Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062563) titled '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' on Aug. 14.

Study Type: Observational

Primary Sponsor: Institute - Shimane University

Condition: Condition - Surgical cases managed by the Department of Anesthesiology Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 20000

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071614

Disclaimer: Curated by HT Syndication.