UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015004 |
|---|---|
| Receipt number | R000017451 |
| Scientific Title | Desflurane-induced myocardial protection in cardiac surgery |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2017/09/07 10:38:22 |
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Basic information
Public title
Desflurane-induced myocardial protection in cardiac surgery
Acronym
Desflurane-induced myocardial protection
Scientific Title
Desflurane-induced myocardial protection in cardiac surgery
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Katori |
Organization
School of Medicine, Keio University
Division name
Department of Anesthesiology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
nbyk@a5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Katori |
Organization
Keio University
Division name
Department of Anesthesiology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
Homepage URL
nbyk@a5.keio.jp
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
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)
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
| 2014 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017451
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
