Actively Recruiting

Age: 18Years +
All Genders
NCT07285187

Venous Congestion And Delirium After Cardiac Surgery

Led by Zhuan Zhang · Updated on 2025-12-23

120

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 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.

CONDITIONS

Official Title

Venous Congestion And Delirium After Cardiac Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled to undergo elective cardiac surgery via a midline thoracic incision
  • Age 18 years or older
  • Preoperative Mini-Mental State Examination (MMSE) score greater than 23, without consciousness or language barriers, able to cooperate with neurological and cognitive assessments
Not Eligible

You will not qualify if you...

  • Contraindications for transesophageal echocardiography (TEE)
  • Emergency cardiac surgery
  • Major vascular surgery
  • Repeat cardiac surgery
  • Severe infection requiring continuous antibiotic therapy
  • Severe preoperative heart failure with left ventricular ejection fraction less than 30%
  • Critical preoperative state requiring mechanical circulatory support, extracorporeal membrane oxygenation, renal replacement therapy, mechanical ventilation, or cardiac arrest resuscitation
  • Multi-organ dysfunction
  • Conditions interfering with assessment of hepatic, portal, or renal vein blood flow (e.g., liver cirrhosis, portal vein thrombosis, urinary tract obstruction)
  • Planned cardiac transplantation or ventricular assist device implantation
  • Pregnancy
  • Insufficient ultrasound imaging quality
  • Restarting cardiopulmonary bypass after initial cessation during surgery
  • Requirement for cardiac assist devices (ECMO, IABP, ventricular assist device) after cardiopulmonary bypass intraoperatively
  • Neurological or psychiatric diagnoses affecting cognitive testing
  • Documented delirium before surgery

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

No. 368 Hanjiang Middle Road

Yangzhou, Jiangsu, China, 225012

Actively Recruiting

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Research Team

Z

Zhuan Zhang, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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