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Venous Congestion And Delirium After Cardiac Surgery

Recruitingn/aAges 18 Years - anyAllZhuan Zhang
NCT07285187 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Postoperative delirium (POD) is an acute brain dysfunction characterized by inattention, impaired consciousness, and cognitive and orientation disturbances, and is a common complication after cardiac surgery. The high incidence of up to 52% of POD in cardiac surgery patients lead to a range of adverse clinical outcomes.The brain tissue is enclosed in a rigid anatomical structure; when there is an obstruction to venous return from the brain, intracranial pressure can increase, and blood supply to the brain tissue can decrease, leading to central nervous system dysfunction. 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 o

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients scheduled to undergo elective cardiac surgery via a midline thoracic incision; 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: 1. Contraindications for TEE; 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.
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What it tests

  • collection of demographic characteristics and comorbidities
  • surgery-related parameters
  • POD assessments
  • collection of biological (laboratory) parameters
  • collection of hemodynamic parameters
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Where

1 site
No. 368 Hanjiang Middle Road
Yangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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