Today is 2020-09-28

Intravenous Midazolam Versus Diazepam for Management of Non-Convulsive Status Epilepticus with Unknown Time of Symptom Onset: a Randomized Controlled Study
download

注册号:

Registration number:

ChiCTR1900027967 

最近更新日期:

Date of Last Refreshed on:

2019-12-15 

注册时间:

Date of Registration:

2019-12-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

咪达唑仑与地西泮在时间窗不明的非惊厥癫痫持续状态中的疗效及安全性比较 

Public title:

Intravenous Midazolam Versus Diazepam for Management of Non-Convulsive Status Epilepticus with Unknown Time of Symptom Onset: a Randomized Controlled Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

咪达唑仑与地西泮在时间窗不明的非惊厥癫痫持续状态中的疗效及安全性比较 

Scientific title:

Intravenous Midazolam Versus Diazepam for Management of Non-Convulsive Status Epilepticus with Unknown Time of Symptom Onset: a Randomized Controlled Study 

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:

黄琪 

研究负责人:

吴原 

Applicant:

Huang Qi 

Study leader:

Wu Yuan 

申请注册联系人电话:

Applicant telephone:

+86 13687889510 

研究负责人电话:

Study leader's telephone:

+86 13607713316 

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:

hq2907xx@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wuyuan90@126.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:

广西南宁市青秀区双拥路6号 

研究负责人通讯地址:

广西南宁市青秀区双拥路6号 

Applicant address:

6 Shuangyong Road, Qingxiu District, Nanning, Guangxi, China 

Study leader's address:

6 Shuangyong Road, Qingxiu District, Nanning, Guangxi, China 

申请注册联系人邮政编码:

Applicant postcode:

530021 

研究负责人邮政编码:

Study leader's postcode:

530021 

申请人所在单位:

广西医科大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital to Guangxi Medical 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:

快审2019第(069)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:

广西医科大学第一附属医院医学伦理委员会 

Name of the ethic committee:

The Ethics Committee of the First Affiliated Hospital to Guangxi Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-03 

伦理委员会联系人:

薄占东 

Contact Name of the ethic committee:

Bo Zhandong 

伦理委员会联系地址:

广西南宁市青秀区双拥路6号 

Contact Address of the ethic committee:

6 Shuangyong Road, Qingxiu District, Nanning, Guangxi, 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:

广西医科大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital to Guangxi Medical University 

研究实施负责(组长)单位地址:

广西南宁市青秀区双拥路6号 

Primary sponsor's address:

6 Shuangyong Road, Qingxiu District, Nanning, Guangxi, 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):

广西

市(区县):

南宁

Country:

China

Province:

Guangxi

City:

Nanning

单位(医院):

广西医科大学第一附属医院

具体地址:

青秀区双拥路6号

Institution
hospital:

The First Affiliated Hospital to Guangxi Medical University

Address:

6 Shuangyong Road, Qingxiu District

经费或物资来源:

中国国家自然科学基金(基金号:81760242) 

Source(s) of funding:

National Natural Science Foundation, China (No. 81760242) 

研究疾病:

癫痫持续状态 

Target disease:

Status Epilepticus 

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:

1. 比较静脉注射咪达唑仑与地西泮在时间窗不明的非惊厥持续状态中的有效性及安全性; 2. 评估影响时间窗不明的非惊厥持续状态的预后因素。 

Objectives of Study:

1. To evaluate the clinical efficacy and adverse reaction of intravenous midazolam versus diazapam as a first line option for non-convulsive status epilepticus with unknown time of symptom onset. 2. To identify the prognostic factors of non-convulsive status epilepticus with unknown time of symptom onset. 

