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Multicenter, open-label, randomized controlled trial on Shenfu injection for shock
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注册号:

Registration number:

ChiCTR-TRC-11001369 

最近更新日期:

Date of Last Refreshed on:

2015-07-12 

注册时间:

Date of Registration:

2011-05-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

参附注射液治疗休克的随机对照开放多中心临床研究 

Public title:

Multicenter, open-label, randomized controlled trial on Shenfu injection for shock 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

参附注射液治疗休克的随机对照开放多中心临床研究 

Scientific title:

Multicenter, open-label, randomized controlled trial on Shenfu injection for shock 

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:

李毅 

研究负责人:

于学忠 

Applicant:

Yi LI 

Study leader:

Xuezhong YU 

申请注册联系人电话:

Applicant telephone:

+86 10 65295301 

研究负责人电话:

Study leader's telephone:

+86 10 65295301 

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:

billliyi@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

yxz@medmail.com.cn 

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:

北京市东城区帅府园1号北京协和医院急诊科 

研究负责人通讯地址:

北京市东城区帅府园1号北京协和医院急诊科 

Applicant address:

Emergency Department, Peking Union Medical College Hospital, 1 Shuaifuyuan, Dongcheng District, Beijing 

Study leader's address:

Emergency Department, Peking Union Medical College Hospital, 1 Shuaifuyuan, Dongcheng District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100005 

研究负责人邮政编码:

Study leader's postcode:

100005 

申请人所在单位:

北京协和医院 

Applicant's institution:

Peking Union Medical College Hospital 

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:

s-377 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

中国医学科学院北京协和医院伦理审查委员会 

Name of the ethic committee:

Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-05-30 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

北京协和医院 

Primary sponsor:

Peking Union Medical College Hospital 

研究实施负责(组长)单位地址:

北京市东城区帅府园1号 

Primary sponsor's address:

1 Shuaifuyuan, Dongcheng District, Beijing 

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):

Country:

China

Province:

Guangdong

City:

单位(医院):

华润三九医药股份有限公司

具体地址:

深圳市罗湖区北环大道1028号

Institution
hospital:

China Resource Sanjiu Medical & Pharmaceutical Co., Ltd

Address:

1028 Beihuan Blvd, Shenzhen

经费或物资来源:

华润三九医药股份有限公司 

Source(s) of funding:

China Resource Sanjiu Medical & Pharmaceutical Co., Ltd. 

研究疾病:

休克 

Target disease:

shock 

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:

上市后药物 

Study phase:

研究目的:

通过随机安慰剂对照,观察参附注射液对不同类型休克的有效性、作用特点和安全性,为其合理用药提供科学依据。 

Objectives of Study:

To evaluate the efficacy of Shenju injection for shock and to offer scientific envidence of clinical use of Shenfu injection towards shock by randomized controlled trial 

药物成份或治疗方案详述:

附片 含有水溶性生物碱等有效成分 ;红参 含有人参皂甙等有效成分 

Description for medicine or protocol of treatment in detail:

Monkshood Water-soluble alkaloids ;Red Ginseng Ginsenoside 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1、符合各类型休克诊断标准; 2、年龄:18-70岁。 

Inclusion criteria

1. Consistent with the diagnosis of shock; 2. age between 18 and 70. 

排除标准:

1、预后恶劣,很可能在24h内死亡的患者,如特重型颅脑损伤、心肺复苏术后、恶性肿瘤晚期、严重慢性心、肝、肺、肾、凝血等器官系统疾病患者等; 2、“低血容量休克”若6h内需手术者; 3、放弃抢救,未能坚持系统治疗者(只能是因病人原因); 4、过敏体质者,有药物、食物过敏史或已知对本药组成成分过敏者; 5、妊娠或哺乳期妇女; 6、外籍人士; 7、近3月内参加过其它临床研究者; 8、研究者判断的其它不适合入组的患者。 

Exclusion criteria:

1. Poor prognosis, life expectancy < 24h; 2. With hypovolemic shock and require emergent surgery within 6h; 3. Give up medical resuscitation, failure to adhere to the systemic treatment (only for reasons from patients); 4. Allergic to drugs, food or medicine composition used in the trial; 5. Pregnant or lactating women; 6. Foreigners; 7. Participate in other clinical trials in the past 3 months ; 8. With other conditions that the researchers consider not fit this trial. 

研究实施时间:

Study execute time:

From2011-05-01To 2012-12-31 

征募观察对象时间:

Recruiting time:

From2011-06-01To  

干预措施:

Interventions:

组别:

对照组

样本量:

200

Group:

Control group

Sample size:

干预措施:

生理盐水静脉泵入,每天300ml,一共6天

干预措施代码:

Intervention:

Saline 300ml intravenous injection for 6 days

Intervention code:

组别:

治疗组

样本量:

200

Group:

Treatment group

Sample size:

干预措施:

参附注射液静脉泵入,每天100ml,加200ml生理盐水稀释,一共6天

干预措施代码:

Intervention:

Shenfu injection intravenous injection for 6 days, 100ml Shenfu injection diluted with 200ml saline per day

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京协和医院 

单位级别:

三级甲等 

Institution
hospital:

Peking Union Medical College Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

东南大学附属中大医院 

单位级别:

三级甲等 

Institution
hospital:

Zhongda Hospital of Southeastern University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

福建 

市(区县):

 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

福建医科大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital of Fujian Medical College  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三级甲等 

Institution
hospital:

Ruijin Hospital of Shanghai Jiaotong University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属新华医院 

单位级别:

三级甲等 

Institution
hospital:

Xinhua Hospital of Shanghai Jiaotong University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉大学人民医院 

单位级别:

三级甲等 

Institution
hospital:

People's Hospital of Wuhan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

卫生部北京医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属邵逸夫医院 

单位级别:

三级甲等 

Institution
hospital:

Shaoyifu Hospital of Zhejiang University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

乳酸清除率

指标类型:

主要指标 

Outcome:

Lactate clearance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气分析

指标类型:

次要指标 

Outcome:

Blood gas analysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎性因子

指标类型:

次要指标 

Outcome:

Inflammatory factor

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血流动力学

指标类型:

次要指标 

Outcome:

Picc

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

休克指数,GCS评分,APACHE II评分

指标类型:

附加指标 

Outcome:

shock index, Glasgow score, APACHE II score

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

计算机软件

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

computer generation

盲法:

病人 是

Blinding:

patients: yes

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):

上海中医药大学药物临床研究中心

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

Drug Research Center of Shanghai Chinese Medicine College

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:

上海中医药大学药物临床研究中心

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

Drug Research Center of Shanghai Chinese Medicine College

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2011-05-26
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