Venous congestion during heart surgery and risk of postoperative kidney injury

Intraoperative Venous Congestion and Cardiac Surgery-associated Acute Kidney Injury (CSA-AKI): a Prospective Cohort Study

This study will see if measuring venous congestion during elective heart surgery helps predict who develops acute kidney injury afterward.

Quick facts

• Study type: Observational
• Enrollment: 114 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yangzhou University (Academic / other)
• Locations: 1 site (Yangzhou, Jiangsu)
• Trial ID: NCT07232277 on ClinicalTrials.gov

What this trial studies

This observational study enrolls adults undergoing elective cardiac surgery and collects demographic, surgical, hemodynamic, echocardiographic, venous ultrasound, laboratory, and kidney function data before, during, and after the operation. Transesophageal echocardiography and venous Doppler measurements will be used to quantify intraoperative venous blood stasis and right-sided filling pressures alongside routine hemodynamic monitoring. Investigators will correlate these venous congestion markers with postoperative acute kidney injury and other organ dysfunction while excluding patients with severe preexisting kidney disease, emergency or redo operations, and conditions that interfere with venous flow interpretation. The aim is to identify intraoperative venous patterns that predict postoperative renal outcomes and inform future preventive strategies.

Who should consider this trial

Good fit: Adults (≥18) scheduled for elective cardiac surgery who can undergo transesophageal echocardiography and do not have severe preexisting kidney disease or conditions that interfere with venous flow measurements.

Not a fit: People having emergency or redo cardiac procedures, with severe chronic kidney disease, prior kidney transplant, or liver/venous disorders that prevent clear venous assessments are unlikely to benefit.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify patients at high risk for AKI during surgery so they can adjust management to protect the kidneys.

How similar studies have performed: Prior critical care and heart-failure studies have linked venous congestion to kidney dysfunction, but using intraoperative venous Doppler and TEE to predict post-cardiac surgery AKI is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients scheduled to undergo elective cardiac surgery;
2. ≥ 18 years.

Exclusion Criteria:

1. Contraindications for TEE;
2. Emergency cardiac surgery;
3. Major vascular surgery;
4. Redo cardiac surgery;
5. Abnormal preoperative renal function;
6. Severe chronic kidney disease (estimated glomerular filtration rate \< 15 ml/min/1.73 m2 or dialysis);
7. History of kidney transplantation;
8. Severe infection requiring continuous antibiotic therapy；
9. Severe preoperative heart failure with left ventricular ejection fraction \< 30%;
10. A critical preoperative state (mechanical circulatory support, extracorporeal membrane oxygenation, current renal replacement therapy \[RRT\], mechanical ventilation, or cardiac arrest necessitating resuscitation);
11. Multi-organ dysfunction;
12. 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 and renal artery blood flow (such as urinary tract obstruction);
13. Planned cardiac transplantation or ventricular assist device implantation;
14. Pregnancy;
15. Insufficient ultrasonographic imaging;
16. Restarting CPB after first CPB cessation during surgery;
17. Requirement for cardiac assist devices (ECMO, IABP, or ventricular assist device) after CPB intraoperatively.

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; Cardiac Surgery-associated Acute Kidney Injury