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Pre-operative N-terminal pro-B-type natriuretic peptide and its effect on predicting the risk of acute kidney injury after non-cardiac surgery
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注册号:

Registration number:

ChiCTR2200055942 

最近更新日期:

Date of Last Refreshed on:

2022-01-28 

注册时间:

Date of Registration:

2022-01-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

患者术前血清NT-proBNP水平对现有术后急性肾功能损伤预测模型的改善效果的研究 

Public title:

Pre-operative N-terminal pro-B-type natriuretic peptide and its effect on predicting the risk of acute kidney injury after non-cardiac surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

患者术前血清NT-proBNP水平对现有术后急性肾功能损伤预测模型的改善效果的研究 

Scientific title:

Pre-operative N-terminal pro-B-type natriuretic peptide and its effect on predicting the risk of acute kidney injury after non-cardiac surgery 

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:

唐永忠 

研究负责人:

欧阳文 

Applicant:

Tang Yongzhong 

Study leader:

OuYangwen 

申请注册联系人电话:

Applicant telephone:

+86 13467542241 

研究负责人电话:

Study leader's telephone:

13974934441 

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:

tangyongzhong@csu.edu 

研究负责人电子邮件:

Study leader's E-mail:

yangwenou@126.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:

湖南长沙岳麓桐梓坡路138号 

研究负责人通讯地址:

湖南长沙岳麓桐梓坡路138号 

Applicant address:

Changsha,No.138 Road Tongzipo District Yuelv  

Study leader's address:

Changsha,No.138 Road Tongzipo District Yuelv  

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:

中南大学湘雅三医院 

Applicant's institution:

The Third Xiangya 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:

快22002 

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:

中南大学湘雅三医院伦理委员会 

Name of the ethic committee:

IRB of The Third Xiangya Hospital of Central South University  

伦理委员会批准日期:

Date of approved by ethic committee:

2022-01-04 

伦理委员会联系人:

何庆南 

Contact Name of the ethic committee:

He Qingnan 

伦理委员会联系地址:

湖南长沙岳麓区桐梓坡路138号 

Contact Address of the ethic committee:

No.138 Road Tongzipo District Yuelv,Changsha 

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:

中南大学湘雅三医院 

Primary sponsor:

The Third Xiangya hospital of Central South University  

研究实施负责(组长)单位地址:

湖南长沙岳麓区桐梓坡路138号 

Primary sponsor's address:

Changsha,No.138 Road Tongzipo District Yuelv  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖南

市(区县):

Country:

China

Province:

Hunan

City:

单位(医院):

中南大学湘雅三医院

具体地址:

湖南长沙岳麓区桐梓坡路138号

Institution
hospital:

The Third Xiangya Hospital of Central South University

Address:

No. 138 Road Tongzipo District Yuelv

经费或物资来源:

自筹 

Source(s) of funding:

Self-raising 

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:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

在本研究通过收集非心脏手术患者的临床资料与血液样本,探索术前血清 NT-proBNP 水平是否能帮助预测患者的术后 AKI的发生风险。  

Objectives of Study:

In this study, clinical data and the level of serum NT-proBNP of patients undergoing non-cardiac surgery were collected to explore whether the level of serum NT-proBNP can be used to predict the risk of post operative acute kidney injury.  

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:

患者于 2012 年 10 月 1 日至 2019 年 10 月 1 日期间在我院接受非心脏手术,在术前 30 天内和术后 7 天内有进行血清肌酐以及 NT-proBNP 水平进行测量和收集 

Inclusion criteria

adult patients (≥18years) undergoing non-cardiac surgery performed between 1 October 2012 to 1 October 2019. Levels of serum NT-proBNP and creatinine were collected during their hospital stay.  

排除标准:

(1)患者年龄<18 岁(2)患者术前 ASA 分级为 VI 级(3)患者接受的是由外科医生施行的局部麻醉手术(4)患者接受下述种类的外科手术:器官移植手术、心脏手术、血管手术、泌尿外科手术(包含肾移植手术)、产科手术(5)患者血清肌酐或相关数据缺乏(6)患者术前发生急性心肌梗死(7)患者术前肾小球滤过率(eGFR) <15 ml min-11.73 m-2或存在蛋白尿(8)患者数据严重缺失,无法进行分析 

Exclusion criteria:

The exclusion criteria were ASA grade VI, surgeon-administrated regional anaesthesia, organ transplant, cardiac, urological (including kidney transplantation), obstetrical surgery, lack of serum creatinine or covariate data , preoperative acute myocardial infarction, glomerular filtration rate (eGFR) <15 ml min-1 1.73 m-2 and proteinuria.  

研究实施时间:

Study execute time:

From2022-02-01To 2022-10-30 

征募观察对象时间:

Recruiting time:

From2022-02-01To 2022-10-30 

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 outcome

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):

血清 NT-proBNP

Index test:

Serum NT-proBNP

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)

接受非心脏手术的患者

例数:

Sample size:

4742

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):

Adults patients undergoing non-cardiac surgery

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):

湖南 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

中南大学湘雅三医院 

单位级别:

三级甲等 

Institution
hospital:

The Third Xiangya Hospital of Central South University  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

血清肌酐

指标类型:

主要指标 

Outcome:

Serum Creatine

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:

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):

NA

盲法:

Blinding:

是否共享原始数据:

IPD sharing

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):

NA

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:

病例记录表

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

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-01-28
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