UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036905 |
|---|---|
| Receipt number | R000042058 |
| Scientific Title | Correlation of postoperative delirium with oxidative stress of non-cardiac surgery |
| Date of disclosure of the study information | 2019/05/31 |
| Last modified on | 2019/05/31 01:10:04 |
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Basic information
Public title
Correlation of postoperative delirium with oxidative stress of non-cardiac surgery
Acronym
Correlation of postoperative delirium with oxidative stress of non-cardiac surgery
Scientific Title
Correlation of postoperative delirium with oxidative stress of non-cardiac surgery
Scientific Title:Acronym
Correlation of postoperative delirium with oxidative stress of non-cardiac surgery
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
non-cardiac surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery | Dermatology |
| Orthopedics | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between perioperative oxidative stress and postoperative delirium following non-cardiac surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma vitamin C concentration and postoperative delirium
Key secondary outcomes
Oxidative stress marker, inflammatory marker and biochemical exam
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
elective non-cardiovascular surgery patients
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshihide |
| Middle name | |
| Last name | Kuribayashi |
Organization
Tsurumi Hospital
Division name
Department of Anesthesiology
Zip code
874-8585
Address
4333 Tsurumi, Beppu City, Oita
TEL
0977-23-7111
kuribayashi@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihid |
| Middle name | |
| Last name | Kuribayashi |
Organization
Tsurumi Hospital
Division name
Department of Anesthesiology
Zip code
874-8585
Address
4333 Tsurumi, Beppu City, Oita
TEL
0977-23-7111
Homepage URL
kuribayashi@oita-u.ac.jp
Sponsor or person
Institute
Tsurumi Hospital
Institute
Department
Personal name
Funding Source
Organization
Oita University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsurumi Hospital
Address
4333 Tsurumi, Beppu City, Oita
Tel
0977-23-7111
kuribayashi@oita-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
| 2019 | Year | 05 | Month | 31 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Postoperative delirium (POD) affects approximately 20 - 30 % of patients after cardiovascular surgery and is associated with increased mortality and persistent cognitive decline, and the prevention of POD is a matter of the highest urgency. Patients undergoing cardiac surgery increase the production of reactive oxygen species and induce oxidative injury due to tissue hypoxia, ischemia and hyperoxic reperfusion. Therefore, intraoperative oxidative injury may contribute to postoperative brain injury and subsequent POD. We conducted this study to test the hypothesis that perioperative oxidative stress is associated with the department of POD following cardiac surgery. If the hypothesis holds true, we hope future studies to determine whether interventions that reduce oxidative stress decrease POD.
Management information
Registered date
| 2019 | Year | 05 | Month | 31 | Day |
Last modified on
| 2019 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042058
