注册号: Registration number: |
ChiCTR-TRC-13003534 |
最近更新日期: Date of Last Refreshed on: |
2018-06-16 |
注册时间: Date of Registration: |
2013-06-24 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
评价血必净注射液对重症肺炎疗效的随机、对照、多中心临床试验 |
Public title: |
Efficacy evaluation of Xuebijing injection on severe pneumonia: a randomized controlled multi-center clinical trial |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
评价血必净注射液对重症肺炎疗效的随机、安慰剂平行对照、多中心临床试验 |
Scientific title: |
Efficacy evaluation of Xuebijing injection on severe pneumonia: a randomized placebo-controlled multi-center clinical trial |
研究课题代号(代码): Study subject ID: |
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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: |
宋元林 |
研究负责人: |
白春学 |
Applicant: |
Song Yuanlin |
Study leader: |
Bai Chunxue |
申请注册联系人电话: Applicant telephone: |
+86 15021757762 |
研究负责人电话: Study leader's telephone: |
+86 18621170011 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
ylsong70@163.com |
研究负责人电子邮件: Study leader's E-mail: |
bai.chunxue@zs-hospital.sh.cn |
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): |
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申请注册联系人通讯地址: |
上海市徐汇区枫林路180号 |
研究负责人通讯地址: |
上海市徐汇区枫林路180号 |
Applicant address: |
180 Fenglin Road, Xuhui District, Shanghai, China |
Study leader's address: |
180 Fenglin Road, Xuhui District, Shanghai, 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: |
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申请人所在单位: |
复旦大学附属中山医院 |
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Applicant's institution: |
Zhongshan Hospital, Fudan University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2011-38(3) |
伦理委员会批件附件: Approved file of Ethical Committee: |
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批准本研究的伦理委员会名称: |
复旦大学附属中山医院伦理委员会 |
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Name of the ethic committee: |
Zhongshan Hospital, Fudan University Ethics Committee |
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伦理委员会批准日期: Date of approved by ethic committee: |
2013-06-24 | ||
伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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: |
复旦大学附属中山医院 |
Primary sponsor: |
Zhongshan Hospital Fudan Unversity |
研究实施负责(组长)单位地址: |
上海市徐汇区枫林路180号 |
Primary sponsor's address: |
180 Fenglin Road, Xuhui District, Shanghai, China |
试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
天津市科学技术委员会 |
Source(s) of funding: |
Tianjin Science and Technology committee |
研究疾病: |
重症社区获得性肺炎 |
Target disease: |
Severe Community Acquired Pneumonia |
研究疾病代码: |
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Target disease code: |
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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: |
4 |
研究目的: |
评价血必净注射液治疗重症社区获得性肺炎的有效性 |
Objectives of Study: |
To evaluate the efficacy of Xuebijing injection in the treatment of severe community acquired pneumonia. |
药物成份或治疗方案详述: |
试验组和对照组分别在常规治疗基础上给予血必净注射液100ml+0.9%氯化钠注射液100ml,q12h,或0.9%氯化钠注射液200ml,q12h |
Description for medicine or protocol of treatment in detail: |
The experimental group and the control group were given Xuebijing injection 100ml+ 0.9% saline injection 100ml, q12h or 0.9% saline injection 200ml, q12h plus a standard therapy |
研究设计: |
随机平行对照 |
Study design: |
Parallel |
纳入标准: |
1)签署知情同意书; 2)年龄18-75周岁; 3)体重≥40kg且≤100kg; 4)入院时或入院不超过48小时,出现社区获得性肺炎的临床症状,符合重症社区获得性肺炎诊断标准(依据美国胸科学会定义),符合下列标准中的三项或三项以上:PaO2/FiO2 ≤250;呼吸频率 ≥ 30次/分;尿素氮>20mg/dl;感染致白细胞减少(白细胞计数<4000/mm3);血小板减少(血小板计数<100,000/mm3);低体温(体温<36℃);意识模糊,定向力障碍;低血压需要积极的液体复苏;符合社区获得性肺炎诊断的新出现肺部浸润的X线表现。住ICU的重症肺炎患者符合以下标准其中任何一项也可纳入:需要机械通气;感染性休克需要血管活性药升压治疗。 |
