今天是:2019-04-22 星期一

呋塞米不同使用方案对肾病综合征水肿治疗效果评估
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注册号:

Registration number:

ChiCTR1900022533 

最近更新日期:

Date of Last Refreshed on:

2019-04-15 

注册时间:

Date of Registration:

2019-04-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

呋塞米不同使用方案对肾病综合征水肿治疗效果评估 

Public title:

Evaluating the effect of different regimens of furosemide on edema in patients with nephrotic syndrome  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

呋塞米不同使用方案对肾病综合征水肿治疗效果评估 

Scientific title:

Evaluating the effect of different regimens of furosemide on edema in patients with nephrotic syndrome  

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:

周添标 

研究负责人:

周添标 

Applicant:

Tianbiao Zhou 

Study leader:

Tianbiao Zhou 

申请注册联系人电话:

Applicant telephone:

+86 13670402516 

研究负责人电话:

Study leader's telephone:

+86 13670402516 

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:

zhoutb@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

zhoutb@aliyun.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:

广东省汕头市金平区东厦北路69号 

研究负责人通讯地址:

广东省汕头市金平区东厦北路69号 

Applicant address:

69 Dongsha Road North, Jinping District, Shantou, Guangdong 

Study leader's address:

69 Dongsha Road North, Jinping District, Shantou, Guangdong 

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:

汕头大学医学院第二附属医院 

Applicant's institution:

the Second Affiliated Hospital of Shantou University Medical College 

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:

汕头大学医学院第二附属医院 

Primary sponsor:

the Second Affiliated Hospital of Shantou University Medical College 

研究实施负责(组长)单位地址:

广东省汕头市金平区东厦北路69号 

Primary sponsor's address:

69 Dongsha Road North, Jinping District, Shantou, Guangdong 

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):

汕头

Country:

China

Province:

Guangdong

City:

Shantou

单位(医院):

汕头大学医学院第二附属医院

具体地址:

金平区东厦北路69号

Institution
hospital:

the Second Affiliated Hospital of Shantou University Medical College

Address:

69 Dongsha Road North, Jinping District

经费或物资来源:

汕头大学医学院第二附属医院临床建设经费 

Source(s) of funding:

Funding for clinical construction of the Second Affiliated Hospital of Shantou University Medical College  

研究疾病:

肾病综合征 

Target disease:

Nephrotic Syndrome 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

评估速尿不同使用方案对利尿效果的评价 

Objectives of Study:

Evaluate the effect of different schemes of diuretic using furosemide 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

符合肾病综合征诊断标准的原发性肾病综合征。 

Inclusion criteria

Nephrotic syndrome in line with the diagnostic criteria of primary nephrotic syndrome 

排除标准:

糖尿病肾病、多发性骨髓瘤肾损害、狼疮性肾炎、乙肝相关性肾病、紫癜性肾炎、急性肾小球肾炎等。 

Exclusion criteria:

Diabetic nephropathy, multiple myeloma kidney damage, lupus nephritis, hepatitis B-related nephropathy, purpuric nephritis, acute glomerulonephritis and so on. 

研究实施时间:

Study execute time:

From2019-05-01To 2022-04-30 

干预措施:

Interventions:

组别:

1

样本量:

30

Group:

1

Sample size:

干预措施:

呋塞米, 80mg, i.v., q.d

干预措施代码:

Intervention:

Furosemide, 80mg, i.v., q.d

Intervention code:

组别:

2

样本量:

30

Group:

2

Sample size:

干预措施:

呋塞米, 40mg, i.v., b.i.d

干预措施代码:

Intervention:

Furosemide, 40mg, i.v., b.i.d

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

汕头 

Country:

China 

Province:

Guangdong 

City:

Shantou 

单位(医院):

汕头大学医学院第二附属医院 

单位级别:

三甲 

Institution
hospital:

the Second Affiliated Hospital of Shantou University Medical College  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

尿量

指标类型:

主要指标 

Outcome:

Urine volume

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

body weight

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 15 years
最大 Max age 99 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):

电脑随机数据表 (周添标医师:请补充说明何人使用电脑产生随机数字表,使用何种软件产生)

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

Computer random data sheet

盲法:

open

Blinding:

open

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

论文形式

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

Paper form

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:

Case Record Form

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:

 2019-04-15
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