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感染和膿毒症基因組廣泛表達：先導研究
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注册号：

Registration number：

 ChiCTR1800018535 

最近更新日期：

Date of Last Refreshed on：

 2018-09-22 23:31:29 

注册时间：

Date of Registration：

 2018-09-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

感染和膿毒症基因組廣泛表達：先導研究

Public title：

Genome wide expression in infection and sepsis: a pilot propsective cohort study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

感染和膿毒症基因組廣泛表達：先導研究

Scientific title：

Genome wide expression in infection and sepsis: a pilot propsective cohort study

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：

CUHK_CCRB00623

申请注册联系人：

Lowell Ling 

研究负责人：

Lowell Ling 

Applicant：

Lowell Ling 

Study leader：

Lowell Ling 

申请注册联系人电话：

Applicant telephone：

 +852 3505 2735

研究负责人电话：

Study leader's
telephone：

+852 3505 2735

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：

 lowell.ling@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 lowell.ling@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/592

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/592

申请注册联系人通讯地址：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, New Territories, Hong Kong, China

研究负责人通讯地址：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, New Territories, Hong Kong, China

Applicant address：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, New Territories, Hong Kong, China

Study leader's address：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, New Territories, Hong Kong, 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：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Applicant's institution：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

研究负责人所在单位：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Affiliation of the Leader：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

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：

 2018.287

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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-07-21 00:00:00

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：

香港中文大學

Primary sponsor：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

Primary sponsor's address：

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

感染和膿毒症  

Target disease：

infection and sepsis

研究疾病代码：

Target disease code：

研究类型：

病因学/相关因素研究

Study type：

Cause/Relative factors study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

Feasibility of a genome wide expression study on patients with pneumonia with respect to recruitment, data collection and gene expression analysis  

Objectives of Study：

Feasibility of a genome wide expression study on patients with pneumonia with respect to recruitment, data collection and gene expression analysis

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. immunosupression;
2. current malignancy;
3. chest symptoms not solely accounted by pneumonia (cardiac failure, non-cardiogenic pulmonary oedema, suspected pulmonary embolism, suspected secondary acute respiratory distress syndrome);
4. prisoner/cognitive impairment/age less than 18 years;
5. hospitalization within 1 month;
6. whole blood transfusion within 1 month;
7. blood samples for gene expression could not be taken within 24 hours of admission.

Exclusion criteria：

1. immunosupression;
2. current malignancy;
3. chest symptoms not solely accounted by pneumonia (cardiac failure, non-cardiogenic pulmonary oedema, suspected pulmonary embolism, suspected secondary acute respiratory distress syndrome);
4. prisoner/cognitive impairment/age less than 18 years;
5. hospitalization within 1 month;
6. whole blood transfusion within 1 month;
7. blood samples for gene expression could not be taken within 24 hours of admission.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-10-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 10

Group：

Case series

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 The Chinese University of Hong Kong 

单位级别：

 大學 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

feasibility of a genome wide expression study on patients with pneumonia

指标类型：

主要指标

Outcome：

feasibility of a genome wide expression study on patients with pneumonia

Type：

Primary indicator

测量时间点：

admission to hospital

测量方法：

recruitment rate, gene expression analysis

Measure time point of outcome：

admission to hospital

Measure method：

recruitment rate, gene expression analysis

指标中文名：

peripheral blood mononuclear cell genome wide expression differences uncomplicated pneumonia versus pneumonia with associated sepsis

指标类型：

次要指标

Outcome：

peripheral blood mononuclear cell genome wide expression differences uncomplicated pneumonia versus pneumonia with associated sepsis

Type：

Secondary indicator

测量时间点：

admission to hospital

测量方法：

association of gene expression pattern and frequency of disease

Measure time point of outcome：

admission to hospital

Measure method：

association of gene expression pattern and frequency of disease

指标中文名：

peripheral blood mononuclear cell genome wide expression and association with organ dysfunction

指标类型：

次要指标

Outcome：

peripheral blood mononuclear cell genome wide expression and association with organ dysfunction

Type：

Secondary indicator

测量时间点：

admission to hospital

测量方法：

association of gene expression pattern and sequential organ failure assessment score

Measure time point of outcome：

admission to hospital

Measure method：

association of gene expression pattern and sequential organ failure assessment score

指标中文名：

peripheral blood mononuclear cell genome wide expression and association with clnical outcomes

指标类型：

次要指标

Outcome：

peripheral blood mononuclear cell genome wide expression and association with clnical outcomes

Type：

Secondary indicator

测量时间点：

admission to hospital

测量方法：

association of gene expression pattern and clinical outcomes such as mortality, hospital length of stay

Measure time point of outcome：

admission to hospital

Measure method：

association of gene expression pattern and clinical outcomes such as mortality, hospital length of stay

采集人体标本：

Collecting sample(s)
from participants：

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 岁 years
最大 Max age 岁 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）：

N/A

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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)：

是否共享原始数据：

IPD sharing

否No

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2018-09-22 23:31:29
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