Cardiac SurgeryNCT04136210
Registry Construction for Perioperative Data in Patients Undergoing Cardiovascular Surgery
An observational study of Cardiac Surgery and Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this registry is to obtain perioperative data in patients undergoing cardiac or thoracic aortic surgery and find out relations between the data and investigate several causes affecting postoperative complications. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiac Surgery, Anesthesia
- How many people
- 1,568 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Sep 2019to 8 Jan 2025
- How long will I take part?
- 1 Year
- 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 or thoracic aortic surgery
Who may be able to join
- patients undergoing cardiac or thoracic aortic surgery
Who cannot join
- refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Clinical, Hemodynamic Data and Prognosis Assessment in Patients Who Undergo Cardiovascular Surgery; Registry Construction
The purpose of this registry is to obtain perioperative data in patients undergoing cardiac or thoracic aortic surgery and find out relations between the data and investigate several causes affecting postoperative complications.
- Conditions
- Cardiac Surgery, Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline characteristics
- Sex
- Age
- Height
- Weight
- Body mass index
- Underlying disease Family history
- Previous operation history
- Current medication Preoperative hemodialysis
- Preoperative cardiopulmonary resuscitation
- Preoperative mechanical ventilation
- Preoperative intra-aortic balloon pump
- Preoperative intravenous drug and dose
- Alcohol history, smoking history
- Drug allergy
- Functional capacity, ASA classification, NYHA class
- EuroSCORE, STS score, SOFA score
Measured: Before surgery
Preoperative data
- Vital sign including systolic blood pressure, diastolic blood pressure, mean blood pressure, pulse pressure, heart rate, SpO2, body temperature, consciousness, GCS (Glasgow Coma Scale), central venous pressure, pulmonary arterial pressure, and respiratory rate
- Laboratory data including CBC (Hb, Hct, WBC, platelet), Electrolyte (Na, K, Ca, Mg), coagulation (PT INR, aPTT, fibrinogen), ABGA (Hct, pH, pCO2, pO2, HCO3-, BE, SaO2), BUN/Creatinine, OT/PT, Total bilirubin, CRP, cardiac enzyme (Troponin I, CK, CK-MB), albumin, glucose, HbA1C, lactate, and creatinine clearance
- ABGA (Hct, pH, pCO2, pO2, HCO3-, BE, SaO2, Na, K, iCa, Glucose, Lactic acid)
- Imaging data including chest X-ray, chest CT, Brain MRI/A, coronary angiography, CT angiography, cardiac MRI, myocardiac SPECT, and abdomen CT
- ECG (rhythm, QTc interval), PFT, Echocardiography (Ejection fraction, RWMA, Pulmonary HTN, Valve abnormality), and esophagogastroduodenoscopy
Measured: Before surgery
Intraoperative and postoperative data
- Vital sign
- ECG analysis
- Stroke volume variation, pulse pressure variation
- Cardiac index, cardiac output, stroke volume, mixed venous oxygen saturation
- Airway and respiratory indicators
- Bispectral index
- Patient state index (PSi)
- Tissue oxygen saturation of brain and limbs
- Tissue oxygen saturation (StO2) during vascular occlusion test (VOT)
- Transcutaneous CO2 (PtcCO2), transcutaneous O2 (PtcO2)
- Sublingual SDF imaging (MicroScan; MicroVision Medical, Amsterdam, the Netherlands)
- Pupil reactivity assessment scale
- Coagulation: ROTEM, Multiplate
- Laboratory data
- ABGA
- Cardiac enzyme
Measured: During surgery and until 48 hours after surgery
Operation data
- Type of operation
- Emergency or elective
- Types and doses of anesthetics, anesthesia time, surgery time
- Location of arterial lines
- Infused fluid and dose, estimated blood loss, blood transfusion, and urine output
- Coronary artery bypass surgery: type of bypass artery, bypass time for each artery
- Cardiopulmonary bypass A. Cardiopulmonary bypass protocol B. Types and doses of used drug, rewarming time, duration of CPB, time of aortic clamping, transfusion dose
- Aortic arch surgery: total circulatory arrest, circulatory arrest duration, cerebral perfusion
- Intraoperative TEE finding
- Assist device including IABP, ECMO, LVAD, and RVAD
- Rescue drug usage and dose
- Tranexamic acid and vitamin K usage
- Drug reaction or specific event
Measured: During surgery
Postoperative ICU data
- Imaging data including chest X-ray, chest CT, Brain MR/CT, Echocardiography
- Mechanical ventilation duration
- ICU stay duration
- Hospital stay duration
- Postoperative pain control, sedatives
- Drug usage and dose (Epinephrine, norepinephrine, dobutamine, dopamine, milrinone, vasopressin, nitroglycerin, phenylephrine, calcium chloride, lidocaine, amiodarone, digoxin, diltiazem, bicarbonate, and adenosine)
- Assist device including IABP, ECMO, LVAD, and RVAD
- Infused fluid and dose (crystalloid, colloid), estimated blood loss, blood transfusion (RBC, FFP, Platelet, cryoprecipitate, self-blood salvage), urine output at ICU admission, 24 hours / 48 hours after ICU admission.
