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Research for the mechanism of improvement of novel coronavirus pneumonia (COVID-19) patients' pulmonary exudation by continuous renal replacement therapy
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注册号:

Registration number:

ChiCTR2000030540 

最近更新日期:

Date of Last Refreshed on:

2020-03-07 

注册时间:

Date of Registration:

2020-03-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

连续性肾脏替代治疗改善新型冠状病毒肺炎(COVID-19)患者肺部渗出的机制研究 

Public title:

Research for the mechanism of improvement of novel coronavirus pneumonia (COVID-19) patients' pulmonary exudation by continuous renal replacement therapy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

连续性肾脏替代治疗改善新型冠状病毒肺炎(COVID-19)患者肺部渗出的机制研究 

Scientific title:

Research for the mechanism of improvement of novel coronavirus pneumonia (COVID-19) patients' pulmonary exudation by continuous renal replacement therapy 

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:

冉晓 

研究负责人:

李树生 

Applicant:

Ran Xiao 

Study leader:

Li Shusheng 

申请注册联系人电话:

Applicant telephone:

+86 15926207366 

研究负责人电话:

Study leader's telephone:

+86 13971086498 

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:

ranxiao1001@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

shushengli16@sina.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:

湖北省武汉市解放大道1095号同济医院重症医学科 

研究负责人通讯地址:

湖北省武汉市解放大道1095号同济医院重症医学科 

Applicant address:

1095 Jiefang Avenue, Wuhan, Hubei, China 

Study leader's address:

1095 Jiefang Avenue, Wuhan, Hubei, 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:

华中科技大学同济医学院附属同济医院 

Applicant's institution:

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology 

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:

TJ-IRB20200318 

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:

华中科技大学同济医学院附属同济医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-03 

伦理委员会联系人:

杜艾桦 

Contact Name of the ethic committee:

Du Aihua 

伦理委员会联系地址:

湖北省武汉市解放大道1095号同济医院7号楼1003室 

Contact Address of the ethic committee:

Room 1003, Building 7, Tongji Hospital, 1095 Jiefang Avenue, Wuhan, Hubei, 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:

华中科技大学同济医学院附属同济医院 

Primary sponsor:

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology 

研究实施负责(组长)单位地址:

湖北省武汉市解放大道1095号 

Primary sponsor's address:

1095 Jiefang Avenue, Wuhan, Hubei, 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

华中科技大学同济医学院附属同济医院

具体地址:

湖北省武汉市解放大道1095号

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:

1095 Jiefang Ave, Wuhan City, Hubei Province

经费或物资来源:

华中科技大学新型冠状病毒肺炎专项研究 

Source(s) of funding:

Huazhong University of Science and Technology COVID-19 professional project 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19)  

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:

探索性研究/预试验 

Study phase:

研究目的:

本研究将确诊2019-nCoV肺炎收入ICU的危重患者作为研究对象,研究重点通过患者的氧合指数、血管外肺水、肺毛细血管通透性指数、炎症因子水平、TK水平等指标评价患者的ARDS和肺部渗出的严重程度。通过CRRT治疗监测过程中各指标的动态变化情况,从而初步探讨CRRT治疗2019-nCoV肺炎重症患者肺部渗出的疗效以及可能的机制。 

Objectives of Study:

In this study, the critically ill patients who were diagnosed with 2019-nCoV pneumonia in ICU are taken as the research objects. The study focuses on the evaluation of ARDS and the severity of pulmonary exudation by the indexes of oxygenation index, extravascular pulmonary water, pulmonary capillary permeability index, inflammatory factor level, TK level and so on. Through the dynamic changes of each index in the course of CRRT treatment monitoring, the therapeutic effect and possible mechanism of CRRT in 2019-nCoV pneumonia patients with severe pulmonary exudation are preliminarily discussed. 

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:

(1)2019-nCoV咽拭子或其他标本核酸阳性的确诊成人患者; (2)胸部影像学有明确肺部渗出表现; (3)根据2012年柏林标准诊断为ARDS(氧合指数<200mmHg),而需要氧疗或机械通气。 

Inclusion criteria

1. Adult patients confirmed by 2019-nCov throat swab or other samples of nucleic acid positive; 2. Patients with clear manifestations of pulmonary exudation on chest imaging; 3. Patients requiring oxygen therapy or mechanical ventilation, ARDS (oxygenation index < 200mmHg) was diagnosed according to the Berlin standard in 2012. 

排除标准:

(1)处于疾病终末期,已经心肺复苏的患者; (2)孕妇。 

Exclusion criteria:

1. Patients with cardiopulmonary resuscitation at the end of the disease; 2. Pregnant women. 

研究实施时间:

Study execute time:

From2020-03-08To 2020-06-08 

征募观察对象时间:

Recruiting time:

From2020-03-08To 2020-06-01 

干预措施:

Interventions:

组别:

CRRT组

样本量:

76

Group:

CRRT group

Sample size:

干预措施:

连续性肾脏替代治疗

干预措施代码:

Intervention:

CRRT

Intervention code:

组别:

对照组

样本量:

76

Group:

Control group

Sample size:

干预措施:

常规治疗,有紧急指征时才进行CRRT治疗

干预措施代码:

Intervention:

Routine treatment, CRRT only when there are emergency indications

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三级教学型医院 

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

胸部影像学

指标类型:

主要指标 

Outcome:

Chest imaging

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

氧合指数

指标类型:

主要指标 

Outcome:

Oxygenation index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血管外肺水

指标类型:

主要指标 

Outcome:

Extravascular pulmonary water

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺毛细血管通透性指数

指标类型:

主要指标 

Outcome:

pulmonary vascular permeability index, PVPI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症因子

指标类型:

主要指标 

Outcome:

Inflammatory factors

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

组织激肽释放酶

指标类型:

主要指标 

Outcome:

Tissue kallikrein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

机械通气时间(天)

指标类型:

次要指标 

Outcome:

Mechanical ventilation time (days)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总住院时间(天)

指标类型:

次要指标 

Outcome:

Total hospitalization time (days)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

28天全因死亡率

指标类型:

次要指标 

Outcome:

28-day all-cause mortality

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:

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 18 years
最大 Max age 90 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):

研究者将经筛选合格的受试者按就诊先后顺序依次编号,以随机数字表上对应数字的单双数分为激素治疗组和对照组。

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

The researchers number the qualified subjects according to the order of their visits, and divide them into the corticosteroid therapy group and the control group by the odd and even numbers of the corresponding numbers on the random number table.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

Yes

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):

本课题组收集的原始数据将以学术论文的形式共享及发表,预计在2020年7月份。

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

The raw data collected by this research group will be shared and published in the form of academic papers, which is expected to be shared in July 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:

本课题的原始数据以病例记录表的形式收集所需所有数据,并通过电子数据(如表格、图形文件等)将完整数据进行管理及保存。

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

The original data of this subject is collected in the form of a case record form, and all the data is managed and saved through electronic data (such as forms, graphic files, etc.)

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2020-03-06
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