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Heart Rate Variability Changes and Postoperative Delirium After Major Abdominal Surgery

Study acronym: HRVPOD
StatusRecruiting
PhaseNot specified
Started2026-09-21
View on ClinicalTrials.gov ↗

Amendment history

2026-09-29
notable
Recruitment opened
Trial started: 2026-09-21 (last estimated 2026-09-01)
2026-08-28
minor
Study Identification, Study Status v2
Re-verified, no change to tracked fields
2026-08-25
minor
Study Status, Outcome Measures v1
Secondary endpointsdetails revised at 3 of 4 entries
2026-08-18
minor
Original filing
This prospective observational cohort study aims to investigate whether early postoperative changes in heart rate variability (HRV) relative to baseline are associated with the development of postoperative delirium (POD) in older patients undergoing elective major abdominal surgery under general anesthesia. Patients aged 65-85 years will be enrolled. Resting HRV will be measured at 10:00 AM on the day of surgery before anesthesia induction and at the same time point on the first postoperative day using a validated heart rate monitoring device. HRV parameters will be derived from standardized 5-minute recordings. Changes in HRV parameters from baseline will be calculated, and their associations with POD occurrence will be evaluated. Postoperative delirium will be assessed daily from 24 hours after surgery to postoperative day 7, using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). The study will also explore the potential utility of HRV-derived markers for early POD risk stratification. Approximately 500 participants will be enrolled.
Trial Details
NCT Number NCT07783464
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions Postoperative Delirium (POD), Heart Rate Variability (HRV)
Enrollment 500 participants
Start Date 2026-09-21
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-09-28