Acute Kidney InjuryVeXUSNCT06251713
Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery
A study testing VeXUS score guided fluid management strategy in people with Acute Kidney Injury and Cardiac Surgery, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Acute kidney injury affects more than 30% of patients after cardiac surgery, and is associated with an excess in mortality. There is a clinical continuum between acute kidney injury (transient if <48h, persistent if >48h), the development of acute kidney and chronic renal failure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury, Cardiac Surgery, Venous Congestion
- What is being tested?
- VeXUS score guided fluid management strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Jul 2024to Jul 2027
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intensive care unit admission within 72 hours of cardiac surgery with extracorporeal circulation
- Acute kidney injury defined by KDIGO criteria
- Vasoactive inotropic score <45 and capillary refill time <3s
- Informed written consent
Who cannot join
- Hypokalaemia <3.5mmol/L
- Hyponatremia<125mmol/L
- Hypernatremia >145mmol/L
- Metabolic alkalosis with pH >7.50
- Impossibility to measure capillary refill time
- Chronic liver disease
Show all 18Show fewer
- Cirrhosis with portal hypertension
- Known thrombus of the inferior vena cava
- Mechanical circulatory assistance (ECMO or mono left ventricular assistance)
- Severe pre-operative chronic kidney disease (GFR < 30mL/min/1.73m2)
- Need for renal replacement therapy anticipated by the attending physician within 24 hours
- Known hypersensitivity to Furosemide and/or hydrochlorothiazide
- Severe allergy to wheat
- Patient already included in another interventional study with an exclusion period still in progress
- Pregnant, breast-feeding or women of childbearing age without suitable contraception
- Patients under guardianship, curatorship or safeguard of justice
- Patients under psychiatric care
- Patients not affiliated to a social security scheme or beneficiaries of a similar scheme
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Hôpital Louis Pradel, Groupement Hospitalier Est, Hospices Civils de Lyon
Bron, Bron, 69500
Fellahi Jean-Luc, MD, +334 72 31 89 44, jean-luc.fellahi@chu-lyon.fr
- Recruiting
Hopital cardiologique Louis Pradel
Bron
FELLAHI Jean-Luc, MD
About this study
Official title: Feasibility of a Randomised Trial Comparing a Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery: a Pilot Randomised Trial.
Acute kidney injury affects more than 30% of patients after cardiac surgery, and is associated with an excess in mortality. There is a clinical continuum between acute kidney injury (transient if <48h, persistent if >48h), the development of acute kidney and chronic renal failure. Each of these entities characterising renal recovery is associated with an increase in long-term morbidity and mortality. Fluid management in patients with acute kidney injury is challenging, as both hypovolaemia and hypervolaemia are detrimental. Venous congestion (reflecting intravascular hypervolaemia), is a well-established haemodynamic factor contributing to acute kidney injury after cardiac surgery. An ultrasound score, based on the venous doppler pattern explored in intra-abdominal organs, has recently been developed and is a better predictor of acute kidney injury than central venous pressure. Whether using the VeXUS score to guide fluid removal in haemodynamically stabilised patients could promote renal recovery after acute kidney injury remains to be investigated.
Before designing a large randomised trial to test such a strategy, its feasibility in a pilot randomised trial is assessed.
- Being tested
- VeXUS score guided fluid management strategy, Usual care
- Keywords
- Acute kidney injury, Cardiac surgery, Venous Congestion, VeXUS score, diuretic, fluid removal
- Medical subject headings
- Acute Kidney Injury, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeXUS score guided fluid management strategyOther
During the first 3 postoperative days, the VeXUS score is estimated daily by ultrasound. If VeXUS score >1, diuretic-induced fluid removal will be administred (target diuresis: 2-4mL/kg/h). The diuretic administration protocol is derived from the CARRESS HF study: bolus followed by a continuous administration of Furosemide with thiazide added based on preoperative diuretic administration status.
To prevent hypokalaemia and dysnatremia, a protocol for potassium supplementation and intravenous administration of chloride serum or hypotonic perfusion is planned.
Fluid removal will be suspended if severe metabolic disturbance (pH>7.55 with HCO3->40mmol/L or serum K+ <3 mmol/L or serum Na>150 mmol/L) or haemodynamic instability (hypoperfusion) with fluid responsiveness occurs. Regardless of the VeXUS score, diuretics will be introduced in case of pulmonary oedema.
Haemodynamic status will be