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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001781
Receipt No. 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

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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
Email 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
Email mshiga@hij.twmu.ac.jp

Sponsor
Institute Japan Medical Promotion Agency
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002143

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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