Venous congestion and delirium after heart surgery

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

This project will see if venous congestion during and after elective heart surgery is linked to a higher risk of postoperative delirium in adults who can complete cognitive testing.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yangzhou University (Academic / other)
• Locations: 1 site (Yangzhou, Jiangsu)
• Trial ID: NCT07285187 on ClinicalTrials.gov

What this trial studies

This observational cohort will enroll adults having elective cardiac surgery via a midline thoracic incision and monitor venous congestion with intraoperative transesophageal echocardiography (TEE) alongside routine hemodynamic and laboratory measures. Investigators will collect demographics, comorbidities, surgery parameters, serial hemodynamic data, biological labs, and standardized postoperative delirium assessments. Patients must have a preoperative MMSE > 23 and be able to cooperate with cognitive testing; those with contraindications to TEE or major preoperative instability are excluded. The analysis will correlate markers of systemic and hepatic/portal venous congestion (for example IVC dilation and abnormal venous flow signals) with the incidence and timing of postoperative delirium.

Who should consider this trial

Good fit: Adults (≥18 years) scheduled for elective cardiac surgery via a midline thoracic incision who can complete cognitive testing and have a preoperative MMSE > 23 are the intended participants.

Not a fit: Patients having emergency or redo cardiac surgery, those with severe preoperative heart failure (LVEF < 30%), contraindications to TEE, multi-organ dysfunction, or conditions that distort hepatic/portal flow (such as cirrhosis) are unlikely to be eligible or to gain direct benefit from this protocol.

Why it matters

Potential benefit: If successful, the findings could identify perioperative venous congestion signs that help guide monitoring or interventions to reduce delirium after cardiac surgery.

How similar studies have performed: Some prior observational studies have linked systemic venous congestion to organ dysfunction, but using intraoperative venous flow measures specifically to predict postoperative delirium after cardiac surgery 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

• No. 368 Hanjiang Middle Road — Yangzhou, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Zhuan Zhang, MD — The Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University
• Study coordinator: Zhuan Zhang, MD

Conditions Intraoperative; Venous Congestion; Postoperative Delirium; Cardiac Surgery