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中西医结合治疗重症脓毒症胃肠功能障碍临床研究
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注册号:

Registration number:

ChiCTR-IOR-15007625 

最近更新日期:

Date of Last Refreshed on:

2015-12-23 

注册时间:

Date of Registration:

2015-11-18 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

中西医结合治疗重症脓毒症胃肠功能障碍临床研究 

Public title:

Integrated Chinese and Western Medicine for treatment of gastrointestinal dysfunction in patients with severe sepsis: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中西医结合治疗重症脓毒症胃肠功能障碍临床研究 

Scientific title:

Integrated Chinese and Western Medicine for treatment of gastrointestinal dysfunction in patients with severe sepsis: 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:

江荣林 

研究负责人:

江荣林 

Applicant:

Jiang Ronglin 

Study leader:

Jiang Ronglin 

申请注册联系人电话:

Applicant telephone:

+86 13958095268 

研究负责人电话:

Study leader's telephone:

+86 13958095268 

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:

jiangronglin15@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

jiangronglin15@sina.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:

浙江省杭州市邮电路54号 

研究负责人通讯地址:

浙江省杭州市邮电路54号 

Applicant address:

54 Youdian Road, Hangzhou, Zhejiang, China 

Study leader's address:

54 Youdian Road, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310006 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

浙江中医药大学附属第一医院(浙江省中医院) 

Applicant's institution:

Zhejiang Provincial Hospital of TCM 

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:

2014-K-183-01 

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:

浙江中医药大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethic Committee of Zhejiang Provincial Hospital of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-02-25 

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:

浙江中医药大学附属第一医院(浙江省中医院) 

Primary sponsor:

Zhejiang Provincial Hospital of TCM 

研究实施负责(组长)单位地址:

浙江省杭州市邮电路54号 

Primary sponsor's address:

54 Youdian Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江中医药大学附属第一医院(浙江省中医院)

具体地址:

浙江省杭州市邮电路54号

Institution
hospital:

Zhejiang Provincial Hospital of TCM

Address:

54 Youdian Road, Hangzhou, Zhejiang, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-funded 

研究疾病:

重症脓毒症胃肠功能障碍 

Target disease:

gastrointestinal dysfunction in severe sepsis 

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:

其它 

Study phase:

N/A 

研究目的:

①了解重度脓毒症时胃肠功能障碍的中医证型特点及各证型分布和变化规律。②对于重度脓毒症且已发生胃肠功能障碍的患者,评价在西医常规治疗基础上应用中医药的集束化治疗措施,是否可以降低减少多脏器功能不全的发生,降低死亡率,并缩短ICU住院时间。 

Objectives of Study:

1. To investigate characteristics and distribution of TCM Syndromes of gastrointestinal dysfunction in severe sepsis; 2. Evaluate the efficacy integrated Chinese and Western Medicine for treatment of gastrointestinal dysfunction in severe sepsis patients. 

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:

A、符合重度脓毒症诊断标准且有胃肠功能障碍者; B、胃肠功能损伤评分≥2分者(胃肠功能损伤评分参考95’庐山会议标准 ); C、年龄≥18 岁。 

Inclusion criteria

1. Patients diagnosed with severe sepsis, and with gastrointestinal dysfunction; 2. Gastrointestinal dysfunction score >=2; 3. Age >= 18 yr. 

排除标准:

A、 年龄< 18 岁; B、 孕妇或哺乳期的妇女; C、 恶性肿瘤晚期; D、 人类免疫缺陷病毒(HIV) 感染; E、 治疗未超过7天死亡或出院者; F、 格拉斯哥昏迷评分(GCS) ≤6 分; G、 患者家属拒绝参加本研究者。 

Exclusion criteria:

1. Age < 18 yr; 2. Pregnant or lactating women; 3. With advanced malignant tumor; 4. Infected by HIV; 5. Death or discharge within 7 days from the beginning of treatment; 6. GCS <= 6; 7. Family members refuse to participate in this trial. 

研究实施时间:

Study execute time:

From2012-09-01To 2016-12-31 

征募观察对象时间:

Recruiting time:

From2012-09-01To 2016-12-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

150

Group:

Treatment group

Sample size:

干预措施:

西医常规+集束化中医药措施

干预措施代码:

Intervention:

Routine western medicine+TCM

Intervention code:

组别:

对照组

样本量:

150

Group:

Control group

Sample size:

干预措施:

西医常规

干预措施代码:

Intervention:

Routine western medicine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江中医药大学附属第一医院(浙江省中医院) 

单位级别:

三甲 

Institution
hospital:

Zhejiang Provincial Hospital of TCM  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

中医证型

指标类型:

次要指标 

Outcome:

TCM Syndrome

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

28天转归情况

指标类型:

主要指标 

Outcome:

Outcome at 28d

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

症状积分

指标类型:

主要指标 

Outcome:

Syndrome score

Type:

Primary 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:

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 18 years
最大 Max age 80 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

简单随机化。主要研究者采用随机数表法进行随机。

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

Simple randomization.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

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

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:

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-11-18
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