Jian-Cang Zhou1, Nan Zhang2, Zhong-Heng Zhang3,4, Ting-Ting Wang1, Yue-Feng Zhu5, Hui Kang6, Wei-Min Zhang7, Dong-Lin Li8, Wei-Dong Li9, Zhen-Jie Liu10, Xi-Min Qian7, Ming-You Zhang2, Jue Wang11, Mi Zhou12, Zhi-Tao Yang13, Yun-Xian Yu14, Hang-Yang Li1, Jian Zhang1, Yong-Gang Wang1, Jian-Ping Gao1, Lin Ling1, Kong-Han Pan1. 1. Department of Critical Care Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310016, China. 2. Department of Emergency, The First Hospital of Jilin University, Changchun 130021, China. 3. Department of Critical Care Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University, Jinhua 321000, China. 4. Department of Emergency Medicine, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310016, China. 5. Department of Vascular Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310016, China. 6. Department of Critical Care Medicine, West China Hospital, Sichuan University School of Medicine, Chengdu 610041, China. 7. Department of Cardiac Surgery, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou 310016, China. 8. Department of Vascular Surgery, 1 affiliated Hospital Zhejiang University School of Medicine, Hangzhou 310003, China. 9. Department of Cardiac Surgery, 1 affiliated Hospital Zhejiang University School of Medicine, Hangzhou 310003, China. 10. Department of Vascular Surgery, 2 affiliated Hospital Zhejiang University School of Medicine, Hangzhou 310009, China. 11. Department of Cardiac Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China. 12. Department of Cardiac Surgery, Rui Jin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China. 13. Department of Emergency Medicine, Rui Jin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China. 14. Department of Biomedical Informatics, Zhejiang University School of Medicine, Hangzhou 310016, China.
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/).
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/).
Entities:
Keywords:
Aortic dissection (AD); Stanford B type; intensive care unit (ICU); mortality; randomized controlled trial
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