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Trial record 19 of 132 for:    "Paroxysmal Ventricular Fibrillation"

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

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ClinicalTrials.gov Identifier: NCT03853369
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborators:
Peking University First Hospital
Beijing Hospital
Information provided by (Responsible Party):
Sichuan Baili Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment
Ventricular Tachycardia Ventricular Fibrillation Drug: Nifekalant hydrochloride

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.


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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019



Intervention Details:
  • Drug: Nifekalant hydrochloride
    Treatment is not limited. Patients who have used or will use Nifekalant hydrochloride.
    Other Name: Nifekalant Hydrochloride for Injection


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. The survival rate [ Time Frame: 30 days after the end of administration. ]
    The 30 days survival rate.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853369


Contacts
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Contact: Jing Xiong +86-028-85320612 xiongjing@baili-pharm.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Jing Zhou    +86-136 5118 5517      
Sponsors and Collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Peking University First Hospital
Beijing Hospital
Investigators
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Principal Investigator: Yong Huo Peking University First Hospital
Principal Investigator: Jing Zhou Peking University First Hospital
Principal Investigator: Min Yi Cui Peking University First Hospital
Principal Investigator: Xin Hu Beijing Hospital

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Responsible Party: Sichuan Baili Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03853369     History of Changes
Other Study ID Numbers: NPMR01/ GUSU18002
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sichuan Baili Pharmaceutical Co., Ltd.:
ventricular tachycardia
ventricular fibrillation

Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Nifekalant
Anti-Arrhythmia Agents