急性B型主动脉夹层患者强化血压控制（RAID）：一项随机对照试验的研究方案
Intensive blood pressure control in patients with acute type B aortic dissection (RAID): study protocol for randomized controlled trial.
作者信息
Zhou Jian-Cang, Zhang Nan, Zhang Zhong-Heng, Wang Ting-Ting, Zhu Yue-Feng, Kang Hui, Zhang Wei-Min, Li Dong-Lin, Li Wei-Dong, Liu Zhen-Jie, Qian Xi-Min, Zhang Ming-You, Wang Jue, Zhou Mi, Yang Zhi-Tao, Yu Yun-Xian, Li Hang-Yang, Zhang Jian, Wang Yong-Gang, Gao Jian-Ping, Ling Lin, Pan Kong-Han
机构信息
Department of Critical Care Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310016, China.
Department of Emergency, The First Hospital of Jilin University, Changchun 130021, China.
出版信息
J Thorac Dis. 2017 May;9(5):1369-1374. doi: 10.21037/jtd.2017.03.180.
BACKGROUND
Blood pressure control is an essential therapy for patients with acute type B aortic dissection (ABAD) and should be maintained throughout the entire treatment. Thus, vast majority current guidelines recommend control the blood pressure to lower than 140/90 mmHg. Theoretically, a much lower target may further decrease the risk of propagation of dissection. However, some argued that too lower blood pressure would compromise the organ perfusion. Thus, there is no unanimous optimal target for blood pressure in patients with ABAD so far. The present study aimed to investigate the optimal blood pressure target for patients with ABAD, in the hope that the result would optimize the treatment of aortic dissection (AD).
METHODS
The study is a multi-center randomized controlled clinical trial. Study population will include patients with new diagnosed ABAD and hypertension. Blocked randomization was performed where intensive blood pressure control (<120 mmHg) with conventional blood pressure control (<140 mmHg) were allocated at random in a ratio of 1:1 in blocks of sizes 4, 6, 8, and 10 to 360 subjects. Interim analysis will be performed. The primary outcome is a composite in-hospital adverse outcome, including death, permanent paraplegia or semi- paralysis during the hospitalization, and renal failure requiring hemodialysis at discharge. While the secondary outcomes include the aortic size, lower extremity or visceral ischemia, retrograde propagation into aortic arch or ascending aorta, mortality in 6 months and 1 year, intensive care unit (ICU) length of stay, total length of hospital stay, creatinine level, and surgical or endovascular intervention.
ETHICS AND DISSEMINATION
The study was approved by the institutional review board of Sir Run Run Shaw Hospital (approval number: 20160920-9). Informed consent will be obtained from participants or their next-of-kin. The results will be published in a peer-reviewed journal and shared with the worldwide medical community.
TRIAL REGISTRATION
NCT03001739 (https://register.clinicaltrials.gov/).
背景
血压控制是急性B型主动脉夹层（ABAD）患者的重要治疗手段，且应在整个治疗过程中维持。因此，目前绝大多数指南建议将血压控制在低于140/90 mmHg。理论上，更低的目标血压可能会进一步降低夹层扩展风险。然而，一些人认为血压过低会损害器官灌注。因此，目前对于ABAD患者的血压尚无一致的最佳目标。本研究旨在探讨ABAD患者的最佳血压目标值，并期望该结果能优化主动脉夹层（AD）的治疗。
方法
本研究为多中心随机对照临床试验。研究对象将包括新诊断的ABAD和高血压患者。采用区组随机化方法将强化血压控制组（<120 mmHg）和传统血压控制组（<140 mmHg）按1∶1随机分配到大小为4、6、8和10的区组中，共360例受试者。将进行中期分析。主要结局为住院期间复合不良结局，包括死亡、住院期间永久性截瘫或偏瘫，以及出院时需要血液透析的肾衰竭。次要结局包括主动脉大小、下肢或内脏缺血、夹层逆行扩展至主动脉弓或升主动脉、6个月和1年时的死亡率、重症监护病房（ICU）住院时间、总住院时间、肌酐水平，以及手术或血管腔内干预。
伦理与传播
本研究已获得浙江大学医学院附属邵逸夫医院伦理委员会批准（批准号：20160920 - 9）。将获得参与者或其近亲的知情同意。研究结果将发表于同行评审期刊，并与全球医学界共享。
试验注册
NCT03001739（https://register.clinicaltrials.gov/）
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