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维持性血液透析患者心理状态与毒素代谢的相关性研究
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注册号:

Registration number:

ChiCTR1900028275 

最近更新日期:

Date of Last Refreshed on:

2019-12-17 

注册时间:

Date of Registration:

2019-12-17 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

维持性血液透析患者心理状态与毒素代谢的相关性研究 

Public title:

Study for the relationship between mental state and toxin metabolism in maintenance hemodialysis patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

维持性血液透析患者心理状态与毒素代谢的相关性研究 

Scientific title:

Study for the relationship between mental state and toxin metabolism in maintenance hemodialysis patients 

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:

马绍骏 

研究负责人:

丁峰 

Applicant:

Ma Shaojun 

Study leader:

Ding Feng 

申请注册联系人电话:

Applicant telephone:

+86 15221412407 

研究负责人电话:

Study leader's telephone:

+86 15802100898 

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:

mashj@163.com 

研究负责人电子邮件:

Study leader's E-mail:

mashj@shsmu.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:

上海市制造局路639号 

研究负责人通讯地址:

上海市制造局路639号 

Applicant address:

639 Zhi-Zao-Ju Road, Huangpu District, Shanghai, China 

Study leader's address:

639 Zhi-Zao-Ju Road, Huangpu District, Shanghai, 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:

上海交通大学医学院附属第九人民医院肾脏内科 

Applicant's institution:

Department of Nephrology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine 

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:

SH9H-2019-T143-1 

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:

上海交通大学医学院附属第九人民医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-09 

伦理委员会联系人:

刘墨池 

Contact Name of the ethic committee:

Liu Mochi 

伦理委员会联系地址:

上海市制造局路639号 

Contact Address of the ethic committee:

639 Zhi-Zao-Ju Road, Huangpu District, Shanghai, 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:

上海交通大学医学院附属第九人民医院 

Primary sponsor:

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine 

研究实施负责(组长)单位地址:

上海市制造局路639号 

Primary sponsor's address:

639 Zhi-Zao-Ju Road, Huangpu District, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

课题经费 

Source(s) of funding:

Research funding 

研究疾病:

维持性血透 

Target disease:

Maintenance Hemodialysis 

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:

本课题的研究目的对MHD患者所存在心理状态的多方面评估,探讨适合MHD人群心理评估的有效方法,以及不同心理状态与吲哚类蛋白结合毒素水平的相关性,为寻求改善MHD患者诊治疗效,提高其生活质量寻求理论依据。 

Objectives of Study:

The purpose of this study is to evaluate the mental state of MHD patients in many aspects, to explore the effective methods for mental assessment of MHD population, and to explore the correlation between different mental states and the level of indole protein binding toxin, in order to seek for the theoretical basis for improving the diagnosis and treatment effect of MHD patients and improving their quality of life. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

1)年龄≥18岁; 2)签署知情同意书。 

Inclusion criteria

1. Aged >=18 years; 2. sign informed consent. 

排除标准:

1)留置导管; 2)未治疗的恶性肿瘤; 3)认知功能障碍; 4)不能配合完成量表; 5)临床资料不完整的。 

Exclusion criteria:

1. Indwelling catheter; 2. untreated malignant tumor; 3. cognitive dysfunction; 4. unable to complete the scale; 5. incomplete clinical data. 

研究实施时间:

Study execute time:

From2019-05-01To 2020-04-30 

征募观察对象时间:

Recruiting time:

From2019-10-10To 2020-01-31 

干预措施:

Interventions:

组别:

Case series

样本量:

200

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):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属第九人民医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

心理量表得分

指标类型:

主要指标 

Outcome:

the score of mental scales

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

No. 收集上海交通大学医学院附属第九人民医院血透中心所有符合纳入标准和排除标准进行维持性血透的成年患者

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

No. Selected adult patients who met the inclusion criteria and exclusion criteria for maintenance hemodialysis in the hemodialysis center of the Ninth People's Hospital Affiliated to Shanghai Jiaotong University Medical College.

盲法:

No

Blinding:

No

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):

ResMan临床试验公共管理平台

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

ResMan(www.medresman.org)

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:

http://evigate.cn/data

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

http://evigate.cn/data

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-12-17
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