Today is 2019-12-14

Observational cohort database of kidney diseases v1.0
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注册号:

Registration number:

ChiCTR1900024926 

最近更新日期:

Date of Last Refreshed on:

2019-08-03 

注册时间:

Date of Registration:

2019-08-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肾脏疾病观察性队列数据库v1.0 

Public title:

Observational cohort database of kidney diseases v1.0 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肾脏疾病观察性队列数据库v1.0 

Scientific title:

Observational cohort database of kidney diseases v1.0 

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:

任松 

研究负责人:

洪大情 

Applicant:

Ren Song 

Study leader:

Hong Daqing 

申请注册联系人电话:

Applicant telephone:

+86 18615792543 

研究负责人电话:

Study leader's telephone:

+86 18981838230 

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:

359565403@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

hongdaqing11@126.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:

四川省成都市青羊区一环路西二段32号 

研究负责人通讯地址:

四川省成都市青羊区一环路西二段32号 

Applicant address:

32 West Second Section, First Ring Road, Chengdu, Sichuan, China 

Study leader's address:

32 West Second Section, First Ring Road, Chengdu, Sichuan, 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:

四川省人民医院 

Applicant's institution:

Sichuan Provincial People's Hospital 

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:

伦审(研)2019年196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:

四川省医学科学院.四川省人民医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-06 

伦理委员会联系人:

雍正平 

Contact Name of the ethic committee:

Yong Zhengping 

伦理委员会联系地址:

四川省成都市青羊区一环路西二段32号 

Contact Address of the ethic committee:

32 West Second Section, First Ring Road, Chengdu, Sichuan, 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:

四川省医学科学院.四川省人民医院 

Primary sponsor:

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital 

研究实施负责(组长)单位地址:

四川省成都市青羊区一环路西二段32号 

Primary sponsor's address:

32 West Second Section, First Ring Road, Chengdu, Sichuan, 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):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川省人民医院

具体地址:

四川省成都市青羊区一环路西二段32号

Institution
hospital:

Sichuan Provincial People's Hospital

Address:

32 West Second Section, First Ring Road, Chengdu, Sichuan, China

经费或物资来源:

科室经费 

Source(s) of funding:

Funding comes from Nephrology 

研究疾病:

肾脏病 

Target disease:

kidney diseases 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

系统收集慢性肾脏病患者在肾脏病治疗过程中的医疗信息,提供疾病分布特征及合并症特点,分析治疗现状,了解临床转归,并分析疾病特征、治疗方式与患者预后的关系,优化诊疗方案,为新的临床研究设计提供重要参考价值。 

Objectives of Study:

Systematically collect the medical information of chronic kidney disease patients in the course of kidney disease treatment, provide the characteristics of disease distribution and complications, analyze the treatment status, understand the clinical outcome, and analyze the relationship between disease characteristics, treatment methods and patients'prognosis, optimize the diagnosis and treatment program, provide important reference value for new clinical research design. Value. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

获得患者知情同意的慢性肾脏病患者,包括慢性肾脏病非透析病人,血液透析及腹膜透析患者。 

Inclusion criteria

The patients with chronic kidney disease who sign informed consent, including non-dialysis patients with chronic kidney disease, hemodialysis and peritoneal dialysis patients. 

排除标准:

No 

Exclusion criteria:

No 

研究实施时间:

Study execute time:

From2019-07-31To 2039-07-30 

干预措施:

Interventions:

组别:

Case series

样本量:

50000

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

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):

四川省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Provincial People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

采集人体标本:

Collecting sample(s)
from participants:

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 65 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):

无需随机化

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 ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

拟于试验完成后6个月内在四川省人民医院肾内科官网上公开原始数据,网址:https://www.samsph.com/sneik/

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

The original data will be published on the official website of Renal Medicine Department of Sichuan People's Hospital within 6 months after the completion of the experiment at https://www.samsph.com/s

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:

建立患者随访数据表采集数据,通过REDcap进行数据管理

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

Establish patient follow-up data table to collect data and manage data through REDcap

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-03
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