Venous congestion and thinking problems after heart surgery

Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac Surgery: A Prospective Cohort Study

This project will see if venous congestion during and after elective heart surgery is linked to thinking and memory problems in adult patients.

Quick facts

• Study type: Observational
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yangzhou University (Academic / other)
• Locations: 1 site (Yangzhou, Jiangsu)
• Trial ID: NCT07483151 on ClinicalTrials.gov

What this trial studies

Adult patients undergoing elective midline thoracic cardiac surgery will have clinical, hemodynamic, laboratory, and cognitive data collected before, during, and after the operation. Intraoperative monitoring including transesophageal echocardiography and standard hemodynamic measurements will be used to characterize venous congestion. Cognitive function will be measured with preoperative and serial postoperative tests (including MMSE and POCD assessments) to track changes over time. Demographics, comorbidities, and surgery-related parameters will be recorded to correlate with venous congestion markers and cognitive outcomes.

Who should consider this trial

Good fit: Adults aged 18 or older scheduled for elective midline thoracic cardiac surgery who have a preoperative MMSE > 23 and can cooperate with cognitive testing and transesophageal echocardiography are ideal candidates.

Not a fit: Patients undergoing emergency, redo, or major vascular surgery, those with severe preoperative heart failure, multi-organ dysfunction, contraindications to TEE, or conditions that interfere with venous flow assessment (e.g., advanced liver disease) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify modifiable venous congestion factors to reduce postoperative cognitive decline after cardiac surgery.

How similar studies have performed: Prior studies have linked intraoperative hemodynamic instability and impaired cerebral perfusion to postoperative cognitive dysfunction, but directly studying venous congestion as a driver of POCD is relatively novel.

Eligibility criteria

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

Where this trial is running

Yangzhou, Jiangsu

• The Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University — Yangzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zhuan Zhang, MD

Conditions Intraoperative Venous Congestion And Cognitive Dysfunction After Cardiac Surgery; Venous Congestion; Cardiac Surgery; Postoperative cognitive dysfunction