UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056467 |
|---|---|
| Receipt number | R000064514 |
| Scientific Title | Randomized Controlled Trial on the Efficacy of the Hypotension Prediction Index in Preventing Intraoperative Hypotension and Its Relationship with Myocardial Injury after Non-Cardiac Surgery |
| Date of disclosure of the study information | 2025/04/07 |
| Last modified on | 2025/12/17 16:53:31 |
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Basic information
Public title
Study on the Efficacy of the Hypotension Prediction Index in Preventing Intraoperative Hypotension and Its Relationship with Myocardial Injury
Acronym
Hypotension Prevention using the HPI and its Relationship with Myocardial Injury
Scientific Title
Randomized Controlled Trial on the Efficacy of the Hypotension Prediction Index in Preventing Intraoperative Hypotension and Its Relationship with Myocardial Injury after Non-Cardiac Surgery
Scientific Title:Acronym
HPI-IOH and MINS Trial
Region
| Japan |
Condition
Condition
Intraoperative Hypotension
Classification by specialty
| Cardiology | Surgery in general | Anesthesiology |
| Operative medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether anesthesia management using the Hypotension Prediction Index (HPI) reduces the proportion of intraoperative hypotension duration relative to the total anesthesia time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of intraoperative hypotension duration relative to the total anesthesia time in the ABP group (using the FloTrac sensor) and the HPI group (using the Acumen IQ sensor).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
ABP group: Anesthesia management is performed using Flotrac sensor and Hemosphere Advanced Monitoring Platform, and management guidelines are left to the anesthesiologist.
Interventions/Control_2
HPI group: Anesthesia management will be performed using the Acumen IQ sensor and Hemosphere Advanced Monitoring Platform, following the intervention protocol for the HPI group, with the goal of maintaining a mean arterial pressure of 65 mmHg.
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing scheduled surgery
2) Non-cardiac surgery patients
3) Patients over 45 years old
4) Patients scheduled to be admitted to the intensive care unit (ICU) after surgery
5) Patients who are scheduled to undergo surgery that is normally managed by inserting an arterial catheter.
Key exclusion criteria
1) Patients undergoing surgery that require extracorporeal circulation for intraoperative and postoperative management
2) Patients who are scheduled to undergo multiple surgeries during the target period
3) Patients expected to be discharged by the second postoperative day
4) Patients who cannot insert an arterial catheter into the radial artery
5) Patients with severe heart valve disease and arrhythmia
6) Patients undergoing surgery where the surgeon has restrictions on fluid and blood transfusion management during intraoperative management.
7) Patients undergoing surgery that require low blood pressure control during intraoperative management
8) Other patients deemed unsuitable by the attending physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Tobe |
Organization
Gunma University Hospital
Division name
Intensive Care Unit
Zip code
371-8511
Address
3-39-15 Showa-cho, Maebashi City, Gunma Prefecture
TEL
027-220-8698
mtobe@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sasaki |
Organization
Gunma University Hospital
Division name
Intensive Care Unit
Zip code
371-8511
Address
3-39-15 Showa-cho, Maebashi City, Gunma Prefecture
TEL
027-220-8698
Homepage URL
yskssk7@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
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
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-cho, Maebashi City, Gunma Prefecture
Tel
027-220-7111
gunma-u@esct.bvits.com
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 | 04 | Month | 07 | 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
| 2024 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064514
