NCT07075744

Brief Summary

This retrospective observational study investigates the association between intraoperative heart rate and 30-day postoperative mortality among patients undergoing non-cardiac surgery. The findings suggest that heart rate abnormalities during surgery may significantly affect short-term postoperative outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139,149

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

July 11, 2025

Last Update Submit

July 11, 2025

Conditions

Keywords

Heart rateIntraoperativeTachycardiaBradycardiaMortality

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality within 30 days after non-cardiac surgery

    The primary outcome is defined as death from any cause occurring within 30 days after the date of surgery. Mortality data were collected from institutional electronic medical records and verified through discharge and follow-up records. The association between intraoperative heart rate metrics and postoperative mortality was retrospectively analyzed.

    30 days after the date of surgery

Study Arms (1)

Non-cardiac Surgery Cohort

This cohort includes adult patients who underwent non-cardiac surgery under general or regional anesthesia. The study retrospectively examined intraoperative heart rate patterns and their association with postoperative 30-day mortality. No intervention was applied as this is an observational study.

Other: Intraoperative Heart Rate Monitoring

Interventions

This is a non-interventional observational analysis of intraoperative heart rate metrics, including minimum, maximum, average, and time-weighted average heart rate recorded during non-cardiac surgery. The study also includes duration-based metrics such as time spent below or above specific heart rate thresholds. These variables were retrospectively analyzed for their association with 30-day postoperative mortality. No clinical intervention or treatment was administered as part of this study.

Non-cardiac Surgery Cohort

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (aged 18 years or older) who underwent non-cardiac surgery under general or regional anesthesia at a single tertiary medical center. Only the first surgery after admission was included for patients who underwent multiple procedures. Patients undergoing cardiac-related procedures, pediatric or obstetric cases, cadaveric surgeries, or those with incomplete vital signs or laboratory data were excluded.

You may qualify if:

  • Patients who underwent non-cardiac surgery at our medical center between March 2019 and February 2023
  • Age ≥ 18 years
  • Availability of complete laboratory data and perioperative vital signs
  • Only the first surgery performed after hospital admission was included for patients with multiple

You may not qualify if:

  • Cardiac-related surgical procedures
  • Pregnancy at the time of surgery
  • Age \< 18 years
  • Surgeries lasting less than 30 minutes
  • Cadaveric procedures
  • Missing or incomplete laboratory values or vital sign data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

MeSH Terms

Conditions

TachycardiaBradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 11, 2025

First Posted

July 20, 2025

Study Start

August 30, 2023

Primary Completion

December 31, 2024

Study Completion

January 20, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

The dataset used and/or analyzed during the current study is available from the corresponding author upon reasonable request.

Locations