UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049927 |
|---|---|
| Receipt number | R000056466 |
| Scientific Title | Prospective study on impact of body composition analysis by InBodyS10 on perioperative management of cardiovascular surgery |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2024/06/29 18:44:03 |
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Basic information
Public title
Body composition analysis by InBodyS10 and perioperative management of cardiovascular surgery
Acronym
Body composition analysis by InBodyS10 and perioperative management of cardiovascular surgery
Scientific Title
Prospective study on impact of body composition analysis by InBodyS10 on perioperative management of cardiovascular surgery
Scientific Title:Acronym
Body composition analysis by InBodyS10 and perioperative management of cardiovascular surgery
Region
| Japan |
Condition
Condition
cardiovascular disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate usefulness of body composition analysis by InBodyS10 for perioperative management
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To estimate the impact of change in preoperative and postoperative body composition on clinical outcomes including weaning from respiratory support machine and/or diuretic agent administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Body composition analysis by InBodyS10
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of or over 18 years who are to receive cardiovascular surgeries
when themselves or proxy can give consent
Key exclusion criteria
Age under 18
patients unable to give consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kan |
| Middle name | |
| Last name | Nawata |
Organization
St Marianna University School of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
2168511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
knawata.cvs@gmail.com
Public contact
Name of contact person
| 1st name | Kan |
| Middle name | |
| Last name | Nawata |
Organization
St Marianna University School of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
2168511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
knawata.cvs@gmail.com
Sponsor or person
Institute
St Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St Marianna University School 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
St Marianna University School of Medicine IRB
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
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
| 2023 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056466
