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Completed

NCT Number: NCT04136210

Registry Construction for Perioperative Data in Patients Undergoing Cardiovascular Surgery

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing cardiac or thoracic aortic surgery

Exclusion criteria

  • refused to participate

Treatment and study plan

Primary outcomes

  1. Baseline characteristics

    Time frame: Before surgery

    • 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
  2. Preoperative data

    Time frame: Before surgery

    • 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
  3. Intraoperative and postoperative data

    Time frame: During surgery and until 48 hours after surgery

    • 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
  4. Operation data

    Time frame: During surgery

    • 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
  5. Postoperative ICU data

    Time frame: 1 year after surgery

    • 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.
  6. Complications

    Time frame: 1 year after surgery

    • 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Oct 23, 2019
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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