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临床试验/NCT04136210
NCT04136210已完成不适用

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

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 1,568 人开始时间: 2019年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,568
试验地点
1
主要终点
Intraoperative and postoperative data

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing cardiac or thoracic aortic surgery

排除标准

  • refused to participate

结局指标

主要结局

Intraoperative and postoperative data

时间窗: During surgery and until 48 hours after surgery

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

Postoperative ICU data

时间窗: 1 year after surgery

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.

Complications

时间窗: 1 year after surgery

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

Operation data

时间窗: During surgery

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

Baseline characteristics

时间窗: Before surgery

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

Preoperative data

时间窗: Before surgery

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yunseok Jeon

Professor

Seoul National University Hospital

研究点 (1)

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