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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020221
Receipt No. R000023354
Scientific Title Feasibility and effectiveness of electrical stimulation as countermeasure against muscle proteolysis after cardiovascular surgery
Date of disclosure of the study information 2015/12/16
Last modified on 2015/12/24

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Basic information
Public title Feasibility and effectiveness of electrical stimulation as countermeasure against muscle proteolysis after cardiovascular surgery
Acronym Feasibility and effectiveness of electrical stimulation as countermeasure against muscle proteolysis after cardiovascular surgery
Scientific Title Feasibility and effectiveness of electrical stimulation as countermeasure against muscle proteolysis after cardiovascular surgery
Scientific Title:Acronym Feasibility and effectiveness of electrical stimulation as countermeasure against muscle proteolysis after cardiovascular surgery
Region
Japan

Condition
Condition Adult patients who were intended for elective major cardiovascular surgery (coronary artery bypass surgery, valvular surgery, aortic surgery, or combined surgery)
Classification by specialty
Cardiovascular surgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the feasibility and effectiveness of postoperative electrical stimulation as countermeasure against muscle proteolysis after cardiovascular surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the concentration of 3-MH in 24 hours urine corrected for urinary creatinine content from postoperative day 1 to 5
Key secondary outcomes knee extensor isometric strength
handgrip strength

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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
Device,equipment
Interventions/Control_1 Electrical muscle stimulation and postoperative mobilization program
Electrical muscle stimulation: implemented on bilateral quadriceps and triceps surae muscles for 30-60 minutes daily from postoperative day 1 to 5
Interventions/Control_2 postoperative mobilization program
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 aged 20 and over
2. Patients who were intended for elective major cardiovascular surgery
Key exclusion criteria 1. Patients with chronic renal failure
2. Patients with peripheral arterial disease
3. Patients with a previous history of psychiatric disease
4. Patients with a previous history of neuromuscular disease
5. Patinets with cognitive impairment before surgery (Mini-Mental State Examination <18 points)
6. Patients with intubation beyond 24h after surgery
7. Patients who received reoperation
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name YAMADA SUMIO
Organization Nagoya University
Division name Graduate school of Medicine
Zip code
Address 1-1-20 Daiko-minami Higashi-ku Nagoya 461-8673, Japan
TEL 052-719-1349
Email yamadas@met.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name YAMADA SUMIO
Organization Nagoya University
Division name Graduate school of Medicine
Zip code
Address 1-1-20 Daiko-minami Higashi-ku Nagoya 461-8673, Japan
TEL 052-719-1349
Homepage URL
Email yamadas@met.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate school of Medicine
Institute
Department

Funding Source
Organization the Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
2015 Year 12 Month 16 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 Completed
Date of protocol fixation
2011 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 23 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
2015 Year 12 Month 16 Day
Last modified on
2015 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023354

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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