Today is 2019-12-12

Cross-sectional study of non-hepatic hyperammonemia in ICU of Chineses
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注册号:

Registration number:

ChiCTR1900026632 

最近更新日期:

Date of Last Refreshed on:

2019-10-16 

注册时间:

Date of Registration:

2019-10-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国 ICU 内成人非肝病性高血氨的横断面研究 

Public title:

Cross-sectional study of non-hepatic hyperammonemia in ICU of Chineses 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国 ICU 内成人非肝病性高血氨的横断面研究 

Scientific title:

Cross-sectional study of non-hepatic hyperammonemia in ICU of Chineses 

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:

姚志鹏 

研究负责人:

王洪亮 

Applicant:

Yao Zhipeng 

Study leader:

Wang Hongliang 

申请注册联系人电话:

Applicant telephone:

+86 13895792689 

研究负责人电话:

Study leader's telephone:

+86 15045377888 

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:

yaozhipeng215@163.com 

研究负责人电子邮件:

Study leader's E-mail:

icuwanghongliang@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:

黑龙江省哈尔滨市南岗区学府路 246 号 

研究负责人通讯地址:

黑龙江省哈尔滨市南岗区学府路 246 号 

Applicant address:

246 Xuefu Road, Nangang District, Harbin, Heilongjiang, China 

Study leader's address:

246 Xuefu Road, Nangang District, Harbin, Heilongjiang, 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:

哈尔滨医科大学附属第二医院 

Applicant's institution:

The Second Affiliated Hospital of Harbin Medical 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:

KY2019-184 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

哈尔滨医科大学附属第二医院 

Name of the ethic committee:

The Second Affiliated Hospital of Harbin Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-23 

伦理委员会联系人:

郝天军 

Contact Name of the ethic committee:

Hao Tianjun 

伦理委员会联系地址:

黑龙江省哈尔滨市南岗区学府路 246 号 

Contact Address of the ethic committee:

246 Xuefu Road, Nangang District, Harbin, Heilongjiang, China 

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:

哈尔滨医科大学附属第二医院 

Primary sponsor:

The Second Affiliated Hospital of Harbin Medical University 

研究实施负责(组长)单位地址:

黑龙江省哈尔滨市南岗区学府路 246 号 

Primary sponsor's address:

246 Xuefu Road, Nangang District, Harbin, Heilongjiang, 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):

黑龙江

市(区县):

Country:

China

Province:

Heilongjiang

City:

单位(医院):

哈尔滨医科大学附属第二医院

具体地址:

黑龙江省哈尔滨市南岗区学府路 246 号

Institution
hospital:

The Second Affiliated Hospital of Harbin Medical

Address:

246 Xuefu Road, Nangang District, Harbin, Heilongjiang, China

经费或物资来源:

自筹 

Source(s) of funding:

raise independently 

研究疾病:

非肝病性高血氨 

Target disease:

non-hepatic hyperammonemia 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

中国ICU内成人非肝病性高血氨的发生率以及临床特点 

Objectives of Study:

ncidence and clinical characteristics of non-hepatic hyperammonemia in ICU of Chinese  

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) 研究期间转入和直接入住ICU的患者; (2) 年龄≥18周岁; (3) 调查期间符合入选标准的全部患者。 

Inclusion criteria

(1) patients transferred to and directly admitted to ICU during the study period; (2) Aged >=18 years old; (3) all patients meeting the inclusion criteria during the survey period. 

排除标准:

(1)急性肝衰竭; (2)慢性肝病; (3)再次入住ICU; (4)未签署知情同意的患者。 

Exclusion criteria:

(1) acute liver failure; (2) chronic liver disease; (3) re-admission to ICU; (4) patients without informed consent. 