药物成份或治疗方案详述:

1. 咪达唑仑组:咪达唑仑0.2mg/kg静脉推注后,以0.2mg/kg/h静脉维持24小时。 2. 地西泮组:地西泮10mg/kg静脉推注后,以8mg/h静脉维持24小时。 

Description for medicine or protocol of treatment in detail:

1. Midazolam Group: Patients receive intravenous 0.2mg/kg of midazolam, followed by 0.2mg/kg/h of midazolam for 24 hours. 2. Diazapam Group: Patients receive intravenous 10mg of diazapam, followed by 8mg/h of diazapam for 24 hours. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 年龄>18岁; 2. Glasgow评分≤8分; 3. 昏迷超过1小时; 4. 脑电图提示NCSE。 

Inclusion criteria

1. Aged >18 years. 2. Glasgow scale <= 8. 3. Persistent time of coma >= 1h. 4. Ictal discharge was detected by electroencephalogram. 

排除标准:

1. 既往诊断为癫痫性脑病; 2. 惊厥持续状态; 3. 使用了其他的静脉抗癫痫药物; 4. 严重的肝、肾功能障碍。 

Exclusion criteria:

1. Patients diagnosed with epileptic encephalitis prior to the onset of non-convulsive status epilepticus. 2. Convulsive status epilepticus. 3. Using other intravenous anti-epileptic drugs. 4. Serious hepatic or renal dysfunction. 

研究实施时间:

Study execute time:

From2020-01-01To 2022-07-01 

征募观察对象时间:

Recruiting time:

From2020-01-01To 2022-03-01 

干预措施:

Interventions:

组别:

咪达唑仑组

样本量:

35

Group:

Midazolam Group

Sample size:

干预措施:

咪达唑仑静脉注射

干预措施代码:

Intervention:

intravenous midazolam

Intervention code:

组别:

地西泮组

样本量:

35

Group:

Diazapam Group

Sample size:

干预措施:

地西泮静脉注射

干预措施代码:

Intervention:

intravenous diazapam

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广西 

市(区县):

南宁 

Country:

China 

Province:

Guangxi 

City:

Nanning 

单位(医院):

广西医科大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital to Guangxi Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

14天内非惊厥癫痫持续状态的复发率

指标类型:

主要指标 

Outcome:

The recurrence rate of NCSE within 14 days

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

14天内Glasgow评分>14的发生率

指标类型:

次要指标 

Outcome:

The ratio of patients with Glasgow score > 14 within 14 days

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗结束30天后平均mRS评分

指标类型:

次要指标 

Outcome:

The mean of mRS score after 30 days

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

入住ICU的平均时间

指标类型:

次要指标 

Outcome:

The mean length of intensive care unit admission

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

入住医院的平均时间

指标类型:

次要指标 

Outcome:

The mean length of hospital admission

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天内死亡率

指标类型:

副作用指标 

Outcome:

Motality within 30 days

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天内呼吸抑制发生率

指标类型:

副作用指标 

Outcome:

Respiratory adverse events within 30 days

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天内循环抑制发生率

指标类型:

副作用指标 

Outcome:

Cardiovascular adverse events within 30 days

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天内过敏发生率

指标类型:

副作用指标 

Outcome:

The ratio of allergy within 30 days

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

30天内血栓性静脉炎发生率

指标类型:

副作用指标 

Outcome:

The ratio of thrombophlebitis within 30 days

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

药物静推10分钟内发作期放电控制率

指标类型:

次要指标 

Outcome:

The remission rate of NCSE within 10 minutes

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

14 天内 Glasgow 评分平均好转程度

指标类型:

主要指标 

Outcome:

The change from baseline in mean daily Glasgow score during the days 1-14

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:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 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):

1-分层随机化,按疾病种类分层; 2-利用Stata产生随机数字表。

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

1-Stratified randomization according to the etiology. 2-The randomization sequences were generated by using Stata.

盲法:

1. 受试对象为昏迷患者,均被盲。 2. 医师A仅负责非癫痫持续状态的判别及药物的使用;药物的疗效及安全性的评估由研究者B及研究者C独立完成;数据的统计分析由研究者D独立完成。研究者B、C、D对患者药物使用情况不清。

Blinding:

1. All participants were blinded because of the state of coma. 2. Except for the doctors, all relevant parties were blinded to the intervention groups.

原始数据公开时间:

The time of sharing IPD:

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):

2023-01,通过中国临床试验注册中心公开

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

2023-01,Opened through the China Clinical Trial Registration Center

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:

病例记录表

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

cace record form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-07
return list