Today is 2022-01-23

Circulating markers in Diagnosis and Prognosis of Pediatric Sepsis Induced Cardiomyopathy
download

注册号:

Registration number:

ChiCTR2200055641 

最近更新日期:

Date of Last Refreshed on:

2022-01-15 

注册时间:

Date of Registration:

2022-01-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

循环标志物在儿童脓毒性心肌病诊断及预后的价值 

Public title:

Circulating markers in Diagnosis and Prognosis of Pediatric Sepsis Induced Cardiomyopathy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

循环标志物在儿童脓毒性心肌病诊断及预后的价值 

Scientific title:

Circulating markers in Diagnosis and Prognosis of Pediatric Sepsis Induced Cardiomyopathy 

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:

陈唐田 

研究负责人:

许皓 

Applicant:

Chen Tangtian 

Study leader:

Xu Hao 

申请注册联系人电话:

Applicant telephone:

+8618084012154 

研究负责人电话:

Study leader's telephone:

+8613594028670 

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:

461524834@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xuhao@hospital.cqmu.edu.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:

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 Zhongshan Second Road, Yuzhong District, Chongqing  

Study leader's address:

136 Zhongshan Second 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:

(2021)年伦审(研)第(353)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:

重庆医科大学儿童医院医学研究伦理委员会 

Name of the ethic committee:

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:

2021-11-23 

伦理委员会联系人:

肖琦 

Contact Name of the ethic committee:

Xiao Qi 

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 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+862363664659 

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 Zhongshan Second Road, Yuzhong District, Chongqing  

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 Zhongshan Second Road, Yuzhong District

经费或物资来源:

单位自筹 

Source(s) of funding:

self-raised 

研究疾病:

脓毒性心肌病 

Target disease:

Sepsis Induced Cardiomyopathy 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

评估循环标记物在脓毒性心肌病患儿中的早期诊断价值,分析循环标记物在脓毒性心肌病患儿病情严重程度和预后评估中的价值。 

Objectives of Study:

To evaluate the early diagnostic value of circulating markers in children with septic cardiomyopathy, and to analyze the value of circulating markers in the evaluation of the severity and prognosis of children with septic cardiomyopathy. 

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:

1.年龄1月-18岁; 2.符合sepsis 3.0诊断标准。 

Inclusion criteria

1. Aged 1 month to 18 years; 2. According to the diagnostic criteria of sepsis 3.0. 

排除标准:

1.心肌细胞损伤或缺血性心肌疾病; 2.先天性心脏病; 3.特异性心肌病; 4.心肌炎; 5.川崎病; 6.终末肾病; 7.心胸外伤; 8.14天内有心肺复苏病史; 9.乳酸代谢相关性疾病; 10.特发性心律失常。 

Exclusion criteria:

1.Cardiomyocyte damage or ischemic myocardial disease; 2.Congenital heart disease; 3.Specific cardiomyopathy; 4.Myocarditis; 5.Kawasaki disease; 6.End-stage renal disease; 7.Cardiothoracic trauma; 8.A history of cardiopulmonary resuscitation within 14 days; 9.Diseases related to lactic acid metabolism; 10.Idiopathic arrhythmia. 

研究实施时间:

Study execute time:

From2022-01-12To 2023-01-12 

征募观察对象时间:

Recruiting time:

From2022-01-20To 2022-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

50

Group:

Control group

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

组别:

脓毒症组

样本量:

50

Group:

Sepsis group

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

组别:

脓毒性心肌病组

样本量:

50

Group:

Sepsis Induced Cardiomyopathy 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 

测量指标:

Outcomes:

指标中文名:

循环标志物

指标类型:

主要指标 

Outcome:

Circulating markers

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

使用后保存 

说明

Fate of sample:

Preservation 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 0 years
最大 Max age 18 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):

No

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

No

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

以论文方式公开

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

Open in the form of papers

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:

病例记录表以及血液检测结果

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

Case records and blood test results

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2022-01-15
return list