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

Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03853369
• Other study ID #: NPMR01/ GUSU18002
• Status: Recruiting
• Start date: February 18, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2019
• Source: Sichuan Baili Pharmaceutical Co., Ltd.
• Contact: Jing Xiong
• Phone: +86-028-85320612
• Email: xiongjing[@]baili-pharm.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Drug:
• Nifekalant hydrochloride
Treatment is not limited. Patients who have used or will use Nifekalant hydrochloride.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Sichuan Baili Pharmaceutical Co., Ltd.	Beijing Hospital, Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	The survival rate	The 30 days survival rate.	30 days after the end of administration.
Secondary	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.
Secondary	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.
Secondary	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.