UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059370 |
|---|---|
| Receipt number | R000066853 |
| Scientific Title | Association Between Perioperative Hemodynamic Parameters and Delirium in Aortic Surgery Using Selective Cerebral Perfusion |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/10 17:50:11 |
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Basic information
Public title
Association Between Perioperative Hemodynamic Parameters and Delirium in Aortic Surgery Using Selective Cerebral Perfusion
Acronym
Association Between Perioperative Hemodynamic Parameters and Delirium in Aortic Surgery Using Selective Cerebral Perfusion
Scientific Title
Association Between Perioperative Hemodynamic Parameters and Delirium in Aortic Surgery Using Selective Cerebral Perfusion
Scientific Title:Acronym
Association Between Perioperative Hemodynamic Parameters and Delirium in Aortic Surgery Using Selective Cerebral Perfusion
Region
| Japan |
Condition
Condition
Aortic Disease
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Delirium is recognized as a negative prognostic factor in the perioperative period; however, investigating its association with perioperative hemodynamic parameters may contribute to improving patient outcomes. This retrospective study examined the relationship between perioperative hemodynamic parameters and the development of delirium.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association Between ICDSC Scores and Hemodynamic Parameters (Blood Pressure Variability and Central Venous Pressure)
Key secondary outcomes
Association Between the Onset of Delirium and Hemodynamic Parameters (Blood Pressure Variability and Central Venous Pressure): Relationships Among Age, Sex, BMI, Cardiopulmonary Bypass Duration, Other Hemodynamic Variables, and Delirium.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients Undergoing Aortic Surgery
Key exclusion criteria
Patients with a history of cerebral infarction accompanied by impaired consciousness prior to surgery
Patients with a history of cerebral hemorrhage accompanied by impaired consciousness prior to surgery
Patients with liver cirrhosis classified as Child-Pugh class C
Patients receiving maintenance dialysis
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Kimito |
| Middle name | |
| Last name | Minami |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Critical Care Medicine
Zip code
564-8565
Address
6-1 Kishibe-Shinmachi, Suita, Osaka , Japan
TEL
0661701070
k.minami@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Saga |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesiology
Zip code
564-8565
Address
6-1 Kishibe-Shinmachi, Suita, Osaka , Japan
TEL
09082507301
Homepage URL
saga.takashi@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
non
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
National Cerebral and Cardiovascular Center Research Ethics Committee
Address
6-1 Kishibe-Shinmachi, Suita, Osaka 564-8565, Japan
Tel
0661701070
rec-office-ac@ncvc.go.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 | 10 | Month | 14 | 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
270
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Retrospective observational study.
We investigated the association between age, sex, body mass index (BMI), cardiopulmonary bypass duration, perioperative hemodynamic parameters, and the occurrence of delirium in patients who underwent aortic surgery with selective cerebral perfusion between January 1, 2021, and September 30, 2023.
Management information
Registered date
| 2025 | Year | 10 | Month | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066853
