 0.5 (0.3, 0.9) mg/dL. Four (27%) patients had suboptimal concentrations. Eleven participants (75%) did not meet the feasibility composite endpoint due to the inability of microcirculation measurement. Incidence of vasoplegia and acute kidney injury, vasopressor duration, and lengths of stay were similar between participants and historical controls. No drug-related adverse events were noted.
Timely microcirculation measurements were challenging in the complex cardiothoracic surgery environment. Compared to historical controls, no meaningful differences in clinical endpoints were noted with ascorbic acid treatment. The utility of ascorbic acid on post-cardiopulmonary bypass vasoplegia remains unclear.
ClinicalTrials.gov (NCT03744702, registered on November 14, 2018).
抗坏血酸是儿茶酚胺合成的必需辅助因子，可增加毛细血管床密度并改善微循环灌注。我们假设在心胸外科手术中早期给予抗坏血酸可维持微循环完整性并使术后血管麻痹降至最低。
这是一项单臂试点可行性研究，研究对象为接受室间隔心肌切除术联合瓣膜干预或仅接受体外循环手术的成年人。在体外循环前和体外循环后立即静脉注射1500毫克抗坏血酸，之后每6小时注射一次，共注射12剂。确定了三名历史对照者，并在年龄、性别、体重指数、术前射血分数、所进行的手术以及体外循环时间等方面与每位试验参与者进行匹配。可行性终点是在围手术期护理的各个阶段成功且及时地进行1）抗坏血酸给药、2）实验室评估和3）微循环测量的综合指标。临床终点包括与对照组相比的血管麻痹发生率、急性肾损伤和住院时间。
共纳入15名患者，并与45名历史匹配对照者进行比较。参与者的基线血浆抗坏血酸浓度中位数为0.5（0.3，0.9）毫克/分升。4名（27%）患者的浓度未达最佳水平。11名参与者（75%）未达到可行性综合终点，原因是无法进行微循环测量。参与者与历史对照者之间的血管麻痹和急性肾损伤发生率、血管升压药使用时长以及住院时间相似。未观察到与药物相关的不良事件。
在复杂的心胸外科手术环境中，及时进行微循环测量具有挑战性。与历史对照者相比，抗坏血酸治疗在临床终点方面未观察到有意义的差异。抗坏血酸对体外循环后血管麻痹的作用仍不明确。
ClinicalTrials.gov（NCT03744702，于2018年11月14日注册）。
