Prevention and Treatment of AKI VEXUS Guided Post Cardiac Surgery (NCT06972082) | Clinical Trial Compass
RecruitingNot Applicable
Prevention and Treatment of AKI VEXUS Guided Post Cardiac Surgery
Greece304 participantsStarted 2023-06-29
Plain-language summary
The main goal of this clinical trial is to learn if evaluation by ultrasound of venous congestion of liver and kidneys can guide treatment and prevent and treat acute kidney injury post cardiac surgery (CSA-AKI).
Participants will:
Be evaluated by liver and kidney veins ultrasound (treatment group) or a placebo post CSA-AKI.
Fluid management for the treatment group will be based on a score that emerges from this evaluation (Venous Excess Ultrasound Score, VEXUS).
Kidney function will be daily monitored and followed-up for 7 days and until discharge.
Daily fluid balance and laboratory examination will be performed. Data will be recorded and collected and a statistical analysis will provide the results that will show or not a probable superiority of this evaluation comparing to the usual care.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Patient refusal
* Severe chronic renal failure (GFR\<15 mL/min/m2 or on hemodialysis).
* Critical preoperative condition (severe cardiogenic shock, resuscitated cardiac arrest, support with mechanical circulatory assist devices).
* Liver cirrhosis or inferior vena cava obstruction.
* Pregnancy.
* Morbid obesity (BMI\>40 kg/m2).
* Delirium or other condition that prevents the performance of an ultrasound study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Renal function
Timeframe: Record Urea, Creatinine (preoperative value, enrollment day, post-operatively: 24hours-, 48hours-, 72hours-, 7th day-, at ICU discharge)