Registry Construction for Perioperative Data in Patients Undergoing Cardiovascular Surgery

November 28, 2023 updated by: Yunseok Jeon, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Yunseok Jeon, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing cardiac or thoracic aortic surgery

Description

Inclusion Criteria:

  • patients undergoing cardiac or thoracic aortic surgery

Exclusion Criteria:

  • refused to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline characteristics
Time Frame: 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
Before surgery
Preoperative data
Time Frame: 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
Before surgery
Intraoperative and postoperative data
Time Frame: 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
During surgery and until 48 hours after surgery
Operation data
Time Frame: 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
During surgery
Postoperative ICU data
Time Frame: 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.
1 year after surgery
Complications
Time Frame: 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
1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 13, 2019

First Submitted That Met QC Criteria

October 20, 2019

First Posted (Actual)

October 23, 2019

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Heart Registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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