研究实施时间:

Study execute time:

From2019-11-01To 2020-06-30 

干预措施:

Interventions:

组别:

不分组

样本量:

1330

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):

黑龙江 

市(区县):

牡丹江 

Country:

China 

Province:

Heilongjiang 

City:

Mudanjiang 

单位(医院):

牡丹江医学院红旗医院 

单位级别:

三级甲等 

Institution
hospital:

Mudanjiang Medical College Hongqi Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

佳木斯 

Country:

China 

Province:

Heilongjiang 

City:

Jiamusi 

单位(医院):

佳木斯大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Hospital Affiliated to Jiamusi University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

大庆 

Country:

China 

Province:

Heilongjiang 

City:

Daqing 

单位(医院):

大庆油田总医院 

单位级别:

三级甲等 

Institution
hospital:

Daqing Oilfield General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

哈尔滨医科大学附属第四医院 

单位级别:

三级甲等 

Institution
hospital:

The Fourth Affiliated Hospital of Harbin Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

佳木斯 

Country:

China 

Province:

Heilongjiang 

City:

Jiamusi 

单位(医院):

佳木斯中心医院 

单位级别:

三级甲等 

Institution
hospital:

Jiamusi Central Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

黑龙江省医院南岗分院 

单位级别:

三级甲等 

Institution
hospital:

Heilongjiang Provincial Hospital Nangang Branch  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

黑龙江省农垦医院 

单位级别:

三级甲等 

Institution
hospital:

Heilongjiang Provincial Agricultural Reclamation Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

大庆 

Country:

China 

Province:

Heilongjiang 

City:

Daqing 

单位(医院):

大庆龙南医院 

单位级别:

三级甲等 

Institution
hospital:

Daqing Longnan Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

牡丹江 

Country:

China 

Province:

Heilongjiang 

City:

Mudanjiang 

单位(医院):

牡丹江市第二医院 

单位级别:

三级甲等 

Institution
hospital:

Mudanjiang Second Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

哈尔滨市第一医院 

单位级别:

三级甲等 

Institution
hospital:

Harbin First Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

大庆 

Country:

China 

Province:

Heilongjiang 

City:

Daqing 

单位(医院):

大庆人民医院 

单位级别:

三级甲等 

Institution
hospital:

Daqing People's Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血氨

指标类型:

主要指标 

Outcome:

blood ammonia

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乳酸

指标类型:

主要指标 

Outcome:

lactate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

blood glucose

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酐

指标类型:

次要指标 

Outcome:

creatinine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿素

指标类型:

次要指标 

Outcome:

BUN

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白蛋白

指标类型:

次要指标 

Outcome:

albumin

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:

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:

正在进行

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):

不需要随机分组

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

Random grouping is not required

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:

Within six months after the trial complete

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):

纸质病例报告表格

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

CRF

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:

入选患者的唯一编码应记录在病例报告表上,并与入选患者 入组表上该入选患者姓名的号码相互一致;为保护入选患者的隐私,入选患者的全名不应出现在病例报告表或其他任何须向申办者提供的试验文件上;填写病例报告表时应及时、字迹清楚、内容完整;而且病例报告表一般不应涂改,如果有错误修改,应将元记录用横线划掉,并在修改处签名、签日期。通常应该首先将尽可能详细的入选患者记录在原始病例中,再对照原始数据填写病例报告表。为保证试验资料的真实准确,检查员将原始数据进行核对。填写病例报告表的人员应在完成病例报告表上签字并注明日期以确认所填写的资料完整、真实、 准确。 如必要, 主要研究者加签并注明日期以保证数据的质量。完成的病例报告表由临床质控员审查后,进行数据录入。一旦数据库锁定,病例报告表的内容不得再做修改。研究者应当使资料保存完整,按照我国GCP 原则,对研究资 料应保存5 年以上。

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

The unique encoding of the enrolled patients should be recorded on the case report form and included with the enrolled patients; On the table into the group of patients' name numbers consistent with each other; for the protection of patients privacy, the patient's name should not appear in the case report form or any other applicant shall provide to the test file; fill in the case report form should be timely, legible, complete content and is generally not the case report form; if there is an error should be altered, modified, should be recorded by the line element and sign off, in the modification of signature and date. Patients should be included in the original case as far as possible in detail, and then fill in the case report form with the original data. In order to ensure the authenticity and accuracy of the test data, the inspectors checked the original data. The person who filled out the case report should sign on the completed case report and indicate the date to confirm that the information is complete, true and accurate. If necessary, the principal will sign and mark the date to ensure the quality of the data. The case report form was checked by the clinical quality control staff, and then the data was input. Once the database is locked, the contents of the case report form should not be modified. The researcher should keep the data intact, according to the GCP principle of China The material should be stored for more than 5 years.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-10-16
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