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Prognostic factors and diagnostic indicators of liver diseases
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注册号:

Registration number:

ChiCTR2200060123 

最近更新日期:

Date of Last Refreshed on:

2022-05-19 

注册时间:

Date of Registration:

2022-05-19 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

肝脏疾病的预后影响因素和诊断指标 

Public title:

Prognostic factors and diagnostic indicators of liver diseases 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肝病人群中预后和诊断影响因素的队列研究 

Scientific title:

A cohort study of prognostic and diagnostic factors in a population with liver disease 

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:

盛鑫宇 

研究负责人:

曹红翠 

Applicant:

xinyu sheng 

Study leader:

Hongcui Cao 

申请注册联系人电话:

Applicant telephone:

18868126985 

研究负责人电话:

Study leader's telephone:

13858034217 

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:

xysheng12138@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hccao@zju.edu.cn 

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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

No. 79 Qingchun Road, Hangzhou City, Zhejiang Province 

Study leader's address:

No. 79 Qingchun Road, Hangzhou City, Zhejiang Province 

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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Zhejiang 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:

2019-1449-1 

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:

浙江大学医学院附属第一医院科研伦理委员会 

Name of the ethic committee:

Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-05 

伦理委员会联系人:

郑敏 

Contact Name of the ethic committee:

Min Zheng 

伦理委员会联系地址:

浙江省杭州市庆春路79号 

Contact Address of the ethic committee:

No. 79 Qingchun Road, Hangzhou City, Zhejiang Province 

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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

No. 79 Qingchun Road, Hangzhou City, Zhejiang Province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

浙江省杭州市庆春路79号

Institution
hospital:

The First Affiliated Hospital of Zhejiang University

Address:

No. 79 Qingchun Road, Hangzhou City, Zhejiang Province

经费或物资来源:

自筹 

Source(s) of funding:

self-funded 

研究疾病:

肝病 

Target disease:

liver diseases 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

通过队列研究构建新的预后模型,以预测HRS的死亡率。 

Objectives of Study:

Construction of a new prognostic model from a cohort study to predict mortality in HRS. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1.肝肾综合征(HRS)患者的筛选 (1)患者人群:2011年1月-2019年10月,在浙江大学附属第一医院就诊的住院患者。 (2)纳入标准:a.失代偿性肝硬化。 b.急性肾损伤。诊断依据为KDIGO标准。 

Inclusion criteria

1. Screening of patients with hepatorenal syndrome (HRS) (1) Patient population: from January 2011 to October 2019, inpatients who were treated at the First Affiliated Hospital of Zhejiang University. (2) Inclusion criteria: a. Decompensated liver cirrhosis. b. Acute kidney injury. Diagnosis is based on KDIGO criteria. 

排除标准:

排除标准:a.无腹水。b.肝细胞癌及其他种类癌症。c.慢性肾脏疾病。d.既往经过肝脏移植。e.年龄小于18周岁。f.甲状腺疾病。g.严重免疫缺陷。h.住院时间少于1周。i.病历信息不全。 

Exclusion criteria:

Exclusion criteria: a. No ascites. b. Hepatocellular carcinoma and other types of cancer. c. Chronic kidney disease. d. Previous liver transplantation. e. The age is less than 18 years old. f. Thyroid disease. g. Severe immunodeficiency. h. The hospital stay is less than 1 week. i. Incomplete medical record information. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-03-31 

征募观察对象时间:

Recruiting time:

From2019-01-01To 2021-03-31 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcomes

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

预后模型

Index test:

Prognostic model

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

肝肾综合征患者

例数:

Sample size:

669

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients with hepatorenal syndrome

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Zhejiang University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

28天病死率

指标类型:

主要指标 

Outcome:

mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SEN, SPE, ACC, ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, ROC

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:

结束

Completed

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):

全部肝病人群

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

All patients with liver diseases

盲法:

Blinding:

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):

http://www.medresman.org/

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

http://www.medresman.org/

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:

ResMan

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

ResMan

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-05-19
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