Study Results
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Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2024-11-01
2026-10-31
Brief Summary
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Systemic venous congestion can occur when there is right heart dysfunction or excessive volume load. When right heart failure and/or volume overload occurs, changes in right atrial pressure are transmitted to the venous system of organs throughout the body, with dilatation of the inferior vena cava (IVC), obstruction of blood return from the hepatic, portal, and renal veins, and abnormal venous flow signals and altered ultrasound Doppler flow patterns.
The primary objective of this prospective cohort study is to explore if intraoperative systemic venous congestion is associated with POD after cardiac surgery. This study will also investigate the relationship between intraoperative systemic venous congestion and postoperative complications, and the relationship between each separate venous congestion and POD after cardiac surgery.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adult patients scheduled to undergo elective cardiac surgery
collection of demographic characteristics and comorbidities
1. gender, age, BMI, ASA classification, NYHA (New York Heart Association) classification, MMSE score.
2. smoking history, medical history (hypertension, diabetes mellitus, Hyperlipidemia, stroke, anaemia, chronic obstructive pulmonary disease, pulmonary hypertension, preoperative atrial fibrillation, peripheral artery disease), preoperative ACEI, ARB, beta-blockers, loop diuretics, aspirin, and spironolactone use.
surgery-related parameters
1. surgery type, surgery duration, CPB duration, aortic cross-clamp duration, blood loss, intraoperative fluid infusion, intraoperative urine output, intraoperative blood transfusion, intraoperative anesthetics and vasoactive medications.
2. duration of mechanical ventilation, duration of vasopressor support, postoperative acute kidney injury incidence and CRRT initiation, major bleeding, deep sternal wound infection/mediastinitis, surgical re-intervention, ICU LOS, hospital LOS, postoperative stroke, complications up to 30 days after surgery, 30-day inpatient mortality, survival status at discharge, and one year follow-up.
3. a composite endpoint of major complications after surgery defined as at least one of the following: death, prolonged ventilation (\>24 h), stroke, severe AKI, deep sternal wound infection, and reoperation for any reason.
POD assessments
Assessments of POD during the first 7 days postoperatively.
collection of biological (laboratory) parameters
1. WBC, CRP, IL-6, IL-10, IL-1β, TNF-α, serum Amyloid A, procalcitonin, catecholamines, cortisol, SOD, HIF-1α;
2. BDNF, S-100β protein, NSE;
3. CK-MB, NT pro-BNP, BNP, high-sensitivity troponin level;
4. hemoglobin, hematocrit, sodium, arterial lactate, and liver enzymes.
collection of hemodynamic parameters
1. blood pressure, heart rate, CVP;
2. CO, CI, SV, SVI,SVV;
3. intra-abdominal pressure;
4. vasoactive drug doses in the first hour in the ICU.
collection of echocardiographic parameters and venous ultrasound assessments
(1) Left ventricle systolic function, including LVOT, LVEF, MPI; left ventricular diastolic function, including mitral flow-derived Doppler indices, pulmonary vein Doppler indices. (2) Right ventricular systolic function, including TAPSE. Right ventricular diastolic dysfunction, inferred from an abnormal hepatic vein flow (systolic velocity \< diastolic velocity) in the absence of a dysrhythmia or pacing. (3) Inferior vena cava (IVC) measurements. (4) Hepatic vein Doppler parameters. (5) Portal vein Doppler parameters. (6) Renal vein Doppler parameters.
collection of parameters monitoring on the central nervous system
1. Regional cerebral oximetry.
2. Brain wave patterns.
3. Optic nerve sheath diameter.
Interventions
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collection of demographic characteristics and comorbidities
1. gender, age, BMI, ASA classification, NYHA (New York Heart Association) classification, MMSE score.
2. smoking history, medical history (hypertension, diabetes mellitus, Hyperlipidemia, stroke, anaemia, chronic obstructive pulmonary disease, pulmonary hypertension, preoperative atrial fibrillation, peripheral artery disease), preoperative ACEI, ARB, beta-blockers, loop diuretics, aspirin, and spironolactone use.
surgery-related parameters
1. surgery type, surgery duration, CPB duration, aortic cross-clamp duration, blood loss, intraoperative fluid infusion, intraoperative urine output, intraoperative blood transfusion, intraoperative anesthetics and vasoactive medications.
