Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
研究概览
详细说明
Subjects enrolled in the retrospective study may be enrolled in a prospective study if the study drug is re-used, but in the end only the most-registered case of the subject would be collected.
The recommended treatment plan for this study is from the usage and dosage of NIF. The clinician can make appropriate adjustments to the specific usage and dosage according to the patient's condition.
Load dose: Adults usually use 0.3mg/kg each time, under continuous ECG monitoring, the injection should be completed within 5 minutes, and the maximum dose should not exceed 0.5 mg/kg.
Maintenance dose: After load injection, the adult routine dose is 0.4 mg/kg/h under continuous ECG monitoring. The dosage could be appropriately increased or decreased according to the patient's reaction, but the maximum dose should not exceed 0.8 mg/kg/h.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100000
- 招聘中
- Peking University First Hospital
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接触：
- Jing Zhou
- 电话号码：+86-136 5118 5517
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients with life-threatening ventricular tachycardia or ventricular fibrillation in cases where other drugs are ineffective or inoperable.
- Patients who have received or are about to receive Nifekalant Hydrochloride for treatment according to the instructions.
Exclusion Criteria:
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学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.
大体时间：From the beginning of the administration to 48 hours after the end of the administration.
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The efficiency during the treatment and observation periods, including the rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.
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From the beginning of the administration to 48 hours after the end of the administration.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants with adverse events
大体时间：From the beginning of the administration to 48 hours after the end of the administration.
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Number of Participants with Tdp, ventricular tachycardia or ventricular fibrillation.
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From the beginning of the administration to 48 hours after the end of the administration.
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Heart rate
大体时间：3 days before the beginning of the administration to 48 hours after the end of the administration.
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The subjects' heart rate will be recorded and the abnormalities will be analyzed.
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3 days before the beginning of the administration to 48 hours after the end of the administration.
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The survival rate
大体时间：30 days after the end of administration.
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The 30 days survival rate.
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30 days after the end of administration.
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Blood pressure
大体时间：3 days before the beginning of the administration to 48 hours after the end of the administration.
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Both systolic and diastolic pressures will be assessed during the study period.
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3 days before the beginning of the administration to 48 hours after the end of the administration.
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Respiratory rate
大体时间：3 days before the beginning of the administration to 48 hours after the end of the administration.
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The respiratory status of all subjects will be recorded the incidence of abnormalities will be calculated.
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3 days before the beginning of the administration to 48 hours after the end of the administration.
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Body temperature
大体时间：3 days before the beginning of the administration to 48 hours after the end of the administration.
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The subjects' temperatures will be recorded and the abnormalities will be analyzed.
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3 days before the beginning of the administration to 48 hours after the end of the administration.
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合作者和调查者
调查人员
- 首席研究员：Jing Zhou、Peking University First Hospital
- 首席研究员：Min Yi Cui、Peking University First Hospital
- 首席研究员：Xin Hu、Beijing Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.