中国患者住院期间营养状态变化的多中心动态调查

注册号:

Registration number:

ChiCTR-EPC-14005253 

最近更新日期:

Date of Last Refreshed on:

2014-10-25 12:47:05 

注册时间:

Date of Registration:

2014-09-09 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

中国患者住院期间营养状态变化的多中心动态调查

Public title:

Multi-center, prospective, observational survey of malnutrition risk evaluation in hospitalized patients

注册题目简写:

English Acronym:

MOMENT

研究课题的正式科学名称:

中国患者住院期间营养状态变化的多中心动态调查

Scientific title:

Multi-center, prospective, observational survey of malnutrition risk evaluation in hospitalized 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:

朱明炜 

研究负责人:

韦军民 

Applicant:

Zhu MingWei 

Study leader:

Wei Junmin 

申请注册联系人电话:

Applicant telephone:

+86 13801011304

研究负责人电话:

Study leader's
telephone:

+86 18601880001

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:

zhumw2013@163.com

研究负责人电子邮件:

Study leader's E-mail:

weijunmin@263.net

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:

北京市东城区东单大华路1号

研究负责人通讯地址:

北京市东城区东单大华路1号

Applicant address:

No.1, DahuaLu, DongCheng district, Beijing

Study leader's address:

No.1, DahuaLu, DongCheng district, Beijing

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:

北京医院

Applicant's institution:

Beijing Hospital

研究负责人所在单位:

Affiliation of the Leader:

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2014BJYYEC-022-02

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:

卫生部北京医院伦理委员会

Name of the ethic committee:

The Ministry of health ethics committee of Beijing Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2014-04-16 00:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

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:

卫生部北京医院

Primary sponsor:

Beijing Hospital

研究实施负责(组长)单位地址:

北京市东城区东单大华路1号

Primary sponsor's address:

No.1, DahuaLu, DongCheng district, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

雅培贸易(上海)有限公司

Source(s) of funding:

Abbott Laboratories Trading (Shanghai) Co., Ltd.

研究疾病:

营养不良  

Target disease:

malnutrition

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:

I期临床试验 

Study phase:

1

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

在全国多家三级甲等综合医院的内外科多个专业,同时平行开展调查,应用SGA和NRS2002工具了解中国汉族住院患者住院和出院时的营养状态,动态分析其变化过程。  

Objectives of Study:

A parallel investigation was involved in multi-specialty of many national grade 3 general hospitals. The aim of this study was to investigate the nutritional status before and after hospitalization and perform the dynamic analysis of the change process among Han Chinese patients in hospital by using SGA and NRS2002.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1)年龄 < 18岁;
2)住院时间少于7天或大于30天;
3)次日8时前进行手术者;
4)神志不清楚;
5)拒绝接受评定的住院患者。

Exclusion criteria:

1) age younger than 18;
2) Hospital stays were less than 7 days or more than 30 days;
3) Patients took the surgery before 8.00 am next day;
4) without consciousness;
5) Refuse to participate in the study and hospitalization.

研究实施时间:

Study execute time:

From 2014-06-16 00:00:00 To 1990-01-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2014-06-16 00:00:00 To 1990-01-01 00:00:00

干预措施:

Interventions:

组别:

All population

样本量:

5000

Group:

All population

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

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):

湖南中医药大学第一附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

The First Hospital of Hunan University of Chinese Medicine

Level of the institution:

class A tertiary hospital

国家:

中国

省(直辖市):

China 

市(区县):

陕西 

Country:

Shanxi

Province:

City:

单位(医院):

陕西省中医医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shanxi Provincial Hospital of TCM

Level of the institution:

class A tertiary hospital

国家:

中国

省(直辖市):

甘肃 

市(区县):

 

Country:

China

Province:

Gansu

City:

单位(医院):

甘肃省中医院 

单位级别:

三级甲等医院 

Institution
hospital:

Gansu Hospital of TCM

Level of the institution:

class A tertiary hospital

国家:

中国

省(直辖市):

安徽 

市(区县):

 

Country:

China

Province:

Anhui

City:

单位(医院):

安徽中医药大学第一附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

The First Hospital of Anhui University of Chinese Medicine

Level of the institution:

class A tertiary hospital

国家:

中国

省(直辖市):

江苏 

市(区县):

 

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省中医院 

单位级别:

三级甲等医院 

Institution
hospital:

Jiangsu Province Hospital of TCM

Level of the institution:

class A tertiary hospital

国家:

