Acute Kidney InjuryVEXAKINCT06972082
Prevention and Treatment of AKI VEXUS Guided Post Cardiac Surgery
A study testing VEXUS in people with Acute Kidney Injury and Cardiac Surgery Associated - Acute Kidney Injury, run by Onassis Cardiac Surgery Centre at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Cardiac Surgery Associated - Acute Kidney Injury
- What is being tested?
- VEXUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteGreece
- Study dates
- 29 Jun 2023to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Onassis Cardiac Surgery Center
Athens, Kallithea, 17674
Stavros Dimopoulos, PhD, EDIC, 00306973956974, stdimop@gmail.com
About this study
Official title: Prevention and Treatment of Acute Kidney Injury After Cardiac Surgery Guided by Combined Cardiac and Splanchnic Sonographic Assessment
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:
Read more
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.
Read the detailed description
Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI)Cardiac surgery-associated acute kidney injury (CSA-AKI) is a common and serious complication, with an incidence of up to 40% in cardiac surgery patients. Approximately 3% of these patients will require at least temporary hemodialysis sessions. Patients with AKI have increased perioperative mortality, prolonged ICU stay, increased hospitalization costs, and 25% of them will progress to chronic renal failure within 3 years. It is defined by KDIGO as an increase in serum creatinine > 0.3 mg/dl within 48 hours, or an increase in creatinine >1.5 times the baseline which is known or presumed to have occurred within the previous 7 days, or urine output < 0.5ml/kg/h for 6 hours.A range of factors with increased risk of developing CSA-AKI has been identified: patient-related, anesthesia-related, surgery-related, and cardiopulmonary bypass-related. The pathophysiology is multifactorial and not fully understood. Renal hypoperfusion, reperfusion injury, inflammation, oxidative stress, neurohormonal activation, nephrotoxins, and genetic polymorphisms are involved in the pathophysiology of CSA-AKI. In the vast majority of patients, AKI is a consequence of a decrease in glomerular filtration rate (GFR) due to hemodynamic disturbances.Renal blood flow is determined by the pressure gradient between inflow pressure (mean arterial pressure) and outflow pressure (central venous pressure or intra-abdominal pressure) 1 and by vascular resistance to flow (radius of afferent and efferent renal arteriole). Therefore, the injury may be due to reduced perfusion due to hypovolemia or reduced cardiac output and/or venous congestion. The management of these patients focuses on reversing renal hypoperfusion by improving cardiac output (administration of fluids and/or inotropes), hypotension (vasoconstrictors), congestion (diuretics, hemodialysis), and exposure to nephrotoxic agents. The traditional strategy of fluid administration to restore diuresis and renal function is often ineffective because it does not lead to improved renal perfusion. Moreover, the assessment of response to fluid administration is problematic with the use of central venous pressure and ultrasound assessment of the inferior vena cava, which are commonly used in clinical practice. Aggressive hydration can lead to volume overload, which is associated with peripheral organ dysfunction and increased mortality. Given that AKI due to systemic venous congestion is more common than hypovolemic AKI, the management of these patients should be individualized, taking into account the hemodynamic profile and the possibility of causing damage to peripheral organs. Transthoracic echocardiography is a non-invasive, cost-effective, bedside method for qualitative and quantitative assessment of myocardial function and hemodynamic profile. It can guide the administration of fluids and vasoactive drugs, detect complications, and contribute to etiological diagnosis in patients with renal injury. Its use can improve the outcome of patients with AKI hospitalized in the ICU. Ultrasound can also assess extravascular fluid in the lung even in subclinical congestion with high specificity, and it is useful for monitoring respiratory distress in patients with acute kidney injury. A new multiparametric ultrasound method for assessing splanchnic congestion is the Venous Excess Ultrasound Score (VExUS), the use of which is becoming established in specialized centers. It involves the combined assessment of the size and variation of the inferior vena cava, as well as Doppler assessment of blood flow in the liver (portal, hepatic veins) and kidney (renal vein and artery). VExUS findings can quantify splanchnic congestion even in cases where the results of traditional assessment methods are conflicting or even normal. Also, they are independently associated with acute kidney injury, both in hospitalized patients with heart failure and after cardiac surgery.The integration of multiparametric ultrasound assessment in clinical practice can identify reversible causes early, identify patients who will develop severe renal dysfunction, and recognize complications early. Therefore, it can guide clinical management from empirical approaches and supportive measures to an individualized approach to CSA-AKI in the perioperative period.
