Registry Construction for Perioperative Data in Patients Undergoing Cardiovascular Surgery

NCT04136210 | Completed

• 1 other identifier: Heart Registry
• Study Type: observational
• Target: 1,568
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Anesthesia

Outcome Measures

Primary Outcomes (6)

• Baseline characteristics

  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

  Before surgery

• Preoperative data

  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

  Before surgery

• Intraoperative and postoperative data

  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

  During surgery and until 48 hours after surgery

• Operation data

  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

  During surgery

• Postoperative ICU data

  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.

  1 year after surgery

• Complications

  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

  1 year after surgery

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing cardiac or thoracic aortic surgery

You may qualify if:

• patients undergoing cardiac or thoracic aortic surgery

You may not qualify if:

• refused to participate

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• 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.

  PMID: 37620412 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 23, 2019
• Study Start: September 19, 2019
• Primary Completion: December 30, 2024
• Study Completion: January 8, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)