今天是:2018-01-19 星期五

延迟相远端缺血预处理应用于亲属活体肾移植手术的临床研究
下载XML文档

注册号:

Registration number:

ChiCTR-IOR-16008826 

最近更新日期:

Date of Last Refreshed on:

2016-07-12 

注册时间:

Date of Registration:

2016-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

延迟相远端缺血预处理应用于亲属活体肾移植手术的临床研究 

Public title:

Clinical research of delayed remote ischemic preconditioning on living-related donor kidney transplantation  

研究课题的正式科学名称:

延迟相远端缺血预处理对亲属活体肾移植手术患者术后肾功能早期恢复的影响 

Scientific title:

Effects of delayed remote ischemic preconditioning on graft fuction in patients undergoing living-related donor kidney transplantation  

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:

高亚利 

研究负责人:

李娟 

Applicant:

Gao yali 

Study leader:

Li juan 

申请注册联系人电话:

Applicant telephone:

+86 13955158523 

研究负责人电话:

Study leader's telephone:

+86 13956005465 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 551-62284189 

申请注册联系人电子邮件:

Applicant E-mail:

13955158523@139.com 

研究负责人电子邮件:

Study leader's E-mail:

huamuzi1999@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:

安徽省合肥市庐江路17号 

研究负责人通讯地址:

安徽省合肥市政务文化新区天鹅湖路1号 

Applicant address:

17 Lujiang Road, Hefei, China  

Study leader's address:

1 Swan Lake Rd, Hefei, Anhui, China  

申请注册联系人邮政编码:

Applicant postcode:

230001 

研究负责人邮政编码:

Study leader's postcode:

230036 

申请人所在单位:

安徽省立医院 

Applicant's institution:

Anhui Provincial Hospital  

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:

2016-20 

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:

安徽省立医院临床医学研究伦理委员会 

Name of the ethic committee:

clinical medical research ethics committee of anhui provincial hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2016-05-30 

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:

安徽省立医院 

Primary sponsor:

Anhui Provincial Hospital  

研究实施负责(组长)单位地址:

安徽省合肥市政务文化新区天鹅湖路1号 

Primary sponsor's address:

1 Swan Lake Rd, Hefei, 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

市(区县):

合肥

Country:

China

Province:

Anhui

City:

Hefei

单位(医院):

安徽省立医院

具体地址:

安徽省合肥市庐江路17号

Institution
hospital:

Anhui Provincial Hospital

Address:

17 Lujiang Road, Hefei, China

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

活体肾移植 

Target disease:

live kidney transplantation 

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:

其它 

Study phase:

Other 

研究目的:

探讨延迟相远端缺血预处理对亲属活体肾移植手术患者术后肾功能早期恢复的影响 

Objectives of Study:

To investigate the effects of delayed remote ischemic preconditioning on graft fuction in patients undergoing living-related donor kidney transplantation  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1.择期行亲属活体肾移植手术的患者 2.年龄≥18岁 

Inclusion criteria

1. Patients scheduled for elective living-related donor kidney transplantation; 2. Patients aged ≥18 years. 

排除标准:

1.年龄<18岁 2.紧急手术 3.存在外周缺血性血管疾病影响到上肢功能的患者 4.既往有器官移植史 5.需要进行人类白细胞抗原(HLA)抗体清除治疗的患者 

Exclusion criteria:

1. Emergency surgery; 2. Patients with peripheral ischemic vascular disease that involved the upper limb; 3. Patients who had history of solid organ transplantation; 4. Any patient requiring human leucocyte antigen (HLA) antibody removal therapy. 

研究实施时间:

Study execute time:

From2016-08-01To  

干预措施:

Interventions:

组别:

实验组

样本量:

30

Group:

experimental group

Sample size:

干预措施:

术前24h在受体和供体上肢绑血压计袖带,充气至压力200mmHg,持续5min,随之放气5min,做3个循环

干预措施代码:

Intervention:

Placing a blood pressure cuff on the upper arm of both the donor and recipient for three inflating–deflating cycles 24 hours before surgery: 5 min inflating to 200 mmHg followed by a 5-min reperfusion with deflating the cuff.

Intervention code:

组别:

对照组

样本量:

30

Group:

control

Sample size:

干预措施:

术前24h在受体和供体上肢绑血压计袖带,不充气,持续30min

干预措施代码:

Intervention:

Placing an uninflated cuff of on the upper arm of both the donor and recipient for 30 min 24 hours before surgery

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽省立医院 

单位级别:

三级甲等 

Institution
hospital:

Anhui Provincial Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血清肌酐水平

指标类型:

主要指标 

Outcome:

serum creatinine

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清NGAL水平

指标类型:

主要指标 

Outcome:

serum NGAL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿液NGAL水平

指标类型:

主要指标 

Outcome:

urine NGAL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿液IL-18水平

指标类型:

主要指标 

Outcome:

urine IL-18

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

丙二醛

指标类型:

主要指标 

Outcome:

MDA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超氧化物岐化酶活性

指标类型:

主要指标 

Outcome:

SOD

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后并发症

指标类型:

次要指标 

Outcome:

postoperative complications

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:

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:

标本中文名:

尿液

组织:

Sample Name:

Urine

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 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):

通过计算机产生随机数字表进行随机化分组

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

Classify groups via random number table with computer

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):

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):

论文发表后公布研究数据

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

After paper published, we will disclose data for the public

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:

excel表格

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

excel table

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-07-12
返回列表