UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047693 |
|---|---|
| Receipt number | R000045410 |
| Scientific Title | The effect of postoperative delirium on a cardiopulmonary exercise testing at dischage in aged patinets undergoing cardiac surgery |
| Date of disclosure of the study information | 2022/05/09 |
| Last modified on | 2022/11/11 23:04:42 |
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Basic information
Public title
The effect of postoperative delirium on a cardiopulmonary exercise testing at dischage in aged patinets undergoing cardiac surgery
Acronym
The effect of postoperative delirium on a cardiopulmonary exercise testing
Scientific Title
The effect of postoperative delirium on a cardiopulmonary exercise testing at dischage in aged patinets undergoing cardiac surgery
Scientific Title:Acronym
The effect of postoperative delirium on a cardiopulmonary exercise testing
Region
| Japan |
Condition
Condition
Aged patients undergoing cardiac surgery
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of delirium on cardiopulmonary exercise testing at discharge
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AT-VO2 VE/VCO2 slope
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 70 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
cardiac surgical patients
Key exclusion criteria
patients who did not dischage
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Shimomoto |
Organization
Sakurabashi-Watanabe Hospital
Division name
Rehabilitation
Zip code
530-0001
Address
2-4-32 Umeda Kita-ku, Osaka , Japan
TEL
06-6341-8651
fa-7y.28_5a.15@outlook.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Shimomoto |
Organization
Sakurabashi-Watanabe Hospital
Division name
Rehabilitation
Zip code
530-0001
Address
2-4-32 Umeda Kita-ku Osaka, Japan
TEL
06-6341-8651
Homepage URL
fa-7y.28_5a.15@outlook.jp
Sponsor or person
Institute
Sakurabashi-Watanabe Hospital
Institute
Department
Personal name
Funding Source
Organization
Sakurabashi-Watanabe Hospital
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
Sakurabashi-Watanabe Hospital IRB
Address
2-4-32 Umeda Kita-ku Osaka, Japan
Tel
06-6341-8651
i_oka@watanabe-hsp.or.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
| 2022 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
http://www.watanabe-hsp.or.jp/hospitalinfo/optout
Publication of results
Unpublished
Result
URL related to results and publications
https://www.meeting-schedule.com/jsicm47/author.html
Number of participants that the trial has enrolled
70
Results
AT-VO2 and the slope of VCO2 and VE in the presence and absence of delirium and both values were comparable between the groups.
Results date posted
| 2022 | Year | 05 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Seventy patients aged 70 or older undergoing cardiac valve surgery, entered our ICU and were discharged from our hospital between June 2016 and July 2018.
Participant flow
All patients received active exercise from our rehabilitation team since the first postoperative day while on mechanical ventilation, and performed a CPX on a cycle ergometer before discharge.
Adverse events
No problem
Outcome measures
AT-VO2 VE/VCO2slope
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 05 | Month | 09 | Day |
Last modified on
| 2022 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045410
