Department of Cardiac Surgery, Nanjing Drum Tower Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Graduate School of Peking Union Medical College, Beijing, China.
Department of Cardiac Surgery, Nanjing Drum Tower Hospital, Clinical College of Nanjing University of Chinese Medicine, Nanjing, China.
BMJ Open. 2024 Sep 12;14(9):e084368. doi: 10.1136/bmjopen-2024-084368.
The systemic inflammatory response syndrome during the perioperative period of cardiac surgery can lead to serious postoperative complications and significantly increase the hospital mortality rate. Colchicine, a widely used traditional anti-inflammatory drug, has good clinical value in cardiovascular anti-inflammatory therapy. Our preliminary single-centre study had confirmed the protective value of colchicine in patients undergoing cardiac surgery with cardiopulmonary bypass. For this multicentre investigation, we aim to further validate the anti-inflammatory and organ-protective effects of low-dose colchicine during the perioperative period in a low-risk population.
This study is a multicentre, randomised, double-blind, placebo-controlled clinical trial. A total of 768 patients undergoing elective cardiac surgery will be enrolled from eight heart centres in China. The participants will be randomly assigned to two groups: the colchicine group will receive low-dose colchicine (0.5 mg once-a-day dosing regimen (QD) orally for 3 days before the surgery and 0.5 mg dosing frequency of every other day (QOD) continuously for 10 days after the surgery), whereas the placebo group will be given starch tablets for the same time and dosage. Primary endpoints are the occurrence of postoperative inflammatory diseases, including postoperative atrial fibrillation, acute respiratory distress syndrome, preoperative myocardial injury and post-pericardiotomy syndrome. Secondary endpoints included laboratory tests on postoperative days 1, 3, 5, 7 and 10, intensive care unit data, APACHE II score, Murray lung injury score, medication-related gastrointestinal reactions, 30-day and 90-day all-cause mortality, surgical data, chest radiograph on postoperative days 1, 2 and 3, and chest CT within 14 days after surgery.
This research has received approval from the Medical Ethics Committee of Affiliated Nanjing Drum Tower Hospital, Nanjing University Medical College (approval number 2023-366-01). The study findings will be made available by publishing them in an open access journal.
ClinicalTrials.gov (NCT06118034).
心脏手术围手术期的全身炎症反应综合征可导致严重的术后并发症，并显著增加医院死亡率。秋水仙碱是一种广泛应用的传统抗炎药物，在心血管抗炎治疗中具有良好的临床价值。我们的初步单中心研究已经证实了秋水仙碱在体外循环心脏手术后患者中的保护作用。对于这项多中心研究，我们旨在进一步验证在低风险人群中，围手术期低剂量秋水仙碱的抗炎和器官保护作用。
这是一项多中心、随机、双盲、安慰剂对照的临床试验。将从中国 8 个心脏中心招募 768 名择期心脏手术患者。参与者将被随机分为两组：秋水仙碱组将接受低剂量秋水仙碱（术前 3 天每天口服 0.5mg，1 天 1 次；术后 10 天连续每天口服 0.5mg，每两天 1 次），而安慰剂组将给予淀粉片相同的时间和剂量。主要终点是术后炎症性疾病的发生，包括术后心房颤动、急性呼吸窘迫综合征、术前心肌损伤和心包切开后综合征。次要终点包括术后第 1、3、5、7 和 10 天的实验室检查、重症监护数据、APACHE II 评分、Murray 肺损伤评分、与药物相关的胃肠道反应、30 天和 90 天全因死亡率、手术数据、术后第 1、2 和 3 天的胸部 X 线片以及术后 14 天内的胸部 CT。
这项研究已获得南京鼓楼医院附属南京医科大学医学伦理委员会的批准（批准号：2023-366-01）。研究结果将通过在开放获取期刊上发表公布。
ClinicalTrials.gov（NCT06118034）。
