- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03853369
Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jing Xiong
- Phone Number: +86-028-85320612
- Email: xiongjing@baili-pharm.com
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100000
- Recruiting
- Peking University First Hospital
-
Contact:
- Jing Zhou
- Phone Number: +86-136 5118 5517
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.
Time Frame: From the beginning of the administration to 48 hours after the end of the administration.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with adverse events
Time Frame: From the beginning of the administration to 48 hours after the end of the administration.
|
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.
|
Heart rate
Time Frame: 3 days before the beginning of the administration to 48 hours after the end of the administration.
|
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.
|
The survival rate
Time Frame: 30 days after the end of administration.
|
The 30 days survival rate.
|
30 days after the end of administration.
|
Blood pressure
Time Frame: 3 days before the beginning of the administration to 48 hours after the end of the administration.
|
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.
|
Respiratory rate
Time Frame: 3 days before the beginning of the administration to 48 hours after the end of the administration.
|
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.
|
Body temperature
Time Frame: 3 days before the beginning of the administration to 48 hours after the end of the administration.
|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jing Zhou, Peking University First Hospital
- Principal Investigator: Min Yi Cui, Peking University First Hospital
- Principal Investigator: Xin Hu, Beijing Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NPMR01/ GUSU18002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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