UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001781 |
|---|---|
| Receipt number | R000002143 |
| Scientific Title | Refractory VT/VF, Prospective Evaluation to Differentiate Lidocaine Efficacy from Nifekalant |
| Date of disclosure of the study information | 2009/03/18 |
| Last modified on | 2016/08/05 22:18:38 |
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Basic information
Public title
Refractory VT/VF, Prospective Evaluation to Differentiate Lidocaine Efficacy from Nifekalant
Acronym
RELIEF Study
Scientific Title
Refractory VT/VF, Prospective Evaluation to Differentiate Lidocaine Efficacy from Nifekalant
Scientific Title:Acronym
RELIEF Study
Region
| Japan |
Condition
Condition
Ventricular tachycardia, Ventricular fibrillation
Classification by specialty
| Cardiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the efficacy and safety of nifekalant and lidocaine in patients with shock-resistant in-hospital VF/VT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Termination of VT/VF with/without shock
Key secondary outcomes
Return of spontaneous circulation, One-month survival, Discharge alive from the hospital,
Adverse events: asystole,pulseless electrical activity, Torsades de pointes, QT prolongation(>0.55)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In-hospital sustained VT/VF resistant to at least 2 shocks
Key exclusion criteria
Drug-induced long QT syndrome
Congenital long QT syndrome
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kasanuki |
Organization
Waseda University
Division name
Science and Engineering
Zip code
Address
1-7 Koji-machi, Chiyoda-ku, Tokyo 102-0083 Japan
TEL
03-5216-3001
hkasanuki@jheart.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Shiga |
Organization
Tokyo Women's Medical University
Division name
Cardiology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
Homepage URL
mshiga@hij.twmu.ac.jp
Sponsor or person
Institute
Japan Medical Promotion Agency
Institute
Department
Personal name
Funding Source
Organization
Japan Research Promotion Society for Cardiovascular Disease
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0300957209005036
Number of participants that the trial has enrolled
Results
After treatment of nifekalant, 23 of 27 patients showed termination of VF/VT, as compared with 15 of 28 patients treated with lidocaine (P=0.03) with/without additional shock.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 02 | Month | 01 | Day |
Other
Other related information
In total, 55 patients were enrolled. After treatment of nifekalant, 22 of 27 patients showed termination of VF/VT, as compared with 15 of 28 patients treated with lidocaine (P=0.03) with/without additional shock. 23 of 27 patients with nifekalant showed return of spontanous circulation, as compared with 15 of 28 patients with lidocaine (P=0.01). There was a higher incidence of asystole and pulseless electrical activity with lidocaine (7 of 28 patients) than with nifekalant (0 of 27 patients) (P=0.005).
Management information
Registered date
| 2009 | Year | 03 | Month | 17 | Day |
Last modified on
| 2016 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002143
