UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062563 |
|---|---|
| Receipt number | R000071614 |
| Scientific Title | Effect Modification of the Association Between Intraoperative Hypotension Burden and Postoperative Acute Kidney Injury by AI-Derived Indices from Preoperative 12-Lead Electrocardiograms: A Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/08/14 |
| Last modified on | 2026/08/12 16:20:03 |
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Basic information
Public title
Effect Modification of the Association Between Intraoperative Hypotension Burden and Postoperative Acute Kidney Injury by AI-Derived Indices from Preoperative 12-Lead Electrocardiograms: A Retrospective Cohort Study
Acronym
ECG-AI MAP-AKI Susceptibility Study
Scientific Title
Effect Modification of the Association Between Intraoperative Hypotension Burden and Postoperative Acute Kidney Injury by AI-Derived Indices from Preoperative 12-Lead Electrocardiograms: A Retrospective Cohort Study
Scientific Title:Acronym
ECG-AI MAP-AKI Susceptibility Study
Region
| Japan |
Condition
Condition
Surgical cases managed by the Department of Anesthesiology
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate whether the association between intraoperative mean arterial pressure (MAP) reduction and postoperative acute kidney injury is modified by a preoperative 12-lead ECG AI index-derived by inputting raw waveform data from standard preoperative 12-lead ECGs into PreOpNet, a publicly available pre-trained AI model.
Basic objectives2
Others
Basic objectives -Others
Assessment of effect modification by preoperative 12-lead ECG AI indices on the association between intraoperative hypotension burden and postoperative acute kidney injury
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative acute kidney injury (AKI) according to the serum creatinine-based KDIGO criteria. Baseline creatinine is the most recent valid value within 60 days before the start of anesthesia. The postoperative assessment window extends from the end of anesthesia until the earliest of 7 days after anesthesia, hospital discharge, death, or the start of the next anesthetic. Urine-output criteria are not used.
Key secondary outcomes
Severe AKI (KDIGO stage 2 or 3), postoperative renal replacement therapy, and a composite of AKI or death during the same postoperative assessment window.
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
1. Patients who underwent surgery managed by the Department of Anesthesiology at Shimane University Hospital between April 2016 and March 2026.
2. Age 18 years or older.
3. Intraoperative mean arterial pressure time-series data are available from the start to the end of anesthesia.
4. At least one serum creatinine measurement is available within 60 days before the start of anesthesia.
5. Raw preoperative 12-lead ECG waveform data are available in a research-compatible format.
Key exclusion criteria
1. End-stage kidney disease or preoperative acute kidney injury.
2. Cardiac surgery, surgery using cardiopulmonary bypass, or transplantation.
3. Use of a circulatory support device such as IABP, ECMO, or Impella.
4. Endovascular or gastrointestinal endoscopic procedures, sedation for diagnostic procedures, or other procedures with invasiveness substantially different from major surgery.
5. Cases in which the primary ECG-AI index, MAP65_AUT, or postoperative AKI cannot be appropriately derived because of inadequate ECG, intraoperative blood pressure, creatinine, timing, or record-linkage data.
6. Patients who opted out of research use.
7. Second or subsequent surgery/anesthesia in the same patient during the study period.
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Terumasa |
| Middle name | |
| Last name | Matsuo |
Organization
Shimane University Hospital
Division name
Department of Anesthesiology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2295
tmatsuo@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Terumasa |
| Middle name | |
| Last name | Matsuo |
Organization
Shimane University Hospital
Division name
Department of Anesthesiology
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2295
Homepage URL
tmatsuo@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Terumasa Matsuo
Funding Source
Organization
Shimane University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
Tel
0853-20-2515
kenkyu@med.shimane-u.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
島根大学医学部附属病院 麻酔科 / Department of Anesthesiology, Shimane University Hospital
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | 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
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
Yes (potentially after publication of the study results).
IPD sharing Plan description
After publication of the study results, de-identified individual participant data may be shared with other institutions after review of the research purpose, analysis plan, and ethical appropriateness. The principal investigator will determine whether, what, and how data may be shared for each request.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 23 | Day |
Date of closure to data entry
| 2030 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a retrospective observational study using data already collected between April 2016 and March 2026. In accordance with the UMIN-CTR data-entry convention for retrospective studies, the anticipated trial start date and the last follow-up date are entered as the protocol fixation date for convenience.
Management information
Registered date
| 2026 | Year | 08 | Month | 12 | Day |
Last modified on
| 2026 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071614