- Being tested
- VEXUS
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEXUSDevice
Goal-directed fluid and drug therapy according to VEXUS measurements to minimize AKI
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care |
| VEXUS | Other | Goal-directed fluid therapy according to VEXUS measurements to minimize AKI Receives: Device: VEXUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Renal function (Creatinine, [ΔCreatinine, %]) · Record Urea, Creatinine
Measured: Record Urea, Creatinine (preoperative value, enrollment day, post-operatively: 24hours-, 48hours-, 72hours-, 7th day-, at ICU discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start29 Jun 2023
- Primary completion30 Jun 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onassis Cardiac Surgery Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972082
- Sponsor's protocol ID
- 778/12.06.2023
- Acronym
- VEXAKI
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Acute Kidney Injury After Cardiac Surgery Guided by Combined Cardiac and Splanchnic Sonographic Assessment
- ClinicalTrials.gov ID
- NCT06972082
- Acronym / sponsor ID
- VEXAKI / 778/12.06.2023
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Onassis Cardiac Surgery CentreUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI)Cardiac surgery-associated acute kidney injury (CSA-AKI) is a common and serious complication, with an incidence of up to 40% in cardiac surgery patients. Approximately 3% of these patients will require at least temporary hemodialysis sessions. Patients with AKI have increased perioperative mortality, prolonged ICU stay, increased hospitalization costs, and 25% of them will progress to chronic renal failure within 3 years. It is defined by KDIGO as an increase in serum creatinine > 0.3 mg/dl within 48 hours, or an increase in creatinine >1.5 times the baseline which is known or presumed to have occurred within the previous 7 days, or urine output < 0.5ml/kg/h for 6 hours.A range of factors with increased risk of developing CSA-AKI has been identified: patient-related, anesthesia-related, surgery-related, and cardiopulmonary bypass-related. The pathophysiology is multifactorial and not fully understood. Renal hypoperfusion, reperfusion injury, inflammation, oxidative stress, neurohormonal activation, nephrotoxins, and genetic polymorphisms are involved in the pathophysiology of CSA-AKI. In the vast majority of patients, AKI is a consequence of a decrease in glomerular filtration rate (GFR) due to hemodynamic disturbances.Renal blood flow is determined by the pressure gradient between inflow pressure (mean arterial pressure) and outflow pressure (central venous pressure or intra-abdominal pressure) 1 and by vascular resistance to flow (radius of afferent and efferent renal arteriole). Therefore, the injury may be due to reduced perfusion due to hypovolemia or reduced cardiac output and/or venous congestion. The management of these patients focuses on reversing renal hypoperfusion by improving cardiac output (administration of fluids and/or inotropes), hypotension (vasoconstrictors), congestion (diuretics, hemodialysis), and exposure to nephrotoxic agents. The traditional strategy of fluid administration to restore diuresis and renal function is often ineffective because it does not lead to improved renal perfusion. Moreover, the assessment of response to fluid administration is problematic with the use of central venous pressure and ultrasound assessment of the inferior vena cava, which are commonly used in clinical practice. Aggressive hydration can lead to volume overload, which is associated with peripheral organ dysfunction and increased mortality. Given that AKI due to systemic venous congestion is more common than hypovolemic AKI, the management of these patients should be individualized, taking into account the hemodynamic profile and the possibility of causing damage to peripheral organs. Transthoracic echocardiography is a non-invasive, cost-effective, bedside method for qualitative and quantitative assessment of myocardial function and hemodynamic profile. It can guide the administration of fluids and vasoactive drugs, detect complications, and contribute to etiological diagnosis in patients with renal injury. Its use can improve the outcome of patients with AKI hospitalized in the ICU. Ultrasound can also assess extravascular fluid in the lung even in subclinical congestion with high specificity, and it is useful for monitoring respiratory distress in patients with acute kidney injury. A new multiparametric ultrasound method for assessing splanchnic congestion is the Venous Excess Ultrasound Score (VExUS), the use of which is becoming established in specialized centers. It involves the combined assessment of the size and variation of the inferior vena cava, as well as Doppler assessment of blood flow in the liver (portal, hepatic veins) and kidney (renal vein and artery). VExUS findings can quantify splanchnic congestion even in cases where the results of traditional assessment methods are conflicting or even normal. Also, they are independently associated with acute kidney injury, both in hospitalized patients with heart failure and after cardiac surgery.The integration of multiparametric ultrasound assessment in clinical practice can identify reversible causes early, identify patients who will develop severe renal dysfunction, and recognize complications early. Therefore, it can guide clinical management from empirical approaches and supportive measures to an individualized approach to CSA-AKI in the perioperative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care |
| VEXUS | Other | Device: VEXUSGoal-directed fluid therapy according to VEXUS measurements to minimize AKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VEXUSGoal-directed fluid and drug therapy according to VEXUS measurements to minimize AKI | Device | VEXUS |
Primary outcome
Renal function
Time frame: Record Urea, Creatinine (preoperative value, enrollment day, post-operatively: 24hours-, 48hours-, 72hours-, 7th day-, at ICU discharge)
Renal function (Creatinine, [ΔCreatinine, %]) · Record Urea, Creatinine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VEXUS in people with Acute Kidney Injury and Cardiac Surgery Associated - Acute Kidney Injury, run by Onassis Cardiac Surgery Centre at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stavros Dimopoulos, PhD, EDIC (00306973956974, stdimop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function (time frame: Record Urea, Creatinine (preoperative value, enrollment day, post-operatively: 24hours-, 48hours-, 72hours-, 7th day-, at ICU discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.