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ICU患者AGI分级标准的适用性及早期 肠内营养应用研究
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注册号:

Registration number:

ChiCTR-OCS-13003824 

最近更新日期:

Date of Last Refreshed on:

2016-05-31 

注册时间:

Date of Registration:

2013-09-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

ICU患者AGI分级标准的适用性及早期 肠内营养应用研究 

Public title:

The availablity of definition for acute gastrointestinal injury with its four grades of severity and the application of early eternal nutrition in critically ill patients 

研究课题的正式科学名称:

ICU患者AGI分级标准的适用性及早期 肠内营养应用研究 

Scientific title:

The availablity of definition for acute gastrointestinal injury with its four grades of severity and the application of early eternal nutrition in critically ill patients 

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:

呼邦传 

研究负责人:

孙仁华 

Applicant:

Hu Bangchuan 

Study leader:

Sun Renhua 

申请注册联系人电话:

Applicant telephone:

+86 13175111296 

研究负责人电话:

Study leader's telephone:

+86 13505710366 

申请注册联系人传真 :

Applicant Fax:

+86 0571 85131448 

研究负责人传真:

Study leader's fax:

+86 0571 85131448 

申请注册联系人电子邮件:

Applicant E-mail:

hubangchuanicu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jqin168@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.hospitalstar.com 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.hospitalstar.com 

申请注册联系人通讯地址:

杭州市上塘路158号 

研究负责人通讯地址:

杭州市上塘路158号 

Applicant address:

158 Shangtang Road, Hangzhou, Zhejiang, China 

Study leader's address:

158 Shangtang Road, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310014 

研究负责人邮政编码:

Study leader's postcode:

310014 

申请人所在单位:

浙江省人民医院ICU 

Applicant's institution:

Zhejiang Provincial People's 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:

2013KY050 

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:

浙江省人民医院伦理委员会 

Name of the ethic committee:

the Ethics Committee of Zhejiang Provincial People' s Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-27 

研究实施负责(组长)单位:

浙江省人民医院 

Primary sponsor:

Zhejiang Provincial People's Hospital 

研究实施负责(组长)单位地址:

杭州市上塘路158号 

Primary sponsor's address:

158 Shangtang Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江省人民医院

具体地址:

杭州市上塘路158号

Institution
hospital:

Zhejiang Provincial People' s Hospital

Address:

158 Shangtang Road, Hangzhou, Zhejiang, China

经费或物资来源:

浙江省医药卫生科技项目 

Source(s) of funding:

The study was financially supported by a grant from Health Bureau of Zhejiang Province 

研究疾病:

急性胃肠损伤 

Target disease:

acute gastrointestinal 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:

其它 

Study phase:

Other 

研究目的:

1.调查ICU危重病患者中AGI的分级情况;2.明确不同AGI分级患者早期肠内营养耐受性和入ICU 7天内热卡蛋白质达标率;3.初步探讨不同AGI分级患者早期肠内营养达标对其免疫功能、机械通气持续时间以及生存预后的影响。 

Objectives of Study:

To investigate the situation of the AGI grades in critically ill patients; To observe the tolerance of early eternal nutrition in the patients with different AGI grades and the proportion of achieve energy target within 7 days after ICU admission; To explore the effect of attaining the energy target during early eternal nutrition on immune function, duration of mechanical ventilation, and the total mortality in the patients with the different AGI grade. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

1.年龄>18岁;2.APACHE II评分>8分;3.ICU入住时间>24h;4.患者或其家属同意参加并签署知情同意书; 

Inclusion criteria

1. Aged more than 18 years; 2. APACHE II score more than 8 score; 3. Duration of ICU stay more than 24 hour; 4. All participants or their relatives gave informed written consent. 

排除标准:

1.频临死亡者;2.筛选期间90天参加过其它临床实验研究;3.存在肠内营养药物过敏;4.恶性肿瘤终末期;5.怀孕或哺乳期; 

Exclusion criteria:

1. Dying patients; 2. The patients have been enrolled in other clinical trials before they were recruited in the current study; 3. the patients have allergied for the eternal nutrition material; 4. maliganince 

研究实施时间:

Study execute time:

From2013-07-01To 2014-01-30 

干预措施:

Interventions:

组别:

连续病例

样本量:

400

Group:

case series

Sample size:

干预措施:

ICU patients

干预措施代码:

Intervention:

ICU patients

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Zhejiang Provincial People' s Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学附属邵逸夫医院 

单位级别:

三级甲等 

Institution
hospital:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Zhejiang Chinese Medicine University  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江中医药大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Zhejiang Chinese Medicine University  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江中医药大学第三附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Third Affiliated Hospital of Zhejiang Chinese Medicine University  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

杭州市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Hangzhou First People' s Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

嘉兴 

Country:

China 

Province:

Zhejiang 

City:

Jiaxing 

单位(医院):

嘉兴市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Jiaxing First People' s Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

杭州市第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Hangzhou Second People' s Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

金华 

Country:

China 

Province:

Zhejiang 

City:

Jinhua 

单位(医院):

金华市中心医院 

单位级别:

三级甲等 

Institution
hospital:

The Central Hospital of Jinhua City  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

台州 

Country:

China 

Province:

Zhejiang 

City:

Taizhou 

单位(医院):

浙江省台州医院 

单位级别:

三级甲等 

Institution
hospital:

Taizhou Hospital of Zhejiang Province  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

宁波 

Country:

China 

Province:

Zhejiang 

City:

Ningbo 

单位(医院):

宁波李惠利医院 

单位级别:

三级甲等 

Institution
hospital:

Ningbo Medical Treatment Center Lihuili Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

湖州 

Country:

China 

Province:

Zhejiang 

City:

Huzhou 

单位(医院):

湖州市中心医院 

单位级别:

三级甲等 

Institution
hospital:

The Central Hospital of Huzhou City  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

丽水 

Country:

China 

Province:

Zhejiang 

City:

Lishui 

单位(医院):

丽水市中心医院 

单位级别:

三级甲等 

Institution
hospital:

The Central Hospital of Lishui City  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

绍兴 

Country:

China 

Province:

Zhejiang 

City:

Shaoxing 

单位(医院):

绍兴市人民医院 

单位级别:

三级甲等 

Institution
hospital:

The Shaoxing People' s Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

诸暨 

Country:

China 

Province:

Zhejiang 

City:

Zhuji 

单位(医院):

诸暨市人民医院 

单位级别:

三级乙等 

Institution
hospital:

The Zhuji People' s Hospital  

Level of the institution:

Class B grade III 

测量指标:

Outcomes:

指标中文名:

腹内压

指标类型:

主要指标 

Outcome:

Intra-abdominal pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

残胃量

指标类型:

主要指标 

Outcome:

Gastric residual volume

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

前白蛋白

指标类型:

主要指标 

Outcome:

Prealbumin

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

SAS程序

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

SAS Procedure

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/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):

浙江人民医院

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

Zhejiang Provincial People s Hospital

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:

浙江人民医院

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

Zhejiang Provincial People s Hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-09-29
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