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

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 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


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

Value
https://center6.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