2. duration of mechanical ventilation, duration of vasopressor support, postoperative acute kidney injury incidence and CRRT initiation, major bleeding, deep sternal wound infection/mediastinitis, surgical re-intervention, ICU LOS, hospital LOS, postoperative stroke, complications up to 30 days after surgery, 30-day inpatient mortality, survival status at discharge, and one year follow-up.
3. a composite endpoint of major complications after surgery defined as at least one of the following: death, prolonged ventilation (\>24 h), stroke, severe AKI, deep sternal wound infection, and reoperation for any reason.
POD assessments
Assessments of POD during the first 7 days postoperatively.
collection of biological (laboratory) parameters
1. WBC, CRP, IL-6, IL-10, IL-1β, TNF-α, serum Amyloid A, procalcitonin, catecholamines, cortisol, SOD, HIF-1α;
2. BDNF, S-100β protein, NSE;
3. CK-MB, NT pro-BNP, BNP, high-sensitivity troponin level;
4. hemoglobin, hematocrit, sodium, arterial lactate, and liver enzymes.
collection of hemodynamic parameters
1. blood pressure, heart rate, CVP;
2. CO, CI, SV, SVI,SVV;
3. intra-abdominal pressure;
4. vasoactive drug doses in the first hour in the ICU.
collection of echocardiographic parameters and venous ultrasound assessments
(1) Left ventricle systolic function, including LVOT, LVEF, MPI; left ventricular diastolic function, including mitral flow-derived Doppler indices, pulmonary vein Doppler indices. (2) Right ventricular systolic function, including TAPSE. Right ventricular diastolic dysfunction, inferred from an abnormal hepatic vein flow (systolic velocity \< diastolic velocity) in the absence of a dysrhythmia or pacing. (3) Inferior vena cava (IVC) measurements. (4) Hepatic vein Doppler parameters. (5) Portal vein Doppler parameters. (6) Renal vein Doppler parameters.
collection of parameters monitoring on the central nervous system
1. Regional cerebral oximetry.
2. Brain wave patterns.
3. Optic nerve sheath diameter.
Eligibility Criteria
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Inclusion Criteria
2. ≥18 years;
3. A preoperative MMSE score\>23, without consciousness or language barriers, capable of cooperating with neurological examinations, cognitive function tests, and other assessments of neurological function.
Exclusion Criteria
2. Emergency cardiac surgery;
3. Major vascular surgery;
4. Redo cardiac surgery;
5. Severe infection requiring continuous antibiotic therapy;
6. Severe preoperative heart failure with left ventricular ejection fraction \< 30%;
7. A critical preoperative state (mechanical circulatory support, extracorporeal membrane oxygenation, current renal replacement therapy, mechanical ventilation, or cardiac arrest necessitating resuscitation);
8. Multi-organ dysfunction;
9. Known conditions that may interfere with the assessment or interpretation of hepatic vein, portal vein blood flow (such as liver cirrhosis or portal vein thrombosis) or the renal vein blood flow (such as urinary tract obstruction);
10. Planned cardiac transplantation or ventricular assist device implantation;
11. Pregnancy;
12. Insufficient ultrasonographic imaging;
13. Restarting CPB after first CPB cessation during surgery;
14. Requirement for cardiac assist devices (ECMO, IABP, or ventricular assist device) after CPB intraoperatively;
15. Neurological or psychiatric diagnoses that may affect cognitive performance or cognitive testing;
16. Documented delirium before surgery.
18 Years
ALL
No
Sponsors
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Zhuan Zhang
OTHER
Responsible Party
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Zhuan Zhang
MD, the Deputy Director of Anesthesiology, the Affiliated Hospital of Yangzhou University, Yangzhou University
Principal Investigators
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Zhuan Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
The Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University
Locations
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No. 368 Hanjiang Middle Road
Yangzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Zhuan Zhang, MD
Role: primary
Other Identifiers
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20240915
Identifier Type: -
Identifier Source: org_study_id