Inclusion criteria |
Provide signed informed consent, aged 18 to 75 years, weight ≥40 kg and ≤100 kg, clinical symptoms suggestive of community-acquired pneumonia, acquired outside of the hospital or less than 48 hours after hospital admission, met SCAP criteria (defined by the American Thoracic Society) fulfilled three or more of the following criteria: PaO2/FiO2 ratio ≤250 mmHg, respiratory rate ≥30 breaths/min, blood urea nitrogen (BUN) >20 mg/dL, leukopenia (white blood cell count (WBC) <4000 cells/ mm3) not due to other causes, thrombocytopenia (platelet count<100,000 cells/mm3), hypothermia (core temperature <36 degree C), new onset mental confusion, receiving treatment with vasopressors at therapeutic doses after adequate fluid resuscitation, or radiographic findings on new pulmonary infiltrate(s) consistent with CAP diagnosis. Patients with pneumonia of sufficient severity requiring ICU management and patients meeting at least one of the severity criteria, such as receiving mechanical ventilatory support or septic shock with the need for vasopressors, were also included in the study) |
排除标准: |
1)患者预期寿命≤48小时;2)孕妇、哺乳期妇女;3)严重原发性疾病;4)使用免疫抑制剂和/或细胞毒性药物;5)肺部肿瘤致阻塞性肺炎;6)精神病患者;7)过敏体质者(≥两种物质过敏);8)30天内参加过其他临床试验者;9)近7天内使用过禁用药物者;10)明确诊断为严重ARDS者(多肺叶浸润,氧合指数<100mmHg);研究者判断不能完成试验者。 |
Exclusion criteria: |
Life expectancy was 48 hours or less, pregnant or lactating, diagnosed with severe primary diseases, using immunosuppressants and/or cytotoxic drugs, diagnosed with lung disease induced by obstructive lung tumors, diagnosed with psychiatric disorders, or if allergic to two or more substances. Further exclusion criteria included concurrently participating in other clinical trials within 30 days before enrollment, use of prohibited medicine within 7 days before enrollment, and a diagnosis of severe acute respiratory distress syndrome (ARDS) (if patient had multi-lobar infiltrates, a low PaO2/FiO2 ratio (<100 mmHg) and met the definition of severe ARDS, he/she was excluded), could not complete the study judged by investigators. |
研究实施时间: Study execute time: |
从From2013-09-01至To 2016-06-30 |
征募观察对象时间: Recruiting time: |
从From2013-09-01至To 2016-06-30 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
由独立的第三方通过中心随机化系统,采用动态最小化随机方法实施。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
By an independent third party through the central randomization tem that uses dynamic stochastic |
盲法: |
由于中心随机化系统的研究者权限和药物管理员权限各自独立,由研究者和药品管理员分别登录操作。研究者权限下的受试者组别由随机化系统隐藏。在电子和纸质CRF中仅体现受试者随机号,不体现受试者组别。因此研究者和最终评价者在随访和评价时均不知道受试者组别。 两组使用的研究药物均采用避光输液器和遮光罩遮挡输注,避免受试者了解所在组别。 |
Blinding: |
As central randomization tem researchers privileges drug administrator privileges independently by researchers pharmaceutical administrators to log on separately operation. Groups of investigators under the authority of the subjects by the random tem hidden. In the electronic paper CRF random numbers only reflect the subjects, the subjects do not reflect the . Therefore, researchers evaluators at the final follow-up evaluation are unaware subjects s. Two drugs used in the study are used dark infusion transfusion hood cover, avoiding subjects understwhere s. |
是否共享原始数据: IPD sharing |
是Yes |
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): |
天津中医药临床评价研究所 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Tianjin Institute of Clinical Evaluation |
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: |
天津中医药临床评价研究所 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Tianjin Institute of Clinical Evaluation |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |