今天是:2020-08-03 星期一

联用美罗培南引起的丙戊酸血浆浓度下降对其抗癫痫作用的影响
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注册号:

Registration number:

ChiCTR2000034567 

最近更新日期:

Date of Last Refreshed on:

2020-07-10 

注册时间:

Date of Registration:

2020-07-10 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

联用美罗培南引起的丙戊酸血浆浓度下降对其抗癫痫作用的影响 

Public title:

The effect of plasma concentration decline induced by the co-administration of meropenem on the anti-epileptic efficacy of valproic acid 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

美罗培南对丙戊酸抗癫痫效果的影响 

Scientific title:

The effect of meropenem on the antiepileptic effect of valproic acid 

研究课题代号(代码):

Study subject ID:

南方医院院长基金(2019B007) 

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:

王冬梅 

研究负责人:

王胜男 

Applicant:

Dongmei Wang 

Study leader:

Shengnan Wang 

申请注册联系人电话:

Applicant telephone:

+86 13926115696 

研究负责人电话:

Study leader's telephone:

+86 13427564191 

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:

wangdm03@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

wsnpumc@smu.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:

广州市广州大道北1838号南方医院 

研究负责人通讯地址:

广州市广州大道北1838号南方医院 

Applicant address:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, China 

Study leader's address:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510515 

研究负责人邮政编码:

Study leader's postcode:

510515 

申请人所在单位:

南方医科大学南方医院 

Applicant's institution:

Nanfang Hospital, Southern Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

南方医科大学南方医院神经内科 

Primary sponsor:

Neurology Department, Nanfang Hospital, Southern Medical University 

研究实施负责(组长)单位地址:

广州市广州大道北1838号南方医院 

Primary sponsor's address:

Nanfang Hospital, Southern Medical University, 1838 Guangzhou Avenue North, Guangzhou, Guangdong, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医院

具体地址:

广州市广州大道北1838号

Institution
hospital:

Nanfang Hospital

Address:

1838 Guangzhou Avenue North

经费或物资来源:

南方医院院长基金(2019B007) 

Source(s) of funding:

President Fund of Nanfang hospital (No.2019B007) 

研究疾病:

癫痫合并感染 

Target disease:

epilepsy and infection 

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:

探讨联用美罗培南(MEPM)引起的丙戊酸(VPA)血浆浓度下降是否影响VPA的抗癫痫功效。 

Objectives of Study:

To explore whether the decline of plasma concentration of valproic acid (VPA) induced by co-administration of meropenem (MEPM) affect the antiepileptic efficacy of VPA.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1)年龄≥14岁; 2)诊断为癫痫病或癫痫持续状态(SE)。  

Inclusion criteria

1. aged>=14 years old; 2. diagnosed as epilepsy or status epilepticus (SE).  

排除标准:

1)VPA未与MEPM共同使用或共同使用<24h; 2)VPA用于预防癫痫发作; 3)数据丢失(包括癫痫发作记录和/或感染评估)。 

Exclusion criteria:

1. VPA not used concomitantly with MEPM or co-administration for<24h; 2. VPA used for seizure prophylaxis3) data missing (including the record of seizure attacks and/or the assessment of infection). 

研究实施时间:

Study execute time:

From2019-07-01To 2020-07-01 

征募观察对象时间:

Recruiting time:

From2010-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

50

Group:

Case series

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):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医院 

单位级别:

三甲医院 

Institution
hospital:

Nanfang Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

癫痫频率

指标类型:

主要指标 

Outcome:

seizure frequency

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

癫痫持续时间

指标类型:

次要指标 

Outcome:

seizure duration

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

联合用药情况

指标类型:

次要指标 

Outcome:

concomitant AEDs

Type:

Secondary 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 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):

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

not applicable

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:

即时公开/Real time access

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):

发表文章;ResMan, http://www.medresman.org

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

publication; ResMan

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

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-10
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