中国

省(直辖市):

上海 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

上海长征医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Changzheng hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

山东 

市(区县):

 

Country:

China

Province:

Shandong

City:

单位(医院):

青岛大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

QingDao university affilited hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

上海 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属中山医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated FuDan university ZhongShan hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

上海 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

上海同济医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Tongji hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

上海 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai No.6 People's Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

上海 

市(区县):

 

Country:

China

Province:

Shanghai

City:

单位(医院):

上海华东医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Huadong Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

江苏 

市(区县):

 

Country:

China

Province:

Jiangsu

City:

单位(医院):

南京军区总医院 

单位级别:

三级甲等 

Institution
hospital:

General Hospital of Nanjing Military Region

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

江苏 

市(区县):

 

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省人民医院 

单位级别:

三级甲等 

Institution
hospital:

People's Hospital of Jiangsu Province

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

江苏 

市(区县):

 

Country:

China

Province:

Jiangsu

City:

单位(医院):

南京脑科医院 

单位级别:

三级甲等 

Institution
hospital:

Nanjing Brain Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

CHINA

Province:

BEIJING

City:

单位(医院):

中国中医科学院针灸医院 

单位级别:

事业单位 

Institution
hospital:

Acupuncture hospital of China academy of Chinese Medical science

Level of the institution:

public institution

国家:

中国

省(直辖市):

河南 

市(区县):

 

Country:

China

Province:

Henan

City:

单位(医院):

河南省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Henan Provincial People's Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

陕西 

市(区县):

 

Country:

China

Province:

ShanXi

City:

单位(医院):

第四军医大学西京医院 

单位级别:

三级甲等 

Institution
hospital:

Xijin Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

四川 

市(区县):

 

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital of Sichuan University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

四川 

市(区县):

 

Country:

China

Province:

Sichuan

City:

单位(医院):

四川省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Provincial People's Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

新疆 

市(区县):

 

Country:

China

Province:

Xinjiang Uygur Autonomous

City:

单位(医院):

新疆医科大学附属一院 

单位级别:

三级甲等 

Institution
hospital:

First affiliated hospital of Xinjiang Medical Univ

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

重庆 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学一附 

单位级别:

三级甲等 

Institution
hospital:

First affiliated hospital of Chongqing Medical Uni

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

黑龙江 

市(区县):

 

Country:

China

Province:

Heilongjiang

City:

单位(医院):

哈尔滨肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Harbin Tumor Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

黑龙江 

市(区县):

 

Country:

China

Province:

Heilongjiang

City:

单位(医院):

哈尔滨医大二院 

单位级别:

三级甲等 

Institution
hospital:

the second affiliated hospital of Haerbing univers

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

辽宁 

市(区县):

 

Country:

China

Province:

Liaoning

City:

单位(医院):

大连大学附属中山医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Zhongshan Hospital of Dalian University

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

辽宁 

市(区县):

 

Country:

China

Province:

Liaoning

City:

单位(医院):

大连市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Dalian Central Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

辽宁 

市(区县):

 

Country:

China

Province:

Liaoning

City:

单位(医院):

沈阳军区总医院 

单位级别:

三级甲等 

Institution
hospital:

General Hospital of Shenyang Military Area Command

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

天津 

市(区县):

 

Country:

China

Province:

Tianjin

City:

单位(医院):

天津总医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin General Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

cancer hospital of Beijing university

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

301医院 

单位级别:

三级甲等 

Institution
hospital:

301 Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

复兴医院 

单位级别:

三级甲等 

Institution
hospital:

Fuxing hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京友谊医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Friendship Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京武警总医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Armed Police General Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京协和医院 

单位级别:

三级甲等 

Institution
hospital:

Peking Union Medical College Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

河北 

市(区县):

 

Country:

China

Province:

Hebei

City:

单位(医院):

河北省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Hebei People's Hospital

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

主观全面评定法

指标类型:

主要指标

Outcome:

SGA

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

营养风险筛查

指标类型:

主要指标

Outcome:

NRS2002

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

实验室指标

指标类型:

次要指标

Outcome:

lab index

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人体测量指标

指标类型:

次要指标

Outcome:

anthropometric parameters

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出院时临床指标

指标类型:

次要指标

Outcome:

clinical outcome When discharged from hospital

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:

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 100 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):

N/A

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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):

是否共享原始数据:

IPD sharing

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):

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:

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2014-09-25 12:21:58