Today is 2020-07-15

Prediction of Acute Kidney Injury After Major Non-Cardiac Surgery with Preoperative Biomarkers: A Case Records Based Retrospective Cohort Study
download

注册号:

Registration number:

ChiCTR1900024056 

最近更新日期:

Date of Last Refreshed on:

2019-07-18 

注册时间:

Date of Registration:

2019-06-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

术前生物标志物预测非心脏手术后急性肾损伤:基于病历记录的研究 

Public title:

Prediction of Acute Kidney Injury After Major Non-Cardiac Surgery with Preoperative Biomarkers: A Case Records Based Retrospective Cohort Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

术前生物标志物预测非心脏手术后急性肾损伤:一项基于病历记录的回顾性队列研究 

Scientific title:

Prediction of Acute Kidney Injury After Major Non-Cardiac Surgery with Preoperative Biomarkers: A Case Records Based Retrospective 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:

 

申请注册联系人:

赵秉诚 

研究负责人:

刘克玄 

Applicant:

Bingcheng Zhao 

Study leader:

Kexuan Liu 

申请注册联系人电话:

Applicant telephone:

+86 13763313653 

研究负责人电话:

Study leader's telephone:

+86 13710684096 

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:

zhaobch@mail2.sysu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

liukexuan507@163.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:

中国广州市广州大道北1838号 

研究负责人通讯地址:

中国广州市广州大道北1838号 

Applicant address:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, China 

Study leader's address:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, 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:

南方医科大学南方医院 

Applicant's institution:

Southern Medical University Nanfang 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:

NFEC-2019-081 

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:

南方医科大学南方医院医学伦理委员会 

Name of the ethic committee:

Medical Ethic Committee of Southern Medical University Nanfang Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-08 

伦理委员会联系人:

张训 

Contact Name of the ethic committee:

Xun Zhang 

伦理委员会联系地址:

中国广州市广州大道北1838号 

Contact Address of the ethic committee:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 020 62787238 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

nfyyec@163.com 

研究实施负责(组长)单位:

南方医科大学南方医院 

Primary sponsor:

Southern Medical University Nanfang Hospital 

研究实施负责(组长)单位地址:

中国广州市广州大道北1838号 

Primary sponsor's address:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医科大学南方医院

具体地址:

中国广州市广州大道北1838号

Institution
hospital:

Southern Medical University Nanfang Hospital

Address:

1838 Guangzhou Avenue North, Baiyun District, Guangzhou, Guangdong, China

经费或物资来源:

研究者发起的非资助项目 

Source(s) of funding:

Investigator initiated study with no funding 

研究疾病:

急性肾损伤 

Target disease:

Acute kidney injury 

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:

其它 

Study phase:

N/A 

研究目的:

非心脏手术后急性肾损伤(AKI)与患者术后近期与远期并发症发生率和死亡率相关。准确的术前AKI风险预测对改善患者结局具有重要意义。目前临床使用的术前AKI预测模型的预测能力有限,可能是由于这些模型主要依赖病史和用药史,较少使用除肾小球滤过率之外的客观生物标志物。本研究的目的是评估术前常规检查中测量的生物标志物是否与术后AKI相关,能否改善临床预测模型的预测能力。 

Objectives of Study:

Postoperative acute kidney injury (AKI) is associated with short- and long-term morbidity and mortality for patients undergoing non-cardiac surgery. Accurate preoperative AKI risk prediction is important for improving outcomes for these patients. The predictive abilities of current AKI risk models are limited, probably because these models rely heavily on comorbidity and medicine history but seldom use biomarkers besides estimated glomerular filtration rate. The objective of this study is to evaluate the association between biomarkers measured in routine preoperative assessment and AKI after non-cardiac surgery, and to examine whether these biomarkers can improve the predictive ability of clinical risk models. 

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:

2008-2018年间在南方医科大学南方医院行全麻或区域麻醉下手术的成年(大于等于18周岁)患者。 

Inclusion criteria

Adult (age >=18 years) patients who underwent surgery under general or regional anesthesia at Southern Medical University Nanfang Hospital from 2008 to 2018. 

排除标准:

1.无术前相关血液检查 2.心脏、移植、泌尿、产科手术 3.小型手术(手术时间小于1h) 4.术前急性肾损伤、术前终末期肾病或曾行肾移植术 5.缺乏术前或术后血清肌酐测量值 

Exclusion criteria:

(1) No preoperative blood test; (2) Cardiac, transplant, urologic, or obstetric surgery; (3) Minor surgery with surgery duration < 1 hour; (4) Evidence of preoperative AKI, preoperative end-stage renal disease or prior kidney transplantation; (5) No preoperative or postoperative creatinine measurements. 

研究实施时间:

Study execute time:

From2019-07-01To 2022-04-30 

干预措施:

Interventions:

组别:

回顾性队列

样本量:

150000

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医科大学南方医院 

单位级别:

三级甲等 

Institution
hospital:

Southern Medical University Nanfang Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

急性肾损伤

指标类型:

主要指标 

Outcome:

acute kidney injury

Type:

Primary indicator 

测量时间点:

术后1-7天

测量方法:

KDIGO 定义

Measure time point of outcome:

postoperative days 1-7

Measure method:

KDIGO definition

指标中文名:

严重急性肾损伤

指标类型:

次要指标 

Outcome:

severe AKI

Type:

Secondary indicator 

测量时间点:

术后1-7天

测量方法:

KDIGO 2-3 期

Measure time point of outcome:

postoperative days 1-7

Measure method:

KDIGO stages 2-3

指标中文名:

术后住院时间

指标类型:

次要指标 

Outcome:

Postoperative length of stay

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:

组织:

Sample Name:

NA

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 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):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

通过合理申请后向申请人公开

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

Data will be available upon reasonable request

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:

电子采集和管理系统

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

Electronic Data Capture system

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-23
return list