Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.
NCT ID: NCT03855826
Last Updated: 2019-02-27
Study Results
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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UNKNOWN
PHASE4
756 participants
INTERVENTIONAL
2019-01-15
2020-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nifekalant Hydrochloride
Nifekalant hydrochloride (50mg) should be dissolved into a 50ml dilution solution (0.9% sodium chloride injection or 5% glucose injection), and configured as 1mg/ml solution of nificaine hydrochloride. The dosage should be taken as needed. The diluted solution should be used within 24 hours. The amount of fluid per hour should not exceed 50ml when intravenously infused. It is recommended to use intravenous pump.
Nifekalant hydrochloride
Both groups were given conventional treatment except for arrhythmia drugs.Only nyficarine hydrochloride or amiodarone hydrochloride could be used according to random results, and the antiarrhythmic drugs should be replaced according to the protocol rules.
Amiodarone
The concentration of more than 2 ampoule amiodarone injection in 500 ml (only isotonic grape solution) is suitable. Amiodarone should be administered as far as possible via the central venous route (administered separately).
Amiodarone
Both groups were given conventional treatment except for arrhythmia drugs.Only nyficarine hydrochloride or amiodarone hydrochloride could be used according to random results, and the antiarrhythmic drugs should be replaced according to the protocol rules.
Interventions
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Nifekalant hydrochloride
Both groups were given conventional treatment except for arrhythmia drugs.Only nyficarine hydrochloride or amiodarone hydrochloride could be used according to random results, and the antiarrhythmic drugs should be replaced according to the protocol rules.
Amiodarone
Both groups were given conventional treatment except for arrhythmia drugs.Only nyficarine hydrochloride or amiodarone hydrochloride could be used according to random results, and the antiarrhythmic drugs should be replaced according to the protocol rules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old, gender is not limited.
Exclusion Criteria
* Patients with torsades de pointes (Tdp);
* Patients with Brugada syndrome;
* Patients with severe atrioventricular block and without pacing protection;
* Patients with hypertrophic cardiomyopathy (HCM) with ventricular septal thickness or (and) left ventricular wall ≥ 15 mm;
* Pregnant or lactating women;
* Patients who are not suitable for the study, considered by investigators.
18 Years
ALL
No
Sponsors
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Sichuan Baili Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ling Ya Han
Role: PRINCIPAL_INVESTIGATOR
Shenyang Military Region General Hospital
Locations
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Shenyang Military Region General Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Other Identifiers
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NTFS01
Identifier Type: -
Identifier Source: org_study_id
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