MANF对脓毒症肺损伤的分子诊断价值及调控内质网应激影响脓毒症肺损伤转归的作用及机制研究

注册号:

Registration number:

ChiCTR2200060529 

最近更新日期:

Date of Last Refreshed on:

2023-03-18 21:15:50 

注册时间:

Date of Registration:

2022-06-04 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

MANF对脓毒症肺损伤的分子诊断价值及调控内质网应激影响脓毒症肺损伤转归的作用及机制研究

Public title:

Molecular diagnostic value of MANF on lung injury in sepsis and its role in regulating endoplasmic reticulum stress affecting the outcome of lung injury in sepsis and its mechanism

注册题目简写:

English Acronym:

研究课题的正式科学名称:

MANF对脓毒症肺损伤的分子诊断价值及调控内质网应激影响脓毒症肺损伤转归的作用及机制研究

Scientific title:

Molecular diagnostic value of MANF on lung injury in sepsis and its role in regulating endoplasmic reticulum stress affecting the outcome of lung injury in sepsis and its mechanism

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:

汪建文 

研究负责人:

周琰 

Applicant:

Wang Jianwen 

Study leader:

Zhou Yan 

申请注册联系人电话:

Applicant telephone:

+86 13708068948

研究负责人电话:

Study leader's
telephone:

+86 18980605705

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:

799909495@qq.com

研究负责人电子邮件:

Study leader's E-mail:

zhouyanhxicu@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:

四川省成都市武侯区国学巷37号

研究负责人通讯地址:

四川省成都市武侯区国学巷37号

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan

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:

四川大学华西医院

Applicant's institution:

West China Hospital of Sichuan University

研究负责人所在单位:

四川大学华西医院

Affiliation of the Leader:

West China Hospital of Sichuan University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2022年审(710)号

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:

四川大学华西医院生物医学伦理审查委员会

Name of the ethic committee:

Biomedical Ethics Review Committee of West China Hospital, Sichuan University

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 00:00:00

伦理委员会联系人:

陈诗琦

Contact Name of the ethic committee:

Chen Shiqi

伦理委员会联系地址:

四川省成都市武侯区国学巷37号

Contact Address of the ethic committee:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan

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:

四川大学华西医院

Primary sponsor:

West China Hospital of Sichuan University

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan

经费或物资来源:

成都市科技局

Source(s) of funding:

Chengdu Science and Technology Bureau

研究疾病:

脓毒症  

Target disease:

Sepsis

研究疾病代码:

Target disease code:

研究类型:

基础科学研究

Study type:

Basic Science

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

本项目拟系统全面研究MANF蛋白与脓毒症肺损伤疾病进展的关系,探明MANF在脓毒症肺损伤中的分子诊断价值;并以内质网应激介导细胞凋亡为核心,研究重组人MANF对LPS脓毒症小鼠肺损伤转归的影响及分子机制,为开拓MANF作为早期诊断、治疗脓毒症肺损伤的新途径提供了很好的思路和方法。  

Objectives of Study:

This project intends to systematically and comprehensively study the relationship between MANF protein and the progression of septic lung injury, and to explore the molecular diagnostic value of MANF in septic lung injury. The effect and molecular mechanism of human MANF on the outcome of lung injury in LPS mice with sepsis provides a good idea and method for developing MANF as a new way of early diagnosis and treatment of septic lung injury.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1. 年龄小于18岁的患者。

Exclusion criteria:

1. Patients younger than 18 years old.

研究实施时间:

Study execute time:

From 2022-05-25 00:00:00 To 2022-08-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2022-05-25 00:00:00 To 2022-08-31 00:00:00

干预措施:

Interventions:

组别:

脓毒症组

样本量:

20

Group:

Sepsis group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

四川 

市(区县):

成都 

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital of Sichuan University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

中脑星形胶质细胞源性神经营养因子

指标类型:

主要指标

Outcome:

Midbrain astrocyte-derived neurotransmitter trophic factor

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 100 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):

由研究者根据患者SOFA评分,生命体征和血液检查结果分组

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

Patients were grouped by investigator based on SOFA score, vital signs, and blood test results

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

Blinding:

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):

试验结束一年后上传到临床试验公共管理平台ResMan

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

Uploaded to ResMan, a public management platform for clinical trials, one year after the trial ends

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:

病例记录表和医院电子信息系统

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

Case record forms and hospital electronic information systems

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-06-04 17:22:44