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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004699
Receipt No. R000005594
Scientific Title Elucidation of the mechanisms underlying cardioprotection by long-acting and ultrrashort-acting beta blockers in cardiac surgery
Date of disclosure of the study information 2010/12/15
Last modified on 2013/06/14

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Basic information
Public title Elucidation of the mechanisms underlying cardioprotection by long-acting and ultrrashort-acting beta blockers in cardiac surgery
Acronym The role of beta-blocker on cardiac surgery
Scientific Title Elucidation of the mechanisms underlying cardioprotection by long-acting and ultrrashort-acting beta blockers in cardiac surgery
Scientific Title:Acronym The role of beta-blocker on cardiac surgery
Region
Japan

Condition
Condition patients undergoing cardiac bypass surgery
Classification by specialty
Anesthesiology Cardiovascular surgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to validate the potential of beta-blocker to protect cardiac muscle cell damage in cardiac bypass surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Plasma fatty acid binding protein, and brain natriuretic peptide concentration was measured during the perioperative period of cardiac bypass surgery.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 beta-blocker
Interventions/Control_2 non beta-blocker
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing cardiac bypass surgery
Patients undergoing valve plasty and valve replacement
Key exclusion criteria Sever Liver Disease, Muscle Disease
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasufumi Nakajima
Organization Kyoto Prefectural University of Medicine
Division name Department of Anesthesiology
Zip code
Address Kawarmachi Hirokoji, Kamigyo, Kyoto, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto Prefectural University of Medicine
Division name Department of Anesthesiology
Zip code
Address
TEL 075-251-5633
Homepage URL
Email

Sponsor
Institute Department of Anesthesiology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Other
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
2010 Year 12 Month 15 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 Enrolling by invitation
Date of protocol fixation
2010 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 15 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
2010 Year 12 Month 09 Day
Last modified on
2013 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005594

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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