UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042104 |
|---|---|
| Receipt number | R000048051 |
| Scientific Title | Study on the relationship between postoperative delirium and blood ascorbic acid levels in patients undergoing cardiovascular surgery |
| Date of disclosure of the study information | 2020/10/13 |
| Last modified on | 2023/07/14 00:30:08 |
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Basic information
Public title
Study on the relationship between postoperative delirium and blood ascorbic acid levels in patients undergoing cardiovascular surgery
Acronym
Study on the relationship between postoperative delirium and blood ascorbic acid levels in patients undergoing cardiovascular surgery
Scientific Title
Study on the relationship between postoperative delirium and blood ascorbic acid levels in patients undergoing cardiovascular surgery
Scientific Title:Acronym
Study on the relationship between postoperative delirium and blood ascorbic acid levels in patients undergoing cardiovascular surgery
Region
| Japan |
Condition
Condition
postoperative delirium
Classification by specialty
| Cardiovascular surgery | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether preoperative and postoperative ascorbic acid blood levels are associated with the development of postoperative delirium in patients undergoing cardiovascular surgery using cardiopulmonary bypass.
Basic objectives2
Others
Basic objectives -Others
To examine whether preoperative and postoperative ascorbic acid blood levels are associated with the development of postoperative delirium in patients undergoing cardiovascular surgery using cardiopulmonary bypass.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
development of postoperative delirium
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
elective cardiovascular surgery using cardiopulmonary bypass
Key exclusion criteria
dementia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Iizuka |
Organization
Saitama medical center, jichi university
Division name
department of critical care and anesthesiology
Zip code
3308503
Address
1-847 Amanuma town, Omiya Ku, Saitama City, Saitama
TEL
0486472111
yiizuka@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Iizuka |
Organization
Saitama medical center, jichi university
Division name
department of critical care and anesthesiology
Zip code
3308503
Address
1-847 Amanuma town, Omiya Ku, Saitama City, Saitama
TEL
0486472111
Homepage URL
yiizuka@jichi.ac.jp
Sponsor or person
Institute
jichi university
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
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
Saitama medical center, jichi university
Address
1-847 Amanuma town, Omiya Ku, Saitama City, Saitama
Tel
0486472111
yiizuka@jichi.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
| 2020 | Year | 10 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2308-3425/10/7/293
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2308-3425/10/7/293
Number of participants that the trial has enrolled
100
Results
We enrolled 100 patients, and the data of 98 patients were analyzed. Results: In total, 31 patients developed delirium, while 67 did not. Preoperative plasma ascorbic acid levels did not differ between the non-delirium and delirium groups. Postoperative plasma ascorbic acid levels were significantly different between the groups. Conclusion: In patients who undergo cardiovascular surgery with CPB, lower postoperative plasma ascorbic acid levels may be associated with the development of delirium.
Results date posted
| 2023 | Year | 07 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients older than 70 years of age scheduled for elective cardiovascular surgery using cardiopulmonary bypass.
Participant flow
Written informed consent was obtained from all patients.
Adverse events
none
Outcome measures
The incidence of postoperative delirium.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the association between blood ascorbic acid levels and the development of delirium before and 24 hours after surgery.
Management information
Registered date
| 2020 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048051
