HEART RATENCT07075744
Intraoperative Heart Rate Thresholds and Postoperative Mortality
An observational study of HEART RATE, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HEART RATE
- What is being tested?
- Intraoperative Heart Rate Monitoring
- How many people
- 139,149 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2023to 20 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Intraoperative Heart Rate and Postoperative 30-day Mortality in Non-cardiac Surgery
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.
Read the detailed description
This is a retrospective cohort study conducted to evaluate the clinical impact of intraoperative heart rate on postoperative 30-day mortality in patients undergoing non-cardiac surgery. Patient data were extracted from a large institutional electronic medical record database, including demographic variables, comorbidities, anesthesia records, and perioperative outcomes.
Heart rate was continuously recorded at 1-minute or 5-minute intervals during the surgery. Various heart rate parameters-such as minimum, maximum, average, and time-weighted average-were analyzed, and threshold-based metrics (e.g., minutes spent below or above defined thresholds) were computed using a piecewise cubic Hermite interpolating polynomial (PCHIP) method to smooth minute-by-minute fluctuations.
The primary outcome was all-cause mortality within 30 days after surgery. Multivariable logistic regression and sensitivity analyses were performed to adjust for potential confounders. The study aimed to provide clinical insight into the prognostic value of intraoperative heart rate dynamics and to identify modifiable intraoperative risk factors for mortality.
- Conditions
- HEART RATE
- Being tested
- Intraoperative Heart Rate Monitoring
- Keywords
- Heart rate, Intraoperative, Tachycardia, Bradycardia, Mortality
- Medical subject headings
- Tachycardia, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Heart Rate MonitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intraoperative Heart Rate Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after the date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start30 Aug 2023
- Primary completion31 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEART RATEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 139,149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Hoon Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075744
- Sponsor's protocol ID
- AMC [2023-0611]
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Individual data sharing
- No: The dataset used and/or analyzed during the current study is available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Intraoperative Heart Rate and Postoperative 30-day Mortality in Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT07075744
- Acronym / sponsor ID
- AMC [2023-0611]
- Conditions
- HEART RATE
- Keywords
- Heart rate, Intraoperative, Tachycardia, Bradycardia, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139,149 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective cohort study conducted to evaluate the clinical impact of intraoperative heart rate on postoperative 30-day mortality in patients undergoing non-cardiac surgery. Patient data were extracted from a large institutional electronic medical record database, including demographic variables, comorbidities, anesthesia records, and perioperative outcomes.
Heart rate was continuously recorded at 1-minute or 5-minute intervals during the surgery. Various heart rate parameters-such as minimum, maximum, average, and time-weighted average-were analyzed, and threshold-based metrics (e.g., minutes spent below or above defined thresholds) were computed using a piecewise cubic Hermite interpolating polynomial (PCHIP) method to smooth minute-by-minute fluctuations.
The primary outcome was all-cause mortality within 30 days after surgery. Multivariable logistic regression and sensitivity analyses were performed to adjust for potential confounders. The study aimed to provide clinical insight into the prognostic value of intraoperative heart rate dynamics and to identify modifiable intraoperative risk factors for mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-cardiac Surgery Cohort | – | Other: Intraoperative Heart Rate MonitoringThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Cardiac-related surgical procedures
- Pregnancy at the time of surgery
- Age < 18 years
- Surgeries lasting less than 30 minutes
- Cadaveric procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Heart Rate MonitoringThis 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. | Other | Non-cardiac Surgery Cohort |
Primary outcome
All-cause mortality within 30 days after non-cardiac surgery
Time frame: 30 days after the date of 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No. The dataset used and/or analyzed during the current study is available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HEART RATE, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality within 30 days after non-cardiac surgery (time frame: 30 days after the date of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.