UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020221 |
|---|---|
| Receipt number | 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 04:26:09 |
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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
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
yamadas@met.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate school of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023354
| 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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