今天是:2019-07-17 星期三

脑外伤及脑出血患者下呼吸道微生态与呼吸机相关性肺炎的关联研究
下载XML文档

注册号:

Registration number:

ChiCTR1900020650 

最近更新日期:

Date of Last Refreshed on:

2019-01-11 

注册时间:

Date of Registration:

2019-01-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

脑外伤及脑出血患者下呼吸道微生态与呼吸机相关性肺炎的关联研究 

Public title:

Association between lower respiratory tract microecology and ventilator-associated pneumonia in patients with brain injury and cerebral hemorrhage 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

脑外伤及脑出血患者下呼吸道微生态与呼吸机相关性肺炎的关联研究 

Scientific title:

Association between lower respiratory tract microecology and ventilator-associated pneumonia in patients with brain injury and cerebral hemorrhage 

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:

梅清 

研究负责人:

潘爱军 

Applicant:

Mei Qing 

Study leader:

Pan Aijun 

申请注册联系人电话:

Applicant telephone:

+86 15715513799 

研究负责人电话:

Study leader's telephone:

+86 13866668786 

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:

89318469@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

aijunpan868@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:

中国安徽省合肥市庐江路17号 

研究负责人通讯地址:

中国安徽省合肥市庐江路17号 

Applicant address:

17 Lujiang Road, Hefei, Anhui, China 

Study leader's address:

17 Lujiang Road, Hefei, Anhui, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

中国科学技术大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of University of Science and Technology of China 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

中国科学技术大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of University of Science and Technology of China 

研究实施负责(组长)单位地址:

中国安徽省合肥市庐江路17号 

Primary sponsor's address:

17 Lujiang Road, Hefei, Anhui, 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):

安徽

市(区县):

合肥

Country:

China

Province:

Anhui

City:

Hefei

单位(医院):

中国科学技术大学附属第一医院

具体地址:

中国安徽省合肥市庐江路17号

Institution
hospital:

The First Affiliated Hospital of University of Science and Technology of China

Address:

17 Lujiang Road, Hefei, Anhui, China

经费或物资来源:

国家临床重点专科建设项目 

Source(s) of funding:

National Key Clinical Speciality Construction Project 

研究疾病:

脑外伤及脑出血 

Target disease:

brain injury and cerebral hemorrhage 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

阐释脑外伤及脑出血患者下呼吸道微生态与VAP的相关性,并明确益生菌在预防VAP发生中的作用。 

Objectives of Study:

To elucidate the correlation between lower respiratory tract microecology and VAP in patients with brain injury and cerebral hemorrhage, and to clarify the role of probiotics in the prevention of VAP. 

药物成份或治疗方案详述:

常乐康(酪酸梭菌二联活菌胶囊,3粒,po,bid) 

Description for medicine or protocol of treatment in detail:

Changle Kang (Clostridium butyricum bivalent viable capsule, 3 capsules, po, bid) 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

纳入标准 1. 脑外伤或脑出血患者入住ICU; 2. 入科时GCS分级小于8分; 3. 年龄18岁以上; 4. 气管插管或呼吸机辅助通气,预计时间超过7天; 

Inclusion criteria

1. Patients with brain injury or cerebral hemorrhage were admitted to ICU; 2. The grade of GCS was less than 8 at admission; 3. Age above 18 years old; 4. Endotracheal intubation or ventilator-assisted ventilation is expected to last more than 7 days. 

排除标准:

排除标准 1. 急慢性肝衰竭,肾衰竭患者,心功能不全; 2. 严重免疫力低下 3. 孕妇、哺乳期; 4. 癌症患者; 

Exclusion criteria:

1. Acute and chronic liver failure, renal failure, cardiac insufficiency; 2. Severe immunodeficiency; 3. Pregnant women and lactation period; 4. Cancer patients. 

研究实施时间:

Study execute time:

From2019-01-07To 2020-12-31 

干预措施:

Interventions:

组别:

益生菌组

样本量:

50

Group:

Probiotics group

Sample size:

干预措施:

常乐康(酪酸梭菌二联活菌胶囊),3粒,po,bid

干预措施代码:

Intervention:

Changle Kang (Clostridium butyricum combined viable capsule), 3 grains, po, bid

Intervention code:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

中国科学技术大学附属第一院 

单位级别:

省级三甲医院 

Institution
hospital:

The First Affiliated Hospital of University of Science and Technology of China  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

下呼吸道微生态

指标类型:

主要指标 

Outcome:

Lower respiratory Microecology

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道微生态

指标类型:

主要指标 

Outcome:

Intestinal Microecology

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

各种免疫指标

指标类型:

主要指标 

Outcome:

Various immune indicators

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病严重程度

指标类型:

主要指标 

Outcome:

Disease severity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸机相关性肺炎发生率

指标类型:

主要指标 

Outcome:

Incidence of ventilator-associated pneumonia

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

预后

指标类型:

主要指标 

Outcome:

prognosis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸道代谢组学

指标类型:

主要指标 

Outcome:

Respiratory metabonomics

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:

标本中文名:

痰液

组织:

Sample Name:

sputum

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

口腔分泌物

组织:

Sample Name:

Oral secretions

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

支气管肺泡灌洗液

组织:

Sample Name:

bronchoalveolar lavage fluid

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

大便

组织:

Sample Name:

Faeces

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):

随机数表法

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

random number table method

盲法:

双盲:试验者与受试者都不清楚所服用的究竟是试验药还是对照安慰剂。

Blinding:

Double blind Neither the experimenters nor the subjects knew whether they were taking the test drug or the control placebo.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验完成后6个月内以报告形式公开

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

Make public in the form of a report within 6 months after completion of the test

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

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-01-11
返回列表