Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.
研究概览
简要总结
Retrospective and Prospective single arm, observational study to evaluate efficacy and safety of NIF in the treatment of ventricular tachycardia and ventricular fibrillation. The information registration of the target population will be collected with the hospital HIS system or LIS system.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
The rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.
时间窗: From the beginning of the administration to 48 hours after the end of the administration.
The efficiency during the treatment and observation periods, including the rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.
次要结局
- Number of Participants with adverse events(From the beginning of the administration to 48 hours after the end of the administration.)
- Blood pressure(3 days before the beginning of the administration to 48 hours after the end of the administration.)
- Respiratory rate(3 days before the beginning of the administration to 48 hours after the end of the administration.)
- Heart rate(3 days before the beginning of the administration to 48 hours after the end of the administration.)
- The survival rate(30 days after the end of administration.)
- Body temperature(3 days before the beginning of the administration to 48 hours after the end of the administration.)