UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Desflurane-induced myocardial protection in cardiac surgery
Title of the study (Brief title)	Desflurane-induced myocardial protection
Region	Japan

Condition
Condition	Patients undergoing aortic valve replacement
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation for desflurane-induced myocardial protesion in patients undergoing aortic valve replacement
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	redcution in perioperative myocardial injury
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	desflurane
Interventions/Control_2	propofol
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients undergoing aortic valve replacement 2. Patients who cooperate for blood collection
Key exclusion criteria	1. Patients less than 20 years old 2. Emergency surgery 3. Pt who received coronary artery bypass surgery prior to the study 4. Patinets with history of malignant hyperthermia 5. Allergy to propofol
Target sample size	184

Research contact person
Name of lead principal investigator	Nobuyuki Katori
Organization	School of Medicine, Keio University
Division name	Department of Anesthesiology
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-3353-1211
Email	nbyk@a5.keio.jp

Public contact
Name of contact person	Nobuyuki Katori
Organization	Keio University
Division name	Department of Anesthesiology
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	nbyk@a5.keio.jp

Sponsor
Institute	School of Medicine, Keio University
Institute
Department

Funding Source
Organization	Baxter
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	United States

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	2014 Year 09 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 09 Month 03 Day
Last follow-up date	2017 Year 09 Month 01 Day
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	2014 Year 08 Month 31 Day
Last modified on	2017 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017451