Registry Construction for Perioperative Data in Patients Undergoing Cardiovascular Surgery

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04136210
Collaborator
(none)
2,000
1
51.4
38.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Perioperative Clinical, Hemodynamic Data and Prognosis Assessment in Patients Who Undergo Cardiovascular Surgery; Registry Construction
    Actual Study Start Date :
    Sep 19, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Baseline characteristics [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 [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 [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 [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients undergoing cardiac or thoracic aortic surgery
    Exclusion Criteria:
    • refused to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yunseok Jeon, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT04136210
    Other Study ID Numbers:
    • Heart Registry
    First Posted:
    Oct 23, 2019
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 22, 2022