今天是:2019-11-22 星期五

重型乙型肝炎(肝衰竭)营养干预多中心、前瞻、对照研究
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注册号:

Registration number:

ChiCTR1900025809 

最近更新日期:

Date of Last Refreshed on:

2019-09-09 

注册时间:

Date of Registration:

2019-09-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

重型乙型肝炎(肝衰竭)营养干预多中心、前瞻、对照研究 

Public title:

A multicenter, prospective and controlled study for nutritional intervention in patients with severe hepatitis B (liver failure) 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

重型乙型肝炎(肝衰竭)营养干预多中心、前瞻、对照研究(重型乙型肝炎(肝衰竭)诊治新技术新设备新方案研究及应用的内容之一)  

Scientific title:

A multicenter, prospective and controlled study for nutritional intervention in patients with severe hepatitis B (liver failure) (one topic of the research and application of new technology, new equipment and new scheme of the diagnosis and treatment of severe hepatitis B (liver feilure)) 

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:

刘小丽 

研究负责人:

黄建荣 

Applicant:

Liu Xiaoli 

Study leader:

Huang Jianrong 

申请注册联系人电话:

Applicant telephone:

+86 13738065259 

研究负责人电话:

Study leader's telephone:

+86 0571-87236743 

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:

lxl0209@21cn.com 

研究负责人电子邮件:

Study leader's E-mail:

hzhuangchina@sina.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:

浙江省杭州市庆春路79号浙一医院6号楼10楼人工肝中心 

研究负责人通讯地址:

浙江省杭州市庆春路79号浙一医院6号楼10楼人工肝中心 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China  

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Medical College, Zhejiang 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:

(2019)科研快审第(989)号 

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:

浙江大学医学院附属第一医院科研伦理委员会 

Name of the ethic committee:

Research Ethics Committee of the First Affiliated Hospital, College of medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-04 

伦理委员会联系人:

宋朋红 

Contact Name of the ethic committee:

Song Penghong 

伦理委员会联系地址:

浙江省杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Medical College, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun 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):

浙江大学医学院附属第一医院

具体地址:

庆春路79号

Institution
hospital:

The First Affiliated Hospital of Medical College, Zhejiang University

Address:

79 Qingchun Road

经费或物资来源:

“十三五”国家科技重大专项 

Source(s) of funding:

Major National Science and Technology Projects in the 13th Five-Year Plan 

研究疾病:

重型乙型肝炎(肝衰竭) 

Target disease:

sever hepatitis B (liver failure) 

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:

其它 

Study phase:

N/A 

研究目的:

比较常规自主的营养摄入与个体化设计的营养摄入,对重型乙型肝炎(肝衰竭)患者营养状况、疾病恢复等的影响。 

Objectives of Study:

To compare the effects of routine and individualized nutritional intake on nutritional status and disease recovery in patients with severe hepatitis B (liver failure). 

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) 患者同意参加本研究并签署知情同意书; 2) 性别不限、年龄18-65周岁; 3) HBsAg阳性持续6个月以上并且HBV-DNA阳性(高于200IU/ml); 4) 极度乏力,并有明显厌食、腹胀、恶心、呕吐等严重消化道症状; 5) 短期内黄疸进行性加深(血清总胆红素大于正常值上限10倍或每日上升≥17.1umol/L); 6) 出血倾向明显,PTA≤40%,且排除其他原因; 

Inclusion criteria

1) The patient agrees to participate in the study and sign the informed consent. 2) Unlimited sex, aged 18-65 years; 3) HBsAg positive lasted for more than 6 months and HBV-DNA positive (higher than 200 IU/ml); 4) Extreme fatigue and severe gastrointestinal symptoms such as anorexia, abdominal distension, nausea and vomiting. 5) Progressive deepening of jaundice in a short period of time (serum total bilirubin is 10 times higher than the upper limit of normal value or increases daily by more than 17.1 umol/L); 6) The tendency of bleeding was obvious, PTA was less than 40%, and other causes were excluded. 

排除标准:

1) 急性妊娠脂肪肝; 2) 药物性肝损伤; 3) 酒精性肝病(每日饮酒女性超过20g,男性超过40g,5年以上); 4) 自身免疫性肝病; 5) 先天性代谢性肝病,如Wilson病,血色病等; 6) 移植术后乙肝复发导致重型肝炎者; 7) 合并其他病毒现症感染者:抗-HAV IgM、抗-HCV、抗-HEV IgM、抗HEV-IgG、抗HDV-IgM以及抗HIV抗体任何一项阳性; 8) 合并严重的基础疾病,包括未被控制的有临床意义的心脏、肺、肾脏、消化、神经、精神疾病、免疫性疾病、代谢性疾病、恶性肿瘤等。 

Exclusion criteria:

1) Acute fatty liver of pregnancy; 2) Drug-induced liver injury; 3) Alcoholic liver disease (drinking more than 20 g per day for women, 40 g for men and more than 5 years); 4) Autoimmune liver disease; 5) Congenital metabolic liver diseases, such as Wilson's disease, hemochromatosis, etc.; 6) Severe hepatitis caused by hepatitis B recurrence after transplantation; 7) Patients with other viral infections were positive for anti-HAV IgM, anti-HCV, anti-HEV IgM, anti-HEV-IgG, anti-HDV-IgM and anti-HIV antibodies. 8) Complicated with serious underlying diseases, including uncontrolled clinically significant heart, lung, kidney, digestion, nerve, mental disorders, immune diseases, metabolic diseases, malignant tumors, etc. 

研究实施时间:

Study execute time:

From2019-09-09To 2020-12-31 

干预措施:

Interventions:

组别:

营养干预组

样本量:

30

Group:

Nutrition intervention group

Sample size:

干预措施:

营养干预

干预措施代码:

A

Intervention:

nutritional intervention

Intervention code:

组别:

对照组

样本量:

30

Group:

Control

Sample size:

干预措施:

按自己的意愿摄入营养

干预措施代码:

B

Intervention:

Nutrition intake according to one's own wishes

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):

浙江大学医学院附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Medical College, Zhejiang University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属佑安医院 

单位级别:

三甲 

Institution
hospital:

Affiliated You'an Hospital, Capital Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三甲 

Institution
hospital:

Ruijin Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

人体成分分析

指标类型:

主要指标 

Outcome:

Body Composition Analysis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

主要指标 

Outcome:

liver 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:

每日总能量摄入

指标类型:

主要指标 

Outcome:

Daily total energy intake

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Daily total protein intake

指标类型:

主要指标 

Outcome:

每日总蛋白摄入量

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:

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 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):

简单随机方法(邵丽负责) 请说明具体使用什么方法(统计学软件?随机数字表?或其他)产生随机序列。

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

simple random method by Shao Li.

盲法:

未说明

Blinding:

Not stated

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):

2021年6月

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

统计结果

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:

CRF

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

t检验

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-09-09
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