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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010064
Receipt No. R000011770
Scientific Title A prospective study of prophylactic effect of amiodarone on reperfusion ventricular fibrillation in cardiac surgical patients with ventricular hypertrophy.
Date of disclosure of the study information 2013/02/20
Last modified on 2017/04/28

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Basic information
Public title A prospective study of prophylactic effect of amiodarone on reperfusion ventricular fibrillation in cardiac surgical patients with ventricular hypertrophy.
Acronym A prospective study of prophylactic effect of amiodarone on reperfusion ventricular fibrillation in cardiac surgical patients with ventricular hypertrophy.
Scientific Title A prospective study of prophylactic effect of amiodarone on reperfusion ventricular fibrillation in cardiac surgical patients with ventricular hypertrophy.
Scientific Title:Acronym A prospective study of prophylactic effect of amiodarone on reperfusion ventricular fibrillation in cardiac surgical patients with ventricular hypertrophy.
Region
Japan

Condition
Condition Patients with ventricular hypertrophy undergoing elective cardiac surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate whether administration of amiodarone can reduce the incidence rate of reperfusion ventricular fibrillation as compared to lidocaine administration in patients with left ventricular hypertrophy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incidence rate of reperfusion ventricular fibrillation after release of aortic cross clamp.
Key secondary outcomes The use of direct current shock,energy of direct current shock.
The incidence rate of intraoperative and postoperative pacemaker use,postoperative arterial fibrillation.
The incidence rate of postoperative pulmonary, thyroidal, and hepatic dysfunction.
Ventilator time, intensive care unit stay, hospital stay, 30 day mortality.
Laboratory data.
perioperative hemodynamic data.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Amiodarone group
150mg of amiodarone is administerd over 10 minutes followed by continuous infusion of amiodarone at the rate of 30mg/hr.
Interventions/Control_2 Lidocaine group
1mg/kg of lidocaine is administered followed by continuous infusion of lidocaine at the rate of 1mg/kg/hr
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing elective aortic valve replacement for severe aortic stenosis.
Key exclusion criteria Patients with ejection fraction of less than 40%, bundle branch block, QT prolongation,atrial fibrillation, pacemaker use, coronary artery disease.
Patients with liver dysfunction, thyroid dysfunction, interstitial pneumonitis.
Patients with renal dysfunction with creatinine >1.5mg/dl or creatinine clearance < 30ml/min, or hemodialysis treatment.
Patients allergic to amiodarone or lidocaine.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norikatsu Mita
Organization Saitama cardiovascular and respiratory center
Division name Anesthesiology
Zip code
Address 1696 Itai, kumagaya, Saitama Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Saitama cardiovascular and respiratory center
Division name Anesthesiology
Zip code
Address
TEL 048-536-9900
Homepage URL
Email

Sponsor
Institute Saitama cardiovascular and respiratory center
Institute
Department

Funding Source
Organization Saitama cardiovascular and respiratory center
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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
2013 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Open public recruiting
Date of protocol fixation
2011 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 18 Day
Last modified on
2017 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011770

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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