NCT03853369

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Tachycardia
• Ventricular Fibrillation

Interventions

Type	Name	Description
DRUG	Nifekalant hydrochloride	Treatment is not limited. Patients who have used or will use Nifekalant hydrochloride.

Timeline

• Start date: 2019-02-18
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2019-02-25
• Last updated: 2019-03-14

Locations

1 site across 1 country: China