UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010064 |
|---|---|
| Receipt number | 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 12:47:35 |
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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
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
Sponsor or person
Institute
Saitama cardiovascular and respiratory center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011770
