Today is 2021-03-05

Blood Pressure Management on Cardiovascular Adverse Events After Major Abdominal Surgery (BP-CARES): a Randomized Controlled Trial
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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:

 

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:

 

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):

 

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 

Applicant's institution:

Southern Hospital of Southern Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

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 

Name of the ethic committee:

Medical Ethic Committee of Southern Hospital of Southern Medical University 

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 

Contact Name of the ethic committee:

Xun Zhang 

伦理委员会联系地址:

中国广州市广州大道北1838号 

Contact Address of the ethic committee:

1838 Guangzhou Avenue North, Guangzhou, Guangdong, China 

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 

Primary sponsor:

Southern Hospital of Southern Medical University 

研究实施负责(组长)单位地址:

中国广州市广州大道北1838号 

Primary sponsor's address:

1838 Guangzhou Avenue North, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医科大学南方医院

具体地址:

广州大道北1838号

Institution
hospital:

Southern Hospital of Southern Medical University

Address:

1838 Guangzhou Avenue North

经费或物资来源:

中国博士后科学基金会 

Source(s) of funding:

China Postdoctoral Science Foundation 

研究疾病:

非心脏手术后心血管事件 

Target disease:

Cardiovascular events after non-cardiac surgery 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

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。  

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.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

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。 

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. 

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。 

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:

From2020-06-08To 2025-06-08 

征募观察对象时间:

Recruiting time:

From2020-06-08To 2022-06-08 

干预措施:

Interventions:

组别:

强化术中血压管理组

样本量:

750

Group:

Intensive intraoperative blood pressure management group

Sample size:

干预措施:

控制术中平均动脉压不低于80mmHg

干预措施代码:

Intervention:

Target intraoperative MAP at or above 80 mmHg

Intervention code:

组别:

常规术中血压管理组

样本量:

750

Group:

Conventional intraoperative blood pressure management group

Sample size:

干预措施:

控制术中平均动脉压不低于65mmHg

干预措施代码:

Intervention:

Target intraoperative MAP at or above 65 mmHg

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医科大学南方医院 

单位级别:

三级甲等 

Institution
hospital:

Southern Medical University Nanfang Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

陆军军医大学新桥医院 

单位级别:

三级甲等 

Institution
hospital:

Army Medical University Xinqiao Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

He'nan 

City:

Zhengzhou 

单位(医院):

河南省人民医院 

单位级别:

三级甲等 

Institution
hospital:

He'nan Provincial People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

主要心血管不良事件(包括术后心肌损伤/梗死、新发临床重要心律失常、心力衰竭、脑卒中、心跳骤停、全因死亡)

指标类型:

主要指标 

Outcome:

Major adverse cardiac events (a composite of myocardial injury/infarction, new-onset clinically important arrhythmia, heart failure, stroke, cardiac arrest, and all-cause death after surgery)

Type:

Primary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30-day after surgery

Measure method:

指标中文名:

主要非心血管并发症

指标类型:

次要指标 

Outcome:

Major non-cardiovascular complications

Type:

Secondary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30-day after surgery

Measure method:

指标中文名:

30天非住院生存时间

指标类型:

次要指标 

Outcome:

Days alive and out of hospital

Type:

Secondary indicator 

测量时间点:

术后30天

测量方法:

Measure time point of outcome:

30-day after surgery

Measure method:

指标中文名:

无失能生存率

指标类型:

次要指标 

Outcome:

Disability-free survival

Type:

Secondary indicator 

测量时间点:

术后6个月

测量方法:

Measure time point of outcome:

6-month after surgery

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 45 years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

使用在线随机化系统app.studyrandomizer.com进行分层区组随机。

Randomization Procedure (please state who generates the random number sequence and by what method):

Use online randomization system (app.studyrandomizer.com) Conduct stratified block random.

盲法:

对临床结局评估者采用盲法。

Blinding:

Blind method for outcome evaluators.

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

通过合理申请后向申请人公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Data will be available upon reasonable request

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表与电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case record form and electronic data capture system

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-06-08
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