连续肾脏替代治疗中影响管路寿命的原因分析

注册号:

Registration number:

ChiCTR-RCH-11001281 

最近更新日期:

Date of Last Refreshed on:

2015-07-11 10:33:30 

注册时间:

Date of Registration:

2011-04-19 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

连续肾脏替代治疗中影响管路寿命的原因分析

Public title:

Variables that influence the circuit life span in patients undergoing continuous renal replacement therapy

注册题目简写:

English Acronym:

研究课题的正式科学名称:

连续肾脏替代治疗中影响管路寿命的原因分析

Scientific title:

Variables that influence the circuit life span in patients undergoing continuous renal replacement therapy

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:

章仲恒 

研究负责人:

章仲恒 

Applicant:

Zhongheng Zhang 

Study leader:

Zhongheng Zhang 

申请注册联系人电话:

Applicant telephone:

+86 579 82552629

研究负责人电话:

Study leader's
telephone:

+86 579 82552629

申请注册联系人传真 :

Applicant Fax:

+86 579 82552629

研究负责人传真:

Study leader's fax:

+86 579 82552629

申请注册联系人电子邮件:

Applicant E-mail:

zh_zhang1984@hotmail.com

研究负责人电子邮件:

Study leader's E-mail:

zh_zhang1984@hotmail.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.jhzxyy.cn/zxyy/

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.jhzxyy.cn/zxyy/

申请注册联系人通讯地址:

浙江省金华市明月街351号,重症医学科

研究负责人通讯地址:

省金华市明月街351号,重症医学科

Applicant address:

351 Mingyue Road, Jinhua, Zhejiang, China

Study leader's address:

351 Mingyue Road, Jinhua, Zhejiang, China

申请注册联系人邮政编码:

Applicant postcode:

321000

研究负责人邮政编码:

Study leader's postcode:

321000

申请人所在单位:

金华市中心医院

Applicant's institution:

Jinhua Municipal Central Hospital

研究负责人所在单位:

Affiliation of the Leader:

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:

2010-05(01)

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

金华市中心医院医学伦理委员会

Name of the ethic committee:

Ethics Committee of Jinhua Municipal Central Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2010-05-25 00:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

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:

金华市中心医院

Primary sponsor:

Jinhua Municipal Central Hospital

研究实施负责(组长)单位地址:

浙江省金华市明月街351号

Primary sponsor's address:

351 Mingyue Road, Jinhua, Zhejiang, 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):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

金华市中心医院

具体地址:

浙江省金华市明月街351号

Institution
hospital:

Jinhua Municipal Central Hospital

Address:

351 Mingyue Road, Jinhua, Zhejiang, China

经费或物资来源:

自筹

Source(s) of funding:

Self-funding

研究疾病:

急性肾功能衰竭  

Target disease:

Acute kidney injury

研究疾病代码:

N17

Target disease code:

N17

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:

探索性研究/预试验 

Study phase:

0

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

连续肾脏替代治疗中影响管路寿命的原因分析  

Objectives of Study:

To study the variables that influence the circuit life span in patients undergoing continuous renal replacement therapy.

药物成份或治疗方案详述:

无试验用药 无 

Description for medicine or protocol of treatment in detail:

no drug intervention none 

纳入标准:

Inclusion criteria

排除标准:

1、妊娠;
2、有凝血系统疾病

Exclusion criteria:

1. Pregnant;
2. Preexistent coagulopathy.

研究实施时间:

Study execute time:

From 2010-07-01 00:00:00 To 2011-10-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2010-07-01 00:00:00 To 2011-10-31 00:00:00

干预措施:

Interventions:

组别:

A组

样本量:

50

Group:

Group A

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):

浙江 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

金华市中心医院 

单位级别:

三级甲等医院 

Institution
hospital:

Jinhua Municipal Central Hospital

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

管路寿命

指标类型:

主要指标

Outcome:

Circuit life spa

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:

征募研究对象情况:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

计算机软件

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

computer generation

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

金华市中心医院

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

Jinhua Municipal Central Hospital

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:

金华市中心医院

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

Jinhua Municipal Central Hospital

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2015-07-11 10:33:30