UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058253 |
|---|---|
| Receipt number | R000066010 |
| Scientific Title | Association Between Intraoperative Blood Pressure Variability and Postoperative Delirium after Hepatectomy: A Retrospective Observational Study |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/23 11:44:42 |
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Basic information
Public title
Association Between Intraoperative Blood Pressure Variability and Postoperative Delirium after Hepatectomy: A Retrospective Observational Study
Acronym
Blood Pressure Variability and Delirium after Hepatectomy
Scientific Title
Association Between Intraoperative Blood Pressure Variability and Postoperative Delirium after Hepatectomy: A Retrospective Observational Study
Scientific Title:Acronym
Blood Pressure Variability and Delirium after Hepatectomy
Region
| Japan |
Condition
Condition
Hepatic resection
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether intraoperative blood pressure variability, assessed using invasive arterial blood pressure monitoring, is associated with the occurrence of postoperative delirium within seven days after surgery in patients who underwent hepatic resection at our institution between May 2021 and March 2025.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative delirium within seven days
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who underwent hepatic resection at our institution between May 2021 and March 2025.
2.Patients aged 20 years or older at the time of surgery.
Key exclusion criteria
1.Patients who underwent emergency surgery.
2.Patients in whom invasive arterial blood pressure monitoring was not performed during surgery.
Target sample size
490
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Juri |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abenoku, Osaka City, Osaka, Japan
TEL
0666452186
takataka0061@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Juri |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abenoku, Osaka City, Osaka, Japan
TEL
0666452186
Homepage URL
takataka0061@yahoo.co.jp
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-founding
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
Osaka Metropolitan University Graduate School of Medicine Ethics committee
Address
1-5-7,Asahimachi, Abenoku, Osaka City, Osaka, Japan
Tel
0666456125
ethics@med.osaka-cu.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
| 2025 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to investigate whether intraoperative blood pressure variability, assessed using invasive arterial blood pressure monitoring, is associated with the occurrence of postoperative delirium within seven days after surgery in patients who underwent hepatic resection at our institution between May 2021 and March 2025.
Management information
Registered date
| 2025 | Year | 06 | Month | 23 | Day |
Last modified on
| 2025 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066010
