Prevention and Treatment of AKI VEXUS Guided Post Cardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOnassis Cardiac Surgery Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
VEXUS
DeviceGoal-directed fluid and drug therapy according to VEXUS measurements to minimize AKI
Treatment groups
304 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: VEXUSOther 1 intervention
Trial outcomes
Primary outcomes
1
Renal function
Renal function (Creatinine, \[ΔCreatinine, %\]) · Record Urea, Creatinine
Time frame
Record Urea, Creatinine (preoperative value, enrollment day, post-operatively: 24hours-, 48hours-, 72hours-, 7th day-, at ICU discharge)Sponsors and contacts
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Source ClinicalTrials.gov