Blood PressureNCT03785132
Performance Measurement in Cardiac Surgery
An observational study of Blood Pressure, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aimed to evaluate the relationship between the perioperative blood pressure and postoperative mortality after cardiac surgery using performance measurement (PM) of mean arterial pressure (MAP). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2018to 1 Nov 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016 at Seoul National University Hospital
Who may be able to join
- Patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016 at Seoul National University Hospital.
Who cannot join
- Patients without information on preoperative blood pressure or mortality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Performance Measurement of Intraoperative Mean Arterial Pressure and Mortality in Patients Undergoing Cardiac Surgery
This study aimed to evaluate the relationship between the perioperative blood pressure and postoperative mortality after cardiac surgery using performance measurement (PM) of mean arterial pressure (MAP).
Read the detailed description
The authors conducted a retrospective cohort study of adult patients who underwent cardiac surgery requiring cardiopulmonary bypass (CPB). Median performance error (MDPE), median absolute performance error (MDAPE), and wobble of MAP were calculated using preoperative MAP as the reference value, and MBPs before, during and after the bypass as measured values. Univariable and multivariable logistic regression analyses were performed using PM parameters to predict in-hospital mortality. Survival after cardiac surgery was compared using the Cox proportional hazard model. Predictability of PM was assessed using the area under the receiver-operating characteristic curve (AUROC).
- Conditions
- Blood Pressure
- Being tested
- Cardiac surgery
- Keywords
- blood pressure, performance measurement, cardiac surgery, mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
The relationship between performance measurement of blood pressure during cardiac surgery (before, during and after cardiopulmonary bypass) and postoperative mortality
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery | Patients who underwent cardiac surgery with cardiopulmonary bypass Receives: Procedure: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
mortality after cardiac surgery
Measured: through study completion, average 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Jun 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Joung Cho, MD, Seoul National University Hospital
- Investigators
- Youn Joung Cho, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785132
- Sponsor's protocol ID
- PM_cardiac surgery
- Status last verified
- Mar 2020
- First submitted
- 20 Dec 2018
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee HC, Ryu HG, Jung CW. Performance measurement of intraoperative systolic arterial pressure to predict in-hospital mortality in adult liver transplantation. Sci Rep. 2017 Aug 1;7(1):7030. doi: 10.1038/s41598-017-07664-0.
PubMed 28765633Yoon S, Park JB, Lee J, Lee HC, Bahk JH, Cho YJ. Relationship between blood pressure stability and mortality in cardiac surgery patients: retrospective cohort study. J Clin Monit Comput. 2021 Aug;35(4):931-942. doi: 10.1007/s10877-020-00631-7. Epub 2021 Jan 3.
PubMed 33389355
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Performance Measurement of Intraoperative Mean Arterial Pressure and Mortality in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03785132
- Acronym / sponsor ID
- PM_cardiac surgery
- Conditions
- Blood Pressure
- Keywords
- blood pressure, performance measurement, cardiac surgery, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 24 Dec 2018 (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 study aimed to evaluate the relationship between the perioperative blood pressure and postoperative mortality after cardiac surgery using performance measurement (PM) of mean arterial pressure (MAP).
Detailed description
The authors conducted a retrospective cohort study of adult patients who underwent cardiac surgery requiring cardiopulmonary bypass (CPB). Median performance error (MDPE), median absolute performance error (MDAPE), and wobble of MAP were calculated using preoperative MAP as the reference value, and MBPs before, during and after the bypass as measured values. Univariable and multivariable logistic regression analyses were performed using PM parameters to predict in-hospital mortality. Survival after cardiac surgery was compared using the Cox proportional hazard model. Predictability of PM was assessed using the area under the receiver-operating characteristic curve (AUROC).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery | – | Procedure: Cardiac surgeryPatients who underwent cardiac surgery with cardiopulmonary bypass |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016 at Seoul National University Hospital
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016 at Seoul National University Hospital.
Key exclusion criteria (1 listed)
- Patients without information on preoperative blood pressure or mortality.
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 |
|---|---|---|
| Cardiac surgeryThe relationship between performance measurement of blood pressure during cardiac surgery (before, during and after cardiopulmonary bypass) and postoperative mortality | Procedure or surgery | cardiac surgery |
Primary outcome
Mortality
Time frame: through study completion, average 3 years
mortality after cardiac surgery
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 4 Mar 2020.
- Results publication: PubMed 28765633Lee HC, Ryu HG, Jung CW. Performance measurement of intraoperative systolic arterial pressure to predict in-hospital mortality in adult liver transplantation. Sci Rep. 2017 Aug 1;7(1):7030. doi: 10.1038/s41598-017-07664-0.
- Derived from this study: PubMed 33389355Yoon S, Park JB, Lee J, Lee HC, Bahk JH, Cho YJ. Relationship between blood pressure stability and mortality in cardiac surgery patients: retrospective cohort study. J Clin Monit Comput. 2021 Aug;35(4):931-942. doi: 10.1007/s10877-020-00631-7. Epub 2021 Jan 3.
- Individual participant dataSharing planned: Undecided
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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.
Youn Joung Cho, MD principal investigator
Seoul National University Hospital
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 Blood Pressure, run by Seoul National University Hospital 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 1 inclusion and 1 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 4 Mar 2020. 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?
Mortality (time frame: through study completion, average 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785132, which also lists 2 linked publications.
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 4 Mar 2020.