Actively Recruiting
Intraoperative Venous Congestion and Delirium After Cardiac Surgery: A Prospective Cohort Study
Led by Zhuan Zhang · Updated on 2025-12-23
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the connection between intraoperative systemic venous congestion and postoperative delirium (POD) in adults undergoing cardiac surgery. POD is a common complication after heart surgery, marked by confusion, inattention, and cognitive problems, affecting up to 52% of patients. The study also explores how venous congestion relates to other post-surgery complications and brain function disturbances due to altered blood flow and pressure. This prospective cohort study involves adult patients scheduled for elective cardiac surgery using a midline thoracic incision. Researchers will collect various data including patient demographics, medical history, surgery details, and intraoperative factors. They will perform neurological assessments for delirium during the first 7 days after surgery. The study includes detailed monitoring of biological markers, hemodynamic parameters, echocardiographic and venous ultrasound measurements, and central nervous system monitoring such as brain oxygen levels and wave patterns. Participants will undergo multiple evaluations including cognitive tests, ultrasound scans of veins and heart function, laboratory blood tests, and monitoring of vital signs and brain activity. Researchers will track postoperative delirium and other complications up to 30 days after surgery, with follow-up extending to one year. The main outcome measured is the occurrence of delirium within 7 days post-surgery. The study aims to understand how venous congestion during surgery may impact brain function and recovery after cardiac procedures.
CONDITIONS
Brief Title
Venous Congestion And Delirium After Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled to undergo elective cardiac surgery via a midline thoracic incision
- 18 years of age or older
- Preoperative MMSE score greater than 23, without consciousness or language barriers, and able to cooperate with neurological and cognitive tests
You will not qualify if you...
- Contraindications for transesophageal echocardiography (TEE)
- Emergency cardiac surgery
- Major vascular surgery
- Redo cardiac surgery
- Severe infection requiring continuous antibiotic therapy
- Severe preoperative heart failure with left ventricular ejection fraction less than 30%
- Critical preoperative state such as mechanical circulatory support, ECMO, renal replacement therapy, mechanical ventilation, or cardiac arrest requiring resuscitation
- Multi-organ dysfunction
- Known conditions affecting 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 ultrasonographic imaging
- Restarting cardiopulmonary bypass after first cessation during surgery
- Requirement for cardiac assist devices after cardiopulmonary bypass intraoperatively
- Neurological or psychiatric diagnoses affecting cognitive testing
- Documented delirium before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo elective cardiac surgery during which surgery-related parameters and echocardiographic parameters are collected.
1 visit (in-person, surgery day)
Duration - 7 days postoperatively
Participants are assessed for postoperative delirium and monitored for surgery complications, biological, hemodynamic, and central nervous system parameters during the first 7 days after surgery.
Daily visits or assessments for up to 7 days
Duration - Up to 1 year
Participants are followed for survival status and complications up to one year after surgery.
Follow-up visits or assessments depending on clinical schedule
Trial Site Locations
Total: 1 location
1
No. 368 Hanjiang Middle Road
Yangzhou, Jiangsu, China, 225012
Actively Recruiting
Research Team
Z
Zhuan Zhang, MD
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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