UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010329 |
|---|---|
| Receipt number | R000012089 |
| Scientific Title | Usefulness of pNF-H as a biomarker for post-operative delirium |
| Date of disclosure of the study information | 2013/03/27 |
| Last modified on | 2023/04/04 12:09:38 |
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Basic information
Public title
Usefulness of pNF-H as a biomarker for post-operative delirium
Acronym
Biomarker for post-operative delirium
Scientific Title
Usefulness of pNF-H as a biomarker for post-operative delirium
Scientific Title:Acronym
Biomarker for post-operative delirium
Region
| Japan |
Condition
Condition
Patients receiving a surgery except for brain and spinal surgeries
Classification by specialty
| Surgery in general | Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm usefulnee of pNF-H as a biomarker for postoperative delirium
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
serum pNF-H value
Key secondary outcomes
delirium severity score, evaluated by the NCAM-ICU
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
According to the NCAM-ICU, patients diagnosed as delirium following to surgery
Key exclusion criteria
patients who received brain and/or spinal surgeries
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sumitani |
Organization
The University of Tokyo Hospital
Division name
Department of Pain and Palliative Medicine
Zip code
113-0033
Address
Hongo 7-3-1, Bunkyo, Tokyo, 113-0033 Japan
TEL
03-3815-5411
sumitanim-ane@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Sumitani |
Organization
The University of Tokyo Hospital
Division name
Department of Pain and Palliative Medicine
Zip code
113-0033
Address
Hongo 7-3-1, Bunkyo, Tokyo, 113-0033 Japan
TEL
03-3815-5411
Homepage URL
sumitaim-ane@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
Hongo 7-3-1, Bunkyo, Tokyo, Japan
Tel
03-3815-5411
sumitanim-ane@h.u-tokyo.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
東京大学医学部附属病院（東京都）
さいたま赤十字病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 27 | 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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
pNF-H
NCAM-ICU
Management information
Registered date
| 2013 | Year | 03 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012089
