Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection

Conditions
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Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
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* Drug: Nifekalant hydrochloride


Participation Criteria
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Eligibility Criteria
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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: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nifekalant hydrochloride|Treatment is not limited. Patients who have used or will use Nifekalant hydrochloride.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse. | The efficiency during the treatment and observation periods, including the rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse. | From the beginning of the administration to 48 hours after the end of the administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with adverse events | Number of Participants with Tdp, ventricular tachycardia or ventricular fibrillation. | From the beginning of the administration to 48 hours after the end of the administration. | 
| Heart rate | The subjects' heart rate will be recorded and the abnormalities will be analyzed. | 3 days before the beginning of the administration to 48 hours after the end of the administration. | 
| The survival rate | The 30 days survival rate. | 30 days after the end of administration. | 
| Blood pressure | Both systolic and diastolic pressures will be assessed during the study period. | 3 days before the beginning of the administration to 48 hours after the end of the administration. | 
| Respiratory rate | The respiratory status of all subjects will be recorded the incidence of abnormalities will be calculated. | 3 days before the beginning of the administration to 48 hours after the end of the administration. | 
| Body temperature | The subjects' temperatures will be recorded and the abnormalities will be analyzed. | 3 days before the beginning of the administration to 48 hours after the end of the administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventricular tachycardia, ventricular fibrillation