Actively Recruiting
Intraoperative Venous Congestion and Cardiac Surgery-associated Acute Kidney Injury: a Prospective Cohort Study
Led by Zhuan Zhang · Updated on 2025-11-18
114
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the role of venous pressure during cardiac surgery and its connection to cardiac surgery-associated acute kidney injury (CSA-AKI). Elevated venous pressure and blood stasis can cause swelling in organ tissues, potentially leading to complications like acute kidney injury. This prospective cohort study aims to identify if intraoperative systemic venous congestion is linked to postoperative CSA-AKI and other complications, seeking a physiological marker to help predict the risk. The study involves adult patients scheduled for elective cardiac surgery. Researchers will collect various data including patient demographics, medical history, surgery-related parameters, kidney function, biological laboratory markers, hemodynamic measurements, and echocardiographic and venous ultrasound assessments. These evaluations will help understand how venous congestion during surgery relates to outcomes. The study does not involve experimental treatments but observes and records these parameters throughout the surgical and postoperative periods. Participants will undergo assessments before, during, and after surgery, including ultrasound scans of the heart and veins, blood tests for kidney function and inflammation markers, and monitoring of heart and blood pressure parameters. Researchers will track postoperative complications, kidney injury occurrences, and other clinical outcomes for up to one year. The primary outcome is acute kidney injury defined by specific changes in serum creatinine within 7 days after surgery. This comprehensive monitoring aims to clarify how venous congestion during surgery affects recovery and long-term health.
CONDITIONS
Brief Title
Venous Congestion and Cardiac Surgery-Associated Acute Kidney Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled to undergo elective cardiac surgery
- Age 18 years or older
You will not qualify if you...
- Contraindications for transesophageal echocardiography (TEE)
- Emergency cardiac surgery
- Major vascular surgery
- Redo cardiac surgery
- Abnormal preoperative renal function
- Severe chronic kidney disease (eGFR less than 15 ml/min/1.73 m2 or dialysis)
- History of kidney transplantation
- 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, current renal replacement therapy, mechanical ventilation, or cardiac arrest resuscitation
- Multi-organ dysfunction
- Conditions interfering with hepatic, portal, renal vein or artery blood flow assessment (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 (ECMO, IABP, ventricular assist device)
AI-Screening
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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 kidney function assessments are collected.
1 visit (in-person)
Duration - Up to 1 year after surgery
Participants are monitored for kidney function, complications, and survival status up to one year after surgery with collection of biological, hemodynamic, echocardiographic, and venous ultrasound parameters.
Approximately 6 visits including assessments shortly after surgery and at one year follow-up
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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