UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058155 |
|---|---|
| Receipt number | R000066475 |
| Scientific Title | Determination of Heart Rate Cutoff Values and Elucidation of the Interaction Between Heart Rate and Blood Pressure During Anesthesia |
| Date of disclosure of the study information | 2025/06/12 |
| Last modified on | 2025/06/12 10:19:52 |
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Basic information
Public title
Determination of Heart Rate Cutoff Values and Elucidation of the Interaction Between Heart Rate and Blood Pressure During Anesthesia
Acronym
Determination of Heart Rate Cutoff Values and Elucidation of the Interaction Between Heart Rate and Blood Pressure During Anesthesia
Scientific Title
Determination of Heart Rate Cutoff Values and Elucidation of the Interaction Between Heart Rate and Blood Pressure During Anesthesia
Scientific Title:Acronym
Determination of Heart Rate Cutoff Values and Elucidation of the Interaction Between Heart Rate and Blood Pressure During Anesthesia
Region
| Japan |
Condition
Condition
Tachycardia, bradycardia, hypertension, and hypotension
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the following two objectives using the perioperative dataset from the University of Tsukuba Hospital:
To clarify the association between intraoperative heart rate and patient outcomes, and to identify cutoff values for bradycardia and tachycardia. (Objective 1)
To investigate whether intraoperative heart rate modifies the relationship between intraoperative hypotension and patient outcomes. (Objective 2)
While intraoperative hypotension has been suggested to adversely affect patient outcomes, prompting anesthesiologists to manage blood pressure more rigorously, bradycardia is often overlooked. As a result, current circulatory management during anesthesia may have become unbalanced due to the growing body of evidence focusing primarily on blood pressure. If this study reveals appropriate heart rate management targets or clarifies how heart rate influences the effects of hypotension, it could fundamentally change current assumptions regarding the selection of vasopressors during surgery.
Basic objectives2
Others
Basic objectives -Others
To clarify the association between intraoperative heart rate and patient outcomes, and to identify cutoff values for bradycardia and tachycardia. (Objective 1)
To investigate whether intraoperative heart rate modifies the relationship between intraoperative hypotension and patient outcomes. (Objective 2)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of major postoperative complications (defined as any of the following: death, cardiovascular complications, or acute kidney injury)
Key secondary outcomes
>Postoperative mortality
>Occurrence of cardiovascular complications (e.g., myocardial infarction, stroke, etc.)
>Acute kidney injury
>Length of hospital stay
As this is an exploratory study, other clinically important complications will also be examined and evaluated as appropriate.
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
Patients who underwent surgery under general anesthesia at the University of Tsukuba Hospital between April 1, 2012, and March 31, 2023.
If a patient underwent multiple surgeries during a single hospitalization, only the first surgery will be included in the analysis.
Key exclusion criteria
Patients with errors or missing values in key data (e.g., age, sex, BMI, ASA-PS, etc.)
Target sample size
50000
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Shimada |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan
TEL
+81-29-853-3914
kensukeshimada@gwe.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Shimada |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan
TEL
+81-29-853-3914
Homepage URL
kensukeshimada@gwe.md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
Tel
+81-29-853-3914
kensukeshimada@gwe.md.tsukuba.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 | 06 | Month | 12 | 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 | 24 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses the dataset created by the "Large-scale observational study on the quality of perioperative care using perioperative dataset from the University of Tsukuba Hospital (R03-068)".
Management information
Registered date
| 2025 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066475
