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OPRM1和CYP3A41G基因多态性对脓毒症患者阿片类药物药效学的影响
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注册号:

Registration number:

ChiCTR2000034581 

最近更新日期:

Date of Last Refreshed on:

2020-07-11 

注册时间:

Date of Registration:

2020-07-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

OPRM1和CYP3A41G基因多态性对脓毒症患者阿片类药物药效学的影响 

Public title:

Effects of OPRM1 and CYP3A41G gene polymorphisms on opioid pharmacodynamics in sepsis patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

OPRM1和CYP3A41G基因多态性对脓毒症患者阿片类药物药效学的影响 

Scientific title:

Effects of OPRM1 and CYP3A41G gene polymorphisms on opioid pharmacodynamics in sepsis 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:

郭鸿 

研究负责人:

郭鸿 

Applicant:

Guo Hong 

Study leader:

Guo Hong 

申请注册联系人电话:

Applicant telephone:

+86 13893475589 

研究负责人电话:

Study leader's telephone:

+86 13893475589 

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:

guohong980324@163.com 

研究负责人电子邮件:

Study leader's E-mail:

guohong980324@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:

甘肃省兰州市东岗西路1号 

研究负责人通讯地址:

甘肃省兰州市东岗西路1号 

Applicant address:

1 Donggang Road West, Lanzhou, Gansu  

Study leader's address:

1 Donggang Road West, Lanzhou, Gansu  

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:

兰州大学第一医院 

Applicant's institution:

The First Hospital of Lanzhou 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:

LDYYLL2020-240 

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:

兰州大学第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Hospital of Lanzhou University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-07-08 

伦理委员会联系人:

郭顺林 

Contact Name of the ethic committee:

Guo Shun-Lin 

伦理委员会联系地址:

甘肃省兰州市东岗西路1号 

Contact Address of the ethic committee:

1 Donggang Road West, Lanzhou, Gansu  

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:

兰州大学第一医院 

Primary sponsor:

The First Hospital of Lanzhou University 

研究实施负责(组长)单位地址:

甘肃省兰州市东岗西路1号 

Primary sponsor's address:

1 Donggang Road West, Lanzhou, Gansu  

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

中国卫生信息与健康医疗大数据学会 

Source(s) of funding:

Chinese medical information and big data association 

研究疾病:

脓毒症 

Target disease:

sepsis 

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:

探索性研究/预试验 

Study phase:

研究目的:

本研究拟对ICU脓毒症患者分析阿片类物质相关基因多态性,根据基因型调整临床使用芬太尼类药物,拟对不同基因分型的脓毒症患者种族、镇痛药物的使用量、住院时长等相关指标进行对比分析,以期更为精准控制镇痛镇静用药量,达到精准用药目标。 

Objectives of Study:

This study intends to analyze opioid related gene polymorphisms in ICU patients with sepsis, adjust the clinical use of fentanyl drugs according to the genotype, and compare and analyze the related indicators of different genotypes of sepsis patients, such as race, dosage of analgesic drugs, length of hospital stay, etc.Our aim is to control the dosage of analgesic and sedative drugs more accurately and achieve the goal of precise drug. 

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.符合脓毒症3.0 诊断标准; 2.18岁的成年病人; 3.镇静目标RASS评分-2到+1分,重度ARDS时使用深镇静; 4.使用芬太尼或舒芬太尼或瑞芬太尼镇痛。 

Inclusion criteria

1. The diagnosis criteria of sepsis 3.0; 2. 18-year-old adult patients; 3. The RASS score of sedation target was - 2 to + 1. Deep sedation was used in severe ARDS; 4. Fentanyl or sufentanil or remifentanil was used for analgesia; 

排除标准:

1. 使用芬太尼或舒芬太尼或瑞芬太尼以外其他药物镇痛的患者; 2. 基础疾病预后恶劣,并可能成为病人死亡主因; 3. 治疗经费紧张,估计不能完成治疗观察者。 

Exclusion criteria:

1. Patients who used fentanyl or sufentanil or remifentanil for analgesia; 2. The prognosis of basic diseases is bad and may become the main cause of death; 3. The treatment cost is tight, and it is estimated that the treatment can not be completed by the observer. 

研究实施时间:

Study execute time:

From2019-09-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2020-12-31 

干预措施:

Interventions:

组别:

case series

样本量:

100

Group:

case series

Sample size:

干预措施:

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):

甘肃 

市(区县):

兰州 

Country:

China 

Province:

Gansu 

City:

Lanzhou 

单位(医院):

兰州大学第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital of Lanzhou University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

OPRM1基因型

指标类型:

主要指标 

Outcome:

OPRM1 genetype

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CYP3A41G基因型

指标类型:

主要指标 

Outcome:

CYP3A41G genetype

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

芬太尼类药物用量

指标类型:

主要指标 

Outcome:

dosage of fentanyl

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

主要指标 

Outcome:

length of hospital time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

机械通气时间

指标类型:

主要指标 

Outcome:

Mechanical ventilation time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SOFA评分

指标类型:

主要指标 

Outcome:

SOFA score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡率

指标类型:

主要指标 

Outcome:

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:

T细胞功能

指标类型:

主要指标 

Outcome:

T cell function

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:

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 90 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):

未使用

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

Not used

盲法:

N/A

Blinding:

N/A

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):

https://www.lzdxdyyy.com/

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

https://www.lzdxdyyy.com/

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:

HIS system

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

HIS system

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-10
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