Measured: 1 year after surgery
Complications
- Cardiac complications
- Respiratory complications
- Neurologic complications
- Renal complications
- Infectious complications
- Gastrointestinal complications
- Adverse drug reaction
- Bleeding complications
- Thrombotic complications
- Postoperative multiorgan failure (SOFA score)
- Mortality including in hospital mortality
- Re-operation
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start19 Sep 2019
- Primary completion30 Dec 2024
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies 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
- Prospective
- Enrolment
- 1,568 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136210
- Sponsor's protocol ID
- Heart Registry
- Status last verified
- May 2025
- First submitted
- 13 Oct 2019
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee S, Jung DE, Park D, Kim TJ, Lee HC, Bae J, Nam K, Jeon Y, Cho YJ. Intraoperative neurological pupil index and postoperative delirium and neurologic adverse events after cardiac surgery: an observational study. Sci Rep. 2023 Aug 24;13(1):13838. doi: 10.1038/s41598-023-41151-z.
PubMed 37620412
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Clinical, Hemodynamic Data and Prognosis Assessment in Patients Who Undergo Cardiovascular Surgery; Registry Construction
- ClinicalTrials.gov ID
- NCT04136210
- Acronym / sponsor ID
- Heart Registry
- Conditions
- Cardiac Surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,568 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 23 Oct 2019 (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.
The purpose of this registry is to obtain perioperative data in patients undergoing cardiac or thoracic aortic surgery and find out relations between the data and investigate several causes affecting postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
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 or thoracic aortic surgery
Key inclusion criteria (1 listed)
- patients undergoing cardiac or thoracic aortic surgery
Key exclusion criteria (1 listed)
- refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline characteristics
Time frame: Before surgery
1. Sex 2. Age 3. Height 4. Weight 5. Body mass index 6. Underlying disease Family history 7. Previous operation history 8. Current medication Preoperative hemodialysis 9. Preoperative cardiopulmonary resuscitation 10. Preoperative mechanical ventilation 11. Preoperative intra-aortic balloon pump 12. Preoperative intravenous drug and dose 13. Alcohol history, smoking history 14. Drug allergy 15. Functional capacity, ASA classification, NYHA class 16. EuroSCORE, STS score, SOFA score
Preoperative data
Time frame: Before surgery
1. Vital sign including systolic blood pressure, diastolic blood pressure, mean blood pressure, pulse pressure, heart rate, SpO2, body temperature, consciousness, GCS (Glasgow Coma Scale), central venous pressure, pulmonary arterial pressure, and respiratory rate 2. Laboratory data including CBC (Hb, Hct, WBC, platelet), Electrolyte (Na, K, Ca, Mg), coagulation (PT INR, aPTT, fibrinogen), ABGA (Hct, pH, pCO2, pO2, HCO3-, BE, SaO2), BUN/Creatinine, OT/PT, Total bilirubin, CRP, cardiac enzyme (Troponin I, CK, CK-MB), albumin, glucose, HbA1C, lactate, and creatinine clearance 3. ABGA (Hct, pH, pCO2, pO2, HCO3-, BE, SaO2, Na, K, iCa, Glucose, Lactic acid) 4. Imaging data including chest X-ray, chest CT, Brain MRI/A, coronary angiography, CT angiography, cardiac MRI, myocardiac SPECT, and abdomen CT 5. ECG (rhythm, QTc interval), PFT, Echocardiography (Ejection fraction, RWMA, Pulmonary HTN, Valve abnormality), and esophagogastroduodenoscopy
