今天是:2019-12-14 星期六

基于真实世界数据探讨万古霉素血药浓度达标的影响因素
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注册号:

Registration number:

ChiCTR1900024062 

最近更新日期:

Date of Last Refreshed on:

2019-06-23 

注册时间:

Date of Registration:

2019-06-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于真实世界数据探讨万古霉素血药浓度达标的影响因素 

Public title:

A real world study for factors impact concentration of vancomycin in blood reaching the standard 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于真实世界数据探讨万古霉素血药浓度达标的影响因素 

Scientific title:

A real world study for factors impact concentration of vancomycin in blood reaching the standard 

研究课题代号(代码):

Study subject ID:

(2014)181; YWJKJJHKYJJ-B183073 

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:

陈海琴 

研究负责人:

石庆平 

Applicant:

Chen Haiqin 

Study leader:

Shi Qingping 

申请注册联系人电话:

Applicant telephone:

+86 13155201763 

研究负责人电话:

Study leader's telephone:

+86 0552 3086246 

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:

2251202943@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

sir_shi@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:

安徽省蚌埠市龙子湖区长淮路287号 

研究负责人通讯地址:

安徽省蚌埠市龙子湖区长淮路287号 

Applicant address:

287 Changhuai Road, Longzihu District, Handan, Anhui, China 

Study leader's address:

287 Changhuai Road, Longzihu District, Handan, Anhui, China 

申请注册联系人邮政编码:

Applicant postcode:

233000 

研究负责人邮政编码:

Study leader's postcode:

233000 

申请人所在单位:

蚌埠医学院 

Applicant's institution:

Bengbu Medical College 

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:

2018xy008 

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:

临床医学研究伦理委员会 

Name of the ethic committee:

Clinical Medical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-08-08 

伦理委员会联系人:

金世洋 

Contact Name of the ethic committee:

Jin Shiyang 

伦理委员会联系地址:

安徽省蚌埠市龙子湖区长淮路287号 

Contact Address of the ethic committee:

287 Changhuai Road, Longzihu District, Handan, Anhui, 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:

蚌埠医学院第一附属医院 

Primary sponsor:

First Affiliated Hospital of Bengbu Medical College 

研究实施负责(组长)单位地址:

安徽省蚌埠市龙子湖区长淮路287号 

Primary sponsor's address:

287 Changhuai Road, Longzihu District, Handan, Anhui, 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):

安徽省

市(区县):

蚌埠市

Country:

China

Province:

Anhui

City:

Bengbu

单位(医院):

蚌埠医学院第一附属医院

具体地址:

安徽省蚌埠市龙子湖区长淮路287号

Institution
hospital:

First Affiliated Hospital of Bengbu Medical College

Address:

287 Changhuai Road, Longzihu District, Handan, Anhui, China

经费或物资来源:

安徽省教育厅2014年度高等教育振兴计划人才项目[皖教秘人[2014]181号];北京医卫健康基金,项目名称:基于群体药代动力学模型的个体化用药指导[YWJKJJHKYJJ-B183073] 

Source(s) of funding:

Anhui Provincial Department of Education 2014 Higher Education Revitalization Program Talent Project [Teac[2014]181]; Beijing Medical Health Fund, Project Name: Individualized medication guidance base 

研究疾病:

感染 

Target disease:

infection 

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:

探讨万古霉素血药浓度达标率的影响因素,建立万古霉素血药浓度预测方程,为万古霉素个体化应用提供参考依据。 

Objectives of Study:

To explore the influencing factors of vancomycin blood concentration compliance rate, establish the prediction equation of vancomycin blood concentration, and provide reference for the individual application of vancomycin. 

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临床治疗过程中使用了万古霉素用于治疗患者感染并进行过万古霉素血药浓度监测;②收集数据为患者万古霉素血药浓度的谷浓度,而非峰浓度或给药后立即监测的浓度;③对照组的影响因素与观察组涉及的影响因素一致。 

Inclusion criteria

1. Clinical treatment used vancomycin for the treatment of patients with infection and monitoring of vancomycin blood concentration; 2. data collected for the concentration of vancomycin blood concentration, not peak concentration or immediately after administration The monitored concentration; 3. the influencing factors of the control group were consistent with the influencing factors involved in the observation group. 

排除标准:

无 

Exclusion criteria:

No 

研究实施时间:

Study execute time:

From2018-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

达标组和未达标组

样本量:

168

Group:

standard group versus non-standard group

Sample size:

干预措施:

No

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):

安徽省 

市(区县):

蚌埠市 

Country:

China 

Province:

Anhui 

City:

Bengbu 

单位(医院):

蚌埠医学院第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital of Bengbu Medical College  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血药浓度

指标类型:

主要指标 

Outcome:

Blood concentration

Type:

Primary indicator 

测量时间点:

使用万古霉素后4至5个半衰期

测量方法:

Measure time point of outcome:

4 to 5 half-lives after vancomycin

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 1 years
最大 Max age 88 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):

N/A

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):

点击下载

Calculated Results after
the Study Completed(upload file):

download

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):

本研究收集的数据于2020年1月1日在 ResMan 临床试验公共平台 Clinical Trial Management Public Platform 共享

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

The data collected in this study was shared on the ResMan Clinical Trial Public Platform Clinical Trial Management Public Platform on January 1, 2020.

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:

病例记录表根据医院的HIS系统收集相关数据,收集过程中需保持数据的及时、完整和准确,对收集到的数据需进行复核,防止错漏,对数据进行编码,最终录入数据库。对所有存储数据文件的介质妥善保存管理。

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

The case record table collects relevant data according to the hospital's HIS system. The data needs to be kept timely, complete and accurate during the collection process. The collected data needs to be reviewed to prevent errors and omissions, the data is encoded, and finally entered into the database. Save and manage all media that store data files.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-23
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