今天是:2019-06-20 星期四

早期允许性低热卡高蛋白及免疫增强型肠内营养+肠外支持在机械通气重症患者中的随机对照研究
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注册号:

Registration number:

ChiCTR1900022550 

最近更新日期:

Date of Last Refreshed on:

2019-04-16 

注册时间:

Date of Registration:

2019-04-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

早期允许性低热卡高蛋白及免疫增强型肠内营养+肠外支持在机械通气重症患者中的随机对照研究 

Public title:

High-protein hypocaloric vs high-protein hypocaloric immune-enhanced enteral nutrition vs normocaloric enteral nutrition in critically ill patients with mechanical Ventilation: A randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

早期允许性低热卡高蛋白及免疫增强型肠内营养+肠外支持在机械通气重症患者中的随机对照研究 

Scientific title:

High-protein hypocaloric vs high-protein hypocaloric immune-enhanced enteral nutrition vs normocaloric enteral nutrition in critically ill patients with mechanical Ventilation: A randomized controlled trial 

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:

王沪旭 

研究负责人:

石源 

Applicant:

Huxu Wang 

Study leader:

Yuan Shi 

申请注册联系人电话:

Applicant telephone:

+86 13771607101 

研究负责人电话:

Study leader's telephone:

+86 13801521061 

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:

522894389@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

849267073@qq.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:

江苏省江阴市寿山路163号 

研究负责人通讯地址:

江苏省江阴市寿山路163号 

Applicant address:

163 Shoushan Road, Jiangyin, Jiangsu, China 

Study leader's address:

163 Shoushan Road, Jiangyin, Jiangsu, 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:

南通大学附属江阴人民医院 

Applicant's institution:

Jiangyin People's Hospital affiliated to Nantong University  

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

南通大学附属江阴人民医院 

Primary sponsor:

Jiangyin People's Hospital affiliated to Nantong University  

研究实施负责(组长)单位地址:

江苏省江阴市寿山路163号 

Primary sponsor's address:

163 Shoushan Road, Jiangyin, Jiangsu, 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):

江苏省

市(区县):

江阴市

Country:

China

Province:

Jiangsu

City:

Jiangyin

单位(医院):

南通大学附属江阴人民医院

具体地址:

江苏省江阴市寿山路163号

Institution
hospital:

Jiangyin People's Hospital affiliated to Nantong University

Address:

163 Shoushan Road, Jiangyin, Jiangsu, China

经费或物资来源:

真实世界研究专项基金 

Source(s) of funding:

Real World Research Special Fund 

研究疾病:

机械通气的重症患者 

Target disease:

critically ill patients with mechanical Ventilation 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

评估不同营养风险患者,通过早期(24h内开始)肠内营养,并给予必要的肠外营养补充,给予允许性低热卡及高蛋白营养支持及免疫增强型肠内营养制剂,并通过不同的喂养方式,提高早期肠内营养的耐受性,早期低热卡高蛋白及免疫增强型肠内营养制剂等对Nutric评分不同的患者营养指标的影响,喂养不良事件的影响,对合并感染(7-10d)及预后的影响。 

Objectives of Study:

Patients with different nutritional risks, through early enteral nutrition, and to provide the necessary parenteral nutrition supplement, given permissive low calorie and high protein nutritional support and immune-enhanced enteral nutrition, and through different feeding ways to improve the tolerance of early enteral nutrition. To assess effects of early low-calorie high-protein and immune-enhanced enteral nutrition preparations on nutritional indicators of patients with different Nutric scores, the effects of feeding adverse events, and co-infections (7-10d) and the impact of prognosis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.年龄:18-65岁;2.无法经口进食,需要肠内或肠外营养支持者的机械通气患者;3.预期机械通气时间大于72小时 

Inclusion criteria

Aged 18 to 65 years; Mechanically ventilated patients unable to eat by mouth and need enteral or parenteral nutrition; receiving mechanical ventilation with ≥72 hrs anticipated duration. 

排除标准:

1.既往有胃大部切除,食道切除及肠道切除病史。2.双侧脑疝患者。3.腹膜炎患者.4.合并肠道坏死,肠瘘,机械性肠梗阻患者。5.休克未控制者,未控制的消化道出血患者。6.对营养液成分过敏者,不耐受者。7.孕妇,免疫重大缺陷患者,恶性肿瘤患者。8.肾功能不全,严重肝功能异常者。 

Exclusion criteria:

Previous anatomy-altering upper gastrointestinal surgery, bilateral cerebral palsy, peritonitis, bowel necrosis, bowel fistula, mechanical bowel obstruction, uncontrolled shock,uncontrolled gastrointestinal bleeding, pregnancy, immunodeficiency, malignant tumors, renal insufficiency, severe liver function abnormalities, allergic to nutritional preparation. 

研究实施时间:

Study execute time:

From2019-05-01To 2021-05-31 

干预措施:

Interventions:

组别:

对照组

样本量:

200

Group:

control group

Sample size:

干预措施:

热量25kcal/kg.d,蛋白1.2g/kg.d

干预措施代码:

Intervention:

Calorie 25kcal/kg.d, protein1.2g/kg.d

Intervention code:

组别:

实验组

样本量:

200

Group:

Experimental group 1

Sample size:

干预措施:

热量15kcal/kg.d,蛋白1.7g/kg.d

干预措施代码:

Intervention:

Calorie 15kcal/kg.d, protein1.7g/kg.d

Intervention code:

组别:

免疫组

样本量:

200

Group:

Experimental group 2

Sample size:

干预措施:

热量15kcal/kg.d,蛋白1.7g/kg.d ,采用免疫增强型肠内营养制剂

干预措施代码:

Intervention:

Calorie 15kcal/kg.d, protein1.7g/kg.d,use of immunoenhanced enteral nutrition

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

江阴市 

Country:

China 

Province:

Jiangsu 

City:

Jiangyin City 

单位(医院):

南通大学附属江阴人民医院 

单位级别:

三级甲等 

Institution
hospital:

Jiangyin People's Hospital affiliated to Nantong University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

死亡率

指标类型:

主要指标 

Outcome:

hospital mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃肠道功能

指标类型:

主要指标 

Outcome:

Gastrointestinal function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

营养状态

指标类型:

主要指标 

Outcome:

Nutritional status

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU住院时间

指标类型:

主要指标 

Outcome:

ICU admission to enrolment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫功能指标

指标类型:

主要指标 

Outcome:

Immune function index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能

指标类型:

主要指标 

Outcome:

Liver and kidney function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高血糖及胰岛素应用情况

指标类型:

主要指标 

Outcome:

Hyperglycemic episodes and insulin requirements

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:

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:

标本中文名:

尿液

组织:

Sample Name:

urine

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 65 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):

患者由计算机得出的随机序列被分配到对照组或实验组或免疫增强组。

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

Patients will randomly assigned to control group or test group or immune-enhanced group using a computer-generated randomization schedule。

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

临床营养大数据协作平台 http://www.xn--l6qr5vprzefj.xn--fiqs8s/

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

http://www.xn--l6qr5vprzefj.xn--fiqs8s/

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:

数据收集采用CRF表,电子采集和管理系统使用江阴人民医院信息科和信息公司合作开发的的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:

The data collection adopts the CRF form.The electronic collection and management system jointly developed by the Information Department of Jiangyin People's Hospital and the information company.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-16
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