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

• Conditions: Ventricular Fibrillation; Ventricular Tachycardia

• Registration Number: NCT03853369
• Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-13
• Study Start: 2019-02-18
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-14
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	The efficiency during the treatment and observation periods, including the rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China