注册号: Registration number: |
ChiCTR2000033672 |
最近更新日期: Date of Last Refreshed on: |
2020-06-08 |
注册时间: Date of Registration: |
2020-06-08 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
血压管理策略对大型腹部手术后心血管事件的影响: 一项随机对照试验 |
Public title: |
Blood Pressure Management on Cardiovascular Adverse Events After Major Abdominal Surgery (BP-CARES): a Randomized Controlled Trial |
注册题目简写: |
BP-CARES |
English Acronym: |
BP-CARES |
研究课题的正式科学名称: |
血压管理策略对大型腹部手术后心血管事件的影响: 一项随机对照试验 |
Scientific title: |
Blood Pressure Management on Cardiovascular Adverse Events After Major Abdominal Surgery (BP-CARES): a Randomized Controlled Trial |
研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
申请注册联系人: |
赵秉诚 |
研究负责人: |
刘克玄 |
Applicant: |
Bingcheng Zhao |
Study leader: |
Kexuan Liu |
申请注册联系人电话: Applicant telephone: |
+86 13763313653 |
研究负责人电话: Study leader's telephone: |
+86 13710684096 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
zhaobch@mail2.sysu.edu.cn |
研究负责人电子邮件: Study leader's E-mail: |
liukexuan705@163.com |
申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
中国广州市广州大道北1838号 |
研究负责人通讯地址: |
中国广州市广州大道北1838号 |
Applicant address: |
1838 Guangzhou Avenue North, Guangzhou, Guangdong, China |
Study leader's address: |
1838 Guangzhou Avenue North, Guangzhou, Guangdong, China |
申请注册联系人邮政编码: Applicant postcode: |
510515 |
研究负责人邮政编码: Study leader's postcode: |
510515 |
申请人所在单位: |
南方医科大学南方医院 |
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Applicant's institution: |
Southern Hospital of Southern Medical University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
NFEC-2019-261 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
批准本研究的伦理委员会名称: |
南方医科大学南方医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethic Committee of Southern Hospital of Southern Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2019-12-28 | ||
伦理委员会联系人: |
张训 |
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Contact Name of the ethic committee: |
Xun Zhang |
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伦理委员会联系地址: |
中国广州市广州大道北1838号 |
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Contact Address of the ethic committee: |
1838 Guangzhou Avenue North, Guangzhou, Guangdong, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 20-62787238 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
nfyyec@163.com |
研究实施负责(组长)单位: |
南方医科大学南方医院 |
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Primary sponsor: |
Southern Hospital of Southern Medical University |
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研究实施负责(组长)单位地址: |
中国广州市广州大道北1838号 |
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Primary sponsor's address: |
1838 Guangzhou Avenue North, Guangzhou, Guangdong, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
中国博士后科学基金会 |
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Source(s) of funding: |
China Postdoctoral Science Foundation |
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研究疾病: |
非心脏手术后心血管事件 |
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Target disease: |
Cardiovascular events after non-cardiac surgery |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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研究目的: |
术中低血压与非心脏手术术后心血管事件相关,但避免术中低血压能否降低术后心血管事件发生率仍不明确。本研究的目的是探索强化术中血压管理策略(维持术中平均动脉压不低于80mmHg)相比于传统的术中血压管理方案(维持术中平均动脉压不低于65mmHg)能否降低大型腹部手术患者术后心血管事件的发生。 |
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Objectives of Study: |
Intraoperative hypotension has been associated with cardiovascular events after non-cardiac surgery. However, whether avoiding intraoperative hypotension can reduce the incidence of postoperative cardiovascular events remains unclear. The objective of this study is to assess the effects of an intensive intraoperative blood pressure management strategy (to maintain intraoperative MAP >= 80mmHg) with that of conventional practice (to maintain intraoperative MAP >= 65mmHg) on the incidence of cardiovascular events after major abdominal surgery. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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纳入标准: |
(1)年龄大于等于45周岁; (2)计划择期在全身麻醉下进行大型腹部手术(预计手术时间大于2小时,术后住院时间大于2天); (3)患者有以下四种疾病中的一种或以上: a. 冠心病; b. 脑卒中; c. 周围动脉血管疾病; d. 充血性心力衰竭; e. 术前NT-proBNP大于200pg/mL或BNP大于92 mg/L; f. 术前Troponin水平大于正常范围上限; 或患者存在以下心血管危险因素中的两种及以上: g. 慢性肾脏病(术前Cr大于133μmol/L即1.5 mg/dL); h. 需要药物治疗的糖尿病; i. 吸烟(过去至少2年内持续); j. 年龄65岁及以上; k. 需要药物治疗的高血压; l. 高胆固醇血症。 |
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Inclusion criteria |
1. The age is more than or equal to 45 years old; 2. It is planned to carry out large-scale abdominal operation under general anesthesia (the estimated operation time is more than 2 hours, and the postoperative hospitalization time is more than 2 days); 3. The patient has one or more of the following four diseases: (1) Coronary heart disease; (2) Stroke; (3) Peripheral arterial disease; (4) Congestive heart failure; (5) NT proBNP was more than 200 pg / ml or BNP was more than 92 mg / L before operation; (6) The preoperative troponin level was higher than the upper limit of normal range, or the patient had two or more of the following cardiovascular risk factors: (7) Chronic kidney disease (CR > 133 μ mol / L or 1.5 mg / dl before operation); (8) Diabetes requiring medication; (9) Smoking (continued for at least 2 years); (10) Aged 65 years and above; (11) Hypertension requiring medication; (12) Hypercholesterolemia. |
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排除标准: |
(1)ASA分级≥5级; (2)术前控制不良的严重高血压(收缩压>180mmHg或舒张压>110 mmHg); (3)需要肾脏替代疗法治疗的终末期肾病; (4)急性心脑血管事件(包括近1个月内的心力衰竭、急性冠状动脉综合征、脑卒中); (5)术前诊断为脓毒症; (6)术前需要接受血管活性药物治疗; (7)正在参加另一项干预性临床研究; (8)曾参与本研究; (9)孕妇或哺乳期妇女。 |
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Exclusion criteria: |
1. Patients with ASA grade >= 5; 2. Severe hypertension patients with poor preoperative control (systolic blood pressure > 180mmhg or diastolic blood pressure > 110mmhg); 3. Patients with end-stage renal disease requiring renal replacement therapy; 4. Patients with acute cardiovascular and cerebrovascular events (including heart failure, acute coronary syndrome and stroke in the past 1 month); 5. Patients diagnosed as sepsis before operation; 6. Patients who need to receive vasoactive drugs before operation; 7. Patients who are participating in another intervention clinical study; 8. Patients who have participated in this study; 9. Pregnant or lactating women. |
研究实施时间: Study execute time: |
从From2020-06-08至To 2025-06-08 |
征募观察对象时间: Recruiting time: |
从From2020-06-08至To 2022-06-08 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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