UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047472 |
|---|---|
| Receipt number | R000054134 |
| Scientific Title | Cardiac output and cerebral oxygenation during rest and exercise in patients after cardiovascular surgery |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2023/03/19 17:32:25 |
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Basic information
Public title
Changes in cardiac output and cerebral oxygenation status at rest and during exercise in patients after cardiac surgery
Acronym
Changes in cardiac output and cerebral oxygenation status at rest and during exercise in patients after cardiac surgery
Scientific Title
Cardiac output and cerebral oxygenation during rest and exercise in patients after cardiovascular surgery
Scientific Title:Acronym
Cardiac output and cerebral oxygenation during rest and exercise in patients after cardiovascular surgery
Region
| Japan |
Condition
Condition
After Cardiovascular Surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform a cardiopulmonary exercise stress test on postoperative cardiac major vascular surgery patients and compare cerebral oxygen saturation during exercise over time in patients with a maximal oxygen pulse of less than 85% of predicted value and in patients with a maximal oxygen pulse of 85% or greater.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cerebral regional oxygen saturation at rest and during exercise
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients undergoing rehabilitation
2. patients whose physicians have decided to start weaning based on clinical criteria
3. age 20 years or older
4. patients scheduled for admission for cardiac and major vascular surgery
5. patients who meet 1-4 and have undergone cardiopulmonary exercise testing during hospitalization
Key exclusion criteria
1. NIRS probe not applicable
2. chronic ventilation disorders such as COPD, emphysema, bronchial asthma, chronic bronchitis
3. history of stroke
4. moderate to severe carotid artery stenosis
5. respiratory quotient at peak of cardiopulmonary exercise test is less than 1.1
6. after pacemaker implantation
7. patients who have requested to refuse the study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Leo |
| Middle name | |
| Last name | Washizawa |
Organization
Niigata University of Health and Welfare
Division name
master's
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4455
hpm21019@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Leo |
| Middle name | |
| Last name | Washizawa |
Organization
Niigata University of Health and Welfare
Division name
master's
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
025-257-4455
Homepage URL
hpm21019@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-257-4455
hpm21019@nuhw.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
神戸市立医療センター中央市民病院(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | 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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted as a single-arm prospective observational study.
Management information
Registered date
| 2022 | Year | 04 | Month | 12 | Day |
Last modified on
| 2023 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054134
