ChiCTR2100046077 版本V1.0 版本创建时间2021/12/14 01:03:27 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100046077 

最近更新日期：

Date of Last Refreshed on：

 2021-05-04 02:56:29 

注册时间：

Date of Registration：

 2021-05-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

USING MACHINE LEARNING TO PREDICT KIDNEY INJURY AFTER LOWER LIMB ANGIOPLASTY

Public title：

USING MACHINE LEARNING TO PREDICT KIDNEY INJURY AFTER LOWER LIMB ANGIOPLASTY

注册题目简写：

English Acronym：

研究课题的正式科学名称：

MACHINE LEARNING PREDICTS CONTRAST INDUCED ACUTE KIDNEY INJURY IN ELECTIVE LOWER LIMB PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY: A RETROSPECTIVE COHORT

Scientific title：

MACHINE LEARNING PREDICTS CONTRAST INDUCED ACUTE KIDNEY INJURY IN ELECTIVE LOWER LIMB PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY: A RETROSPECTIVE COHORT

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：

Daniel Lim 

研究负责人：

Hairil Rizal Abdullah 

Applicant：

Daniel Lim 

Study leader：

Hairil Rizal Abdullah 

申请注册联系人电话：

Applicant telephone：

 +65 97307915

研究负责人电话：

Study leader's
telephone：

+65 6222 3322

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：

 limyzd@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 hairil.rizal.abdullah@singhealth.com.sg

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：

Outram Road, Singapore

研究负责人通讯地址：

Outram Road, Singapore

Applicant address：

Outram Road, Singapore

Study leader's address：

Outram Road, Singapore

申请注册联系人邮政编码：

Applicant postcode：

 169608

研究负责人邮政编码：

Study leader's postcode：

 169608

申请人所在单位：

新加坡总医院

Applicant's institution：

Singapore General Hospital

研究负责人所在单位：

新加坡总医院

Affiliation of the Leader：

Singapore General Hospital

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：

 2020/2659

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：

SingHealth Centralised Institutional Review Board

Name of the ethic committee：

SingHealth Centralised Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 00:00:00

伦理委员会联系人：

SingHealth Centralised Institutional Review Board

Contact Name of the ethic committee：

SingHealth Centralised Institutional Review Board

伦理委员会联系地址：

Singapore General Hospital, Singapore 169608

Contact Address of the ethic committee：

Singapore General Hospital, Singapore 169608

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：

Singapore General Hospital

Primary sponsor：

Singapore General Hospital

研究实施负责（组长）单位地址：

Outram Road, Singapore 169608

Primary sponsor's address：

Outram Road, Singapore 169608

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

No funding

Source(s) of funding：

No funding

研究疾病：

Contrast Associated Acute Kidney Injury  

Target disease：

Contrast Associated Acute Kidney 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：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

Examine risk factors for contrast associated acute kidney injury after elective lower limb percutaneous transluminal angioplasty. Develop machine learning models for risk prediction.  

Objectives of Study：

Examine risk factors for contrast associated acute kidney injury after elective lower limb percutaneous transluminal angioplasty. Develop machine learning models for risk prediction.

药物成份或治疗方案详述：

This was a single-center retrospective cohort study, conducted in a large tertiary academic medical center in Singapore. The study was granted an exemption by the local Institutional Review Board, with waiver of patient consent due to the use of anonymised routinely collected clinical data. Our study did not involve patients in the study design or outcome selection. The recruitment period from was from 2014 to 2020. 

Description for medicine or protocol of treatment in detail：

This was a single-center retrospective cohort study, conducted in a large tertiary academic medical center in Singapore. The study was granted an exemption by the local Institutional Review Board, with waiver of patient consent due to the use of anonymised routinely collected clinical data. Our study did not involve patients in the study design or outcome selection. The recruitment period from was from 2014 to 2020. 

纳入标准：

- All cases of lower limb PTA as a single procedure identified via surgical codes;
- Performed at Singapore General Hospital;
- Recruitment period from 2014 to 2020.

Inclusion criteria

- All cases of lower limb PTA as a single procedure identified via surgical codes;
- Performed at Singapore General Hospital;
- Recruitment period from 2014 to 2020.

排除标准：

- Patients <21 years old;
- Patients with a preoperative estimated Glomerular Filtration Rate (eGFR) of <15mL/min/1.73 m2 as defined by the Modification of Diet in Renal Disease (MDRD);
- Patients with no valid preoperative or postoperative SCr.

Exclusion criteria：

- Patients <21 years old;
- Patients with a preoperative estimated Glomerular Filtration Rate (eGFR) of <15mL/min/1.73 m2 as defined by the Modification of Diet in Renal Disease (MDRD);
- Patients with no valid preoperative or postoperative SCr.

研究实施时间：

Study execute time：

从 From 2020-07-01 00:00:00至 To 2021-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-01-01 00:00:00 至 To 2020-01-01 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 610

Group：

Case series

Sample size：

干预措施：

N/A

干预措施代码：

Intervention：

Not applicable

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 新加坡

省(直辖市)：

 新加坡 

市(区县)：

  

Country：

Singapore

Province：

Singapore

City：

单位(医院)：

 Singapore General Hospital 

单位级别：

  

Institution
hospital：

Singapore General Hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Contrast associated acute kidney injury

指标类型：

主要指标

Outcome：

Contrast associated acute kidney injury

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：

Not applicable

组织：

Sample Name：

Not applicable

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 21 岁 years
最大 Max age 99 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）：

Not applicable as this is a retrospective cohort

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

Not applicable as this is a retrospective cohort

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：

Not applicable as this is a retrospective cohort

Blinding：

Not applicable as this is a retrospective cohort

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 possible at this time, will need separate institutional approval for any data sharing

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

Not possible at this time, will need separate institutional approval for any data sharing

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：

Oracle Business Intelligence Enterprise Edition

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

Oracle Business Intelligence Enterprise Edition

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-05-04 02:56:29