Clinical trial NCT03853369: Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
Official title: Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Keywords: ventricular tachycardia
ventricular fibrillation
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University First Hospital
name: Beijing Hospital
First posted: 2019-02-25
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with life-threatening ventricular tachycardia or ventricular fibrillation in cases where other drugs are ineffective or inoperable.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: The rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.
timeFrame: From the beginning of the administration to 48 hours after the end of the administration.
Secondary outcomes:
measure: Number of Participants with adverse events
timeFrame: From the beginning of the administration to 48 hours after the end of the administration.
measure: Heart rate
timeFrame: 3 days before the beginning of the administration to 48 hours after the end of the administration.
measure: The survival rate
timeFrame: 30 days after the end of administration.
measure: Blood pressure
timeFrame: 3 days before the beginning of the administration to 48 hours after the end of the administration.
measure: Respiratory rate
timeFrame: 3 days before the beginning of the administration to 48 hours after the end of the administration.
measure: Body temperature
timeFrame: 3 days before the beginning of the administration to 48 hours after the end of the administration.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Yong Huo
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Jing Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Min Yi Cui
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Hospital
name: Xin Hu
role: PRINCIPAL_INVESTIGATOR
References: