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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04136210
Other study ID # Heart Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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