Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06972082

Prevention and Treatment of Acute Kidney Injury After Cardiac Surgery Guided by Combined Cardiac and Splanchnic Sonographic Assessment

Led by Onassis Cardiac Surgery Centre · Updated on 2025-05-14

304

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether using ultrasound to evaluate venous congestion in the liver and kidneys can help guide treatment and prevent or manage acute kidney injury after cardiac surgery (CSA-AKI). This trial focuses on patients developing CSA-AKI, a common and serious complication with significant risks including increased mortality and progression to chronic kidney failure. The study explores a new ultrasound method called the Venous Excess Ultrasound Score (VEXUS) to better assess venous congestion, which may improve individualized fluid and drug management compared to standard care. Participants are assigned to one of two groups: a control group receiving standard care, and a treatment group where fluid and drug therapies are guided by VEXUS ultrasound measurements to minimize acute kidney injury. The trial involves daily monitoring of kidney function, fluid balance, and laboratory tests. The study uses randomized allocation without masking and collects data over the postoperative period up to ICU discharge. The VEXUS method combines ultrasound assessments of the inferior vena cava and Doppler evaluations of blood flow in liver and kidney veins. During the study, participants will have daily evaluations of kidney function including blood urea and creatinine levels at specific time points, alongside fluid balance tracking and laboratory examinations for up to seven days or until discharge. The researchers record all data for statistical analysis to determine if VEXUS-guided therapy improves kidney outcomes after cardiac surgery. The study includes monitoring for safety and effectiveness throughout the ICU stay and captures changes in renal function over time.

CONDITIONS

Brief Title

Prevention and Treatment of AKI VEXUS Guided Post Cardiac Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients in the Cardiac Surgery ICU who develop acute kidney injury according to KDIGO criteria within 48 hours of ICU admission after cardiac surgery
  • Elective and non-elective cardiac surgery
Not Eligible

You will not qualify if you...

  • Patient refusal
  • Severe chronic renal failure (GFR less than 15 mL/min/m2 or on hemodialysis)
  • Critical preoperative condition such as severe cardiogenic shock, resuscitated cardiac arrest, or support with mechanical circulatory assist devices
  • Liver cirrhosis or inferior vena cava obstruction
  • Pregnancy
  • Morbid obesity (BMI greater than 40 kg/m2)
  • Delirium or other conditions preventing performance of ultrasound study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) before surgery

Treatment

Duration - Up to 7 days post-surgery or until ICU discharge

Participants undergo cardiac surgery and receive either standard care or goal-directed fluid therapy guided by VEXUS ultrasound measurements to minimize acute kidney injury.

Multiple assessments within 7 days after surgery, including at 24, 48, 72 hours, 7th day, and ICU discharge

Trial Site Locations

Total: 1 location

1

Onassis Cardiac Surgery Center

Athens, Kallithea, Greece, 17674

Actively Recruiting

Loading map...

Research Team

S

Stavros Dimopoulos, PhD, EDIC

K

Konstantina Kolonia, MD, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

A Double-blind Non Inferiority Clinical Trial to Compare the...

Debulking Surgery for Ovarian Cancer

Actively Recruiting

1 location

A Monitoring System Based on the Multifactorial Dynamic Perf...

Cardiac Diseases

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here