今天是:2019-08-22 星期四

ghrelin水平在儿童脓毒症诊断与预后价值研究
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注册号:

Registration number:

ChiCTR1900023254 

最近更新日期:

Date of Last Refreshed on:

2019-05-18 

注册时间:

Date of Registration:

2019-05-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

ghrelin水平在儿童脓毒症诊断与预后价值研究 

Public title:

Study for the value of ghrelin level in the diagnosis and prognosis of sepsis in children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

ghrelin水平在儿童脓毒症诊断与预后价值研究 

Scientific title:

Study for the value of ghrelin level in the diagnosis and prognosis of sepsis in children 

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:

袁羞 

研究负责人:

谭利平 

Applicant:

Yuan Xiu 

Study leader:

Tan Lipng 

申请注册联系人电话:

Applicant telephone:

+86 13399873043 

研究负责人电话:

Study leader's telephone:

+86 13677671919 

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:

1375394894@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

tanlp0825@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:

重庆市渝中区中山二路136号 

研究负责人通讯地址:

重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing 

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing 

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:

重庆医科大学附属儿童医院 

Applicant's institution:

Children's Hospital of Chongqing 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:

2015-78 

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:

重庆医科大学附属儿童医院伦理委员会 

Name of the ethic committee:

The Institutional Review Board of Children's Hospital of Chongqing Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2015-07-31 

伦理委员会联系人:

卢仲毅 

Contact Name of the ethic committee:

Lu Zhongyi 

伦理委员会联系地址:

重庆市渝中区中山二路136号 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University  

研究实施负责(组长)单位地址:

重庆市渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属儿童医院

具体地址:

渝中区中山二路136号

Institution
hospital:

Children's Hospital of Chongqing Medical University

Address:

136 Second Zhongshan Road, Yuzhong District

经费或物资来源:

重庆市科学技术委员会 

Source(s) of funding:

ChongQing Science and Technology Commission  

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 

研究目的:

研究急诊及PICU病房患儿血浆Ghrelin的水平及其愈后相关性。 

Objectives of Study:

To study the level of plasma ghrelin and its post-relationship in children in emergency and PICU wards. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

依据sepsis 3.0及《儿童脓毒症休克(感染性休克)诊治专家共识2015版》,设计正常对照组、单纯脓毒症组、脓毒症肺损伤组共3组。以2018年12月至2019年12月入住重庆医科大学附属儿童医院PICU的脓毒症肺损伤患儿为研究对象,另随机选取同期在PICU住院的年龄、性别匹配单纯脓毒症患儿作为单纯脓毒症组,随机选取我院来进行健康体检年龄、性别匹配的儿童作为正常对照组。 

Inclusion criteria

According to sepsis 3. 0 and "2015 consensus of experts on diagnosis and treatment of septic shock in children", 3 groups were designed as normal control group, simple sepsis group and septic lung injury group. From December 2018 to December 2018, children with septic lung injury admitted to PICU affiliated Children's Hospital of Chongqing Medical University were randomly selected as simple sepsis group. Children with age and sex matched for health examination were randomly selected as normal control group. 

排除标准:

排除肝肾疾病、血液系统疾病、肿瘤、先天性心脏病、先天性代谢性疾病、消化道畸形、内分泌系统疾病等基础疾病。 

Exclusion criteria:

Diseases of liver and kidney, blood system, tumor, congenital heart disease, congenital metabolic disease, alimentary tract malformation, endocrine system disease and so on.  

研究实施时间:

Study execute time:

From2019-06-01To 2020-06-01 

干预措施:

Interventions:

组别:

正常对照组、单纯脓毒症组、脓毒症肺损伤组

样本量:

200

Group:

Normal control group, simple sepsis group, septic lung injury group

Sample size:

干预措施:

干预措施代码:

Intervention:

No·

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Children's Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

生长激素释放肽

指标类型:

主要指标 

Outcome:

ghrelin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素-6

指标类型:

主要指标 

Outcome:

IL-6

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高迁移率蛋白1

指标类型:

主要指标 

Outcome:

HMGB1

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤坏死因子-α

指标类型:

主要指标 

Outcome:

TNF-α

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:

外周静脉

Sample Name:

blood

Tissue:

peripheral vein

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 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):

全部PICU儿童脓毒症病例

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

N/A

盲法:

N/A

Blinding:

N/A

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:

即时公开/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):

2020.07.01

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

2020.07.01

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:

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:

Electronic acquisition and management system

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-05-18
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