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Registry Construction for Perioperative Data in Patients Undergoing Cardiovascular Surgery

Perioperative Clinical, Hemodynamic Data and Prognosis Assessment in Patients Who Undergo Cardiovascular Surgery; Registry Construction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04136210
Enrollment
1568
Registered
2019-10-23
Start date
2019-09-19
Completion date
2025-01-08
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Cardiac Surgery

Brief 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.

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients undergoing cardiac or thoracic aortic surgery

Exclusion criteria

* refused to participate

Design outcomes

Primary

MeasureTime frameDescription
Baseline characteristicsBefore surgery1. 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 dataBefore surgery1. 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 dataDuring surgery and until 48 hours after surgery1. 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 dataDuring surgery1. 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 data1 year after surgery1. 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.
Complications1 year after surgery1. 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026