今天是:2019-08-22 星期四

3%的高渗盐水能降低TBI儿童的死亡率并改善其长期神经系统预后吗?
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注册号:

Registration number:

ChiCTR1900023523 

最近更新日期:

Date of Last Refreshed on:

2019-06-01 

注册时间:

Date of Registration:

2019-06-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

3%的高渗盐水能降低TBI儿童的死亡率并改善其长期神经系统预后吗? 

Public title:

Can 3% hypertonic saline reduce TBI child mortality and improve long-term neurological outcomes? 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

3%的高渗盐水能降低TBI儿童的死亡率并改善其长期神经系统预后吗? 

Scientific title:

Can 3% hypertonic saline reduce TBI child mortality and improve long-term neurological outcomes? 

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:

党红星 

研究负责人:

党红星 

Applicant:

Dang Hongxing 

Study leader:

Dang Hongxing 

申请注册联系人电话:

Applicant telephone:

+86 13647683940 

研究负责人电话:

Study leader's telephone:

+86 13647683940 

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:

dhxdoc@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dhxdoc@163.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:

中国重庆市渝中区中山二路136号 

研究负责人通讯地址:

中国重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

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:

重庆医科大学附属儿童医院 

Applicant's institution:

Children's Hospital of Chongqing Medical University 

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:

(2018)伦审(研)第(176)号 

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:

重庆医科大学附属儿童医院医学研究伦理委员会 

Name of the ethic committee:

Institutional Review Board of Children's Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-14 

伦理委员会联系人:

卢仲毅 

Contact Name of the ethic committee:

Lu Zhongyi 

伦理委员会联系地址:

中国重庆市渝中区中山二路136号 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

中国重庆市渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

self-finance 

研究疾病:

颅脑创伤 

Target disease:

traumatic brain injury 

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:

探索性研究/预试验 

Study phase:

研究目的:

(1)比较使用3%盐水和甘露醇对16岁以下TBI患儿30天死亡风险的影响 (2)比较TBI患儿使用甘露醇和高渗盐在死亡风险和神经系统结局方面的差异,比较哪种做法更能够改善患儿预后。 

Objectives of Study:

(1) to compare the effects of 3% saline and mannitol on the 30-day risk of death in TBI children under 16 years of age (2) to compare the difference in the risk of death and neurological outcome between the use of mannitol and hyperosmolar salt in children with TBI, and to compare which method is more likely to improve the prognosis of children with TBI. 

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:

16岁以下的儿童(除外新生儿)、且颅脑损伤在24小时内ICU、格拉斯哥昏迷评分(GCS)≤13的机械通气患者 

Inclusion criteria

Children under 16 years of age (excluding newborns), with craniocerebral injury within 24 hours of ICU, Glasgow coma score (GCS) 13 with mechanical ventilation patients 

排除标准:

创伤前即已存在神经系统疾病的患者 

Exclusion criteria:

Patients with pre-existing neurological disease. 

研究实施时间:

Study execute time:

From2019-06-01To 2020-05-31 

干预措施:

Interventions:

组别:

Two groups

样本量:

100

Group:

Two groups

Sample size:

干预措施:

3%盐水 vs 甘露醇

干预措施代码:

Intervention:

3% saline versus mannitol

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三甲医院 

Institution
hospital:

Children's Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

格拉斯哥昏迷量表

指标类型:

主要指标 

Outcome:

Glasgow coma scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

损伤严重性评分

指标类型:

主要指标 

Outcome:

Injury severity score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高渗药物使用

指标类型:

主要指标 

Outcome:

Hypertonic drug use

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颅内压(ICP)监测

指标类型:

主要指标 

Outcome:

Intracranial pressure (ICP) monitoring

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:

组织:

Sample Name:

No

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 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):

No

盲法:

N/A

Blinding:

N/A

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:

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):

2021.1.1公开

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

2021.1.1 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:

病例记录表

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

standard data collection

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-06-01
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