Registry Construction for Perioperative Data in Patients Undergoing Cardiovascular Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04136210
• Other study ID #: Heart Registry
• Status: Recruiting
• Start date: September 19, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing cardiac or thoracic aortic surgery

Exclusion Criteria:

• refused to participate

Related Conditions & MeSH terms

• Anesthesia
• Cardiac Surgery

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Before surgery
Primary	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	Before surgery
Primary	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	During surgery and until 48 hours after surgery
Primary	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	During surgery
Primary	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.	1 year after surgery
Primary	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	1 year after surgery