Intraoperative and postoperative data
Time frame: During surgery and until 48 hours after surgery
1. Vital sign 2. ECG analysis 3. Stroke volume variation, pulse pressure variation 4. Cardiac index, cardiac output, stroke volume, mixed venous oxygen saturation 5. Airway and respiratory indicators 6. Bispectral index 7. Patient state index (PSi) 8. Tissue oxygen saturation of brain and limbs 9. Tissue oxygen saturation (StO2) during vascular occlusion test (VOT) 10. Transcutaneous CO2 (PtcCO2), transcutaneous O2 (PtcO2) 11. Sublingual SDF imaging (MicroScan; MicroVision Medical, Amsterdam, the Netherlands) 12. Pupil reactivity assessment scale 13. Coagulation: ROTEM, Multiplate 14. Laboratory data 15. ABGA 16. Cardiac enzyme
Operation data
Time frame: During surgery
1. Type of operation 2. Emergency or elective 3. Types and doses of anesthetics, anesthesia time, surgery time 4. Location of arterial lines 5. Infused fluid and dose, estimated blood loss, blood transfusion, and urine output 6. Coronary artery bypass surgery: type of bypass artery, bypass time for each artery 7. Cardiopulmonary bypass A. Cardiopulmonary bypass protocol B. Types and doses of used drug, rewarming time, duration of CPB, time of aortic clamping, transfusion dose 8. Aortic arch surgery: total circulatory arrest, circulatory arrest duration, cerebral perfusion 9. Intraoperative TEE finding 10. Assist device including IABP, ECMO, LVAD, and RVAD 11. Rescue drug usage and dose 12. Tranexamic acid and vitamin K usage 13. Drug reaction or specific event
Postoperative ICU data
Time frame: 1 year after surgery
1. Imaging data including chest X-ray, chest CT, Brain MR/CT, Echocardiography 2. Mechanical ventilation duration 3. ICU stay duration 4. Hospital stay duration 5. Postoperative pain control, sedatives 6. Drug usage and dose (Epinephrine, norepinephrine, dobutamine, dopamine, milrinone, vasopressin, nitroglycerin, phenylephrine, calcium chloride, lidocaine, amiodarone, digoxin, diltiazem, bicarbonate, and adenosine) 7. Assist device including IABP, ECMO, LVAD, and RVAD 8. Infused fluid and dose (crystalloid, colloid), estimated blood loss, blood transfusion (RBC, FFP, Platelet, cryoprecipitate, self-blood salvage), urine output at ICU admission, 24 hours / 48 hours after ICU admission.
Complications
Time frame: 1 year after surgery
1. Cardiac complications 2. Respiratory complications 3. Neurologic complications 4. Renal complications 5. Infectious complications 6. Gastrointestinal complications 7. Adverse drug reaction 8. Bleeding complications 9. Thrombotic complications 10. Postoperative multiorgan failure (SOFA score) 11. Mortality including in hospital mortality 12. Re-operation
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 21 May 2025.
- Derived from this study: PubMed 37620412Lee S, Jung DE, Park D, Kim TJ, Lee HC, Bae J, Nam K, Jeon Y, Cho YJ. Intraoperative neurological pupil index and postoperative delirium and neurologic adverse events after cardiac surgery: an observational study. Sci Rep. 2023 Aug 24;13(1):13838. doi: 10.1038/s41598-023-41151-z.
- Individual participant dataSharing planned: No
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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 Cardiac Surgery and Anesthesia, 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 21 May 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?
Baseline characteristics (time frame: Before surgery). The study lists 6 primary outcomes in all. 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 NCT04136210, which also lists 1 linked publication.
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 21 May 2025.