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

NCT ID: NCT03853369

Last Updated: 2019-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-18

Study Completion Date

2019-12-30

Brief Summary

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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

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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

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Ventricular Tachycardia Ventricular Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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Nifekalant hydrochloride

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

Intervention Type DRUG

Other Intervention Names

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Nifekalant Hydrochloride for Injection

Eligibility Criteria

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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

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yong Huo

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Jing Zhou

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Min Yi Cui

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Xin Hu

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Xiong

Role: CONTACT

+86-028-85320612

Facility Contacts

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Jing Zhou

Role: primary

+86-136 5118 5517

Other Identifiers

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NPMR01/ GUSU18002

Identifier Type: -

Identifier Source: org_study_id

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