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

Sichuan Baili Pharmaceutical

Status: Unknown

Conditions: Ventricular Fibrillation; Ventricular Tachycardia

Treatments: Drug: Nifekalant hydrochloride

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03853369

NPMR01/ GUSU18002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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