Registry Construction for Perioperative Data in Patients... | NCT04136210

NCT04136210

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
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

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37620412	Derived	Lee S, Jung DE, Park D, Kim TJ, Lee HC, Bae J, Nam K, Jeon Y, Cho YJ. Intraoperative neurological pupil index and postoperative delirium and neurologic adverse events after cardiac surgery: an observational study. Sci Rep. 2023 Aug 24;13(1):13838. doi: 10.1038/s41598-023-41151-z.