急诊72小时非计划再就诊高风险患者临床预测模型的开发与验证:一项单中心回顾性队列研究

注册号:

Registration number:

ChiCTR2600125896 

最近更新日期:

Date of Last Refreshed on:

2026-06-01 16:12:56 

注册时间:

Date of Registration:

2026-06-01 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

急诊72小时非计划再就诊高风险患者临床预测模型的开发与验证:一项单中心回顾性队列研究

Public title:

Development and Validation of a Clinical Prediction Model for High-Risk 72-Hour Unplanned Emergency Department Revisits: A Retrospective Single-Center Study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

急诊72小时非计划再就诊高风险患者临床预测模型的开发与验证:一项单中心回顾性队列研究

Scientific title:

Development and Validation of a Clinical Prediction Model for High-Risk 72-Hour Unplanned Emergency Department Revisits: A Retrospective Single-Center 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:

申请注册联系人:

刘辉 

研究负责人:

刘辉 

Applicant:

Liu Hui 

Study leader:

Liu Hui 

申请注册联系人电话:

Applicant telephone:

+86 183 0833 0539

研究负责人电话:

Study leader's
telephone:

+86 830 3165120

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:

1353575360@qq.com

研究负责人电子邮件:

Study leader's E-mail:

1353575360@qq.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:

四川省泸州市江阳区太平街25号

研究负责人通讯地址:

四川省泸州市江阳区太平街25号

Applicant address:

No.25 Taiping Street, Luzhou City, Sichuan Province

Study leader's address:

No.25 Taiping Street, Luzhou City, Sichuan 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:

西南医科大学附属医院

Applicant's institution:

The Affiliated Hospital of Southwest Medical University

研究负责人所在单位:

西南医科大学附属医院

Affiliation of the Leader:

The affiliated hospital of southwest medical university

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

KY2026341

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:

西南医科大学附属医院临床试验伦理委员会

Name of the ethic committee:

The Clinical Research Ethics Committee Affiliated Hospital of Southwest Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2026-05-23 00:00:00

伦理委员会联系人:

张增瑞

Contact Name of the ethic committee:

Zhang Zengrui

伦理委员会联系地址:

四川省泸州市江阳区太平街25号

Contact Address of the ethic committee:

No.25 Taiping Street, Luzhou City, Sichuan Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 830 3165273

伦理委员会联系人邮箱:

Contact email of the ethic committee:

274692738@qq.com

研究实施负责(组长)单位:

西南医科大学附属医院

Primary sponsor:

The affiliated hospital of southwest medical university

研究实施负责(组长)单位地址:

四川省泸州市江阳区太平街25号

Primary sponsor's address:

No.25 Taiping Street, Luzhou City, Sichuan 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):

四川省

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

西南医科大学附属医院

具体地址:

四川省泸州市江阳区太平街25号

Institution
hospital:

The affiliated hospital of southwest medical university

Address:

No.25 Taiping Street, Luzhou City, Sichuan Province

经费或物资来源:

自选课题(自筹)

Source(s) of funding:

Optional Research Project (Self-Financed)

研究疾病:

无  

Target disease:

N/A

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:

其它 

Study phase:

N/A

研究设计:

连续入组 

Study design:

Sequential 

研究目的:

主要目的: (1)开发一个基于常规急诊就诊数据的72小时高风险再就诊临床预测模型。 (2)通过时序验证方法评估模型的区分度和校准度。 次要目的: (1)比较传统Logistic回归与机器学习方法的预测效能。 (2)构建可视化列线图,并开发在线风险计算器供临床使用。 (3)识别与高风险再就诊相关的独立预测因素。  

Objectives of Study:

Primary Objectives:(1) To develop a 72-hour high-risk revisit clinical prediction model based on conventional emergency department visit data.(2) To evaluate the discrimination and calibration of the model using temporal validation methods.Secondary Objectives:(1) To compare the predictive performance of traditional Logistic regression and machine learning methods.(2) To construct a visualized nomogram and develop an online risk calculator for clinical application.(3) To identify independent predictive factors associated with high-risk revisit.

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.就诊后直接收入院、转入ICU或死亡的患者;
2.计划性复诊(如术后随访、门诊预约复查);
3.以精神疾病为主诉的就诊(诊断编码ICD-10为F00-F99);
4.关键预测变量缺失率>40%的病例;
5.无法追溯72小时后续就诊情况的病例;

Exclusion criteria:

1.Patients who are directly admitted to hospital, transferred to ICU or die after medical consultation;
2.Scheduled follow-up visits (such as postoperative follow-ups and scheduled outpatient re-examinations);
3.Medical visits mainly due to mental illnesses (ICD-10 diagnostic codes: F00-F99);
4.Cases with a missing rate of key predictive variables exceeding 40%;
5.Cases with untraceable follow-up medical visits within 72 hours;

研究实施时间:

Study execute time:

From 2026-06-01 00:00:00 To 2027-06-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-06-01 00:00:00 To 2027-06-30 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

5000

Group:

Observation group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

四川省 

市(区县):

 

Country:

China

Province:

Sichuan

City:

单位(医院):

西南医科大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

The affiliated hospital of southwest medical university

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

非计划再就诊且需住院

指标类型:

主要指标

Outcome:

Type:

Primary indicator

测量时间点:

72 小时内

测量方法:

抽血

Measure time point of outcome:

Measure method:

blood drawing

指标中文名:

转入 ICU 或死亡

指标类型:

主要指标

Outcome:

Type:

Primary indicator

测量时间点:

72 小时内

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

非计划再就诊后再次离院

指标类型:

次要指标

Outcome:

Type:

Secondary indicator

测量时间点:

72 小时内

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:

N/A

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

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 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):

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

Blinding:

None

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):

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

N/A

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:

HIS系统导出数据

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

Export data from HIS system

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2026-06-01 16:12:56