Article Abstract

Intensive blood pressure control in patients with acute type B aortic dissection (RAID): study protocol for randomized controlled trial

Authors: Jian-Cang Zhou, Nan Zhang, Zhong-Heng Zhang, Ting-Ting Wang, Yue-Feng Zhu, Hui Kang, Wei-Min Zhang, Dong-Lin Li, Wei-Dong Li, Zhen-Jie Liu, Xi-Min Qian, Ming-You Zhang, Jue Wang, Mi Zhou, Zhi-Tao Yang, Yun-Xian Yu, Hang-Yang Li, Jian Zhang, Yong-Gang Wang, Jian-Ping Gao, Lin Ling, Kong-Han Pan, for the Pressure in Acute Type B Aortic Dissection (RAID) study group

Abstract

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/).