Ventricular TachycardiaNCT03853369
Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation
- What is being tested?
- Nifekalant hydrochloride
- Type of treatment
- Injection or infusion
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2019to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with life-threatening ventricular tachycardia or ventricular fibrillation in cases where other drugs are ineffective or inoperable.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100000
Jing Zhou, +86-136 5118 5517
About this study
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.
Read the 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.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- Nifekalant hydrochloride
- Keywords
- ventricular tachycardia, ventricular fibrillation
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifekalant hydrochlorideDrug
Also called Nifekalant Hydrochloride for Injection
Treatment is not limited. Patients who have used or will use Nifekalant hydrochloride.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the beginning of the administration to 48 hours after the end of the administration.
Secondary outcomes (6)
Number of Participants with adverse events
Number of Participants with Tdp, ventricular tachycardia or ventricular fibrillation.
Measured: From the beginning of the administration to 48 hours after the end of the administration.
Heart rate
The subjects' heart rate will be recorded and the abnormalities will be analyzed.
Measured: 3 days before the beginning of the administration to 48 hours after the end of the administration.
The survival rate
The 30 days survival rate.
Measured: 30 days after the end of administration.
Blood pressure
Both systolic and diastolic pressures will be assessed during the study period.
Measured: 3 days before the beginning of the administration to 48 hours after the end of the administration.
Respiratory rate
The respiratory status of all subjects will be recorded the incidence of abnormalities will be calculated.
Measured: 3 days before the beginning of the administration to 48 hours after the end of the administration.
Body temperature
The subjects' temperatures will be recorded and the abnormalities will be analyzed.
Measured: 3 days before the beginning of the administration to 48 hours after the end of the administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start18 Feb 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital, Beijing Hospital
- Responsible party
- Sponsor
- Investigators
- Yong Huo, Principal investigator, Peking University First HospitalJing Zhou, Principal investigator, Peking University First HospitalMin Yi Cui, Principal investigator, Peking University First HospitalXin Hu, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853369
- Sponsor's protocol ID
- NPMR01/ GUSU18002
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
- ClinicalTrials.gov ID
- NCT03853369
- Acronym / sponsor ID
- NPMR01/ GUSU18002
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Keywords
- ventricular tachycardia, ventricular fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University First Hospital, Beijing Hospital
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with life-threatening ventricular tachycardia or ventricular fibrillation in cases where other drugs are ineffective or inoperable.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifekalant hydrochlorideAlso: Nifekalant Hydrochloride for InjectionTreatment is not limited. Patients who have used or will use Nifekalant hydrochloride. | Drug | – |
Primary outcome
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.
6 secondary outcomes
Number of Participants with adverse events
Time frame: 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 survival rate
Time frame: 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.
Respiratory rate
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Huo principal investigator
Peking University First Hospital
Jing Zhou principal investigator
Peking University First Hospital
Min Yi Cui principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Xiong (+86-028-85320612, xiongjing@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.