UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of prophylactic effect of amiodarone on reperfusion ventricular fibrillation in cardiac surgical patients with ventricular hypertrophy.
Title of the study (Brief title)	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	Norikatsu Mita
Organization	Saitama cardiovascular and respiratory center
Division name	Anesthesiology
Address	1696 Itai, kumagaya, Saitama Japan
TEL
Email

Public contact
Name of contact person
Organization	Saitama cardiovascular and respiratory center
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 07 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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