UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037302 |
|---|---|
| Receipt number | R000042531 |
| Scientific Title | The incidence of postoperative cognitive dysfunction of the elderly patients and the analysis of risk factors. |
| Date of disclosure of the study information | 2020/01/29 |
| Last modified on | 2020/09/23 18:15:11 |
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Basic information
Public title
The incidence of postoperative cognitive dysfunction of the elderly patients and the analysis of risk factors.
Acronym
The incidence of postoperative cognitive dysfunction of the elderly patients and the analysis of risk factors.
Scientific Title
The incidence of postoperative cognitive dysfunction of the elderly patients and the analysis of risk factors.
Scientific Title:Acronym
The incidence of postoperative cognitive dysfunction of the elderly patients and the analysis of risk factors.
Region
| Japan |
Condition
Condition
postoperative cognitive dysfunction
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of screening method and anesthesia management method for high risk patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The independent risk factors of early postoperative cognitive dysfunction of the elderly patients
Key secondary outcomes
The incidence of early postoperative cognitive dysfunction of the elderly patients
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
| 75 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
75 years-old or older
Key exclusion criteria
Preoperative cognitive dysfunction
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamashita |
Organization
Kobe city medical center general hospital
Division name
department of anesthesiology
Zip code
650047
Address
Chuouku Minatojimaminamichou2-1-1,Kobe
TEL
0783024321
cantateveritas@ae.auone-net.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yamashita |
Organization
Kobe city medical center general hospital
Division name
department of anesthesiology
Zip code
650047
Address
Chuouku Minatojimaminamichou2-1-1,Kobe
TEL
0783024321
Homepage URL
cantateveritas@ae.auone-net.jp
Sponsor or person
Institute
Kobe city medical center general hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Not Applicable
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe city medical center general hospital
Address
Chuouku Minatojimaminamichou2-1-1,Kobe
Tel
0783024321
cantateveritas@ae.auone-net.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 | 01 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
303
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
Main results already published
Date of protocol fixation
| 2019 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The incidence of postoperative cognitive dysfunction of the elderly patients and the multivariate analysis of risk factors.
Management information
Registered date
| 2019 | Year | 07 | Month | 08 | Day |
Last modified on
| 2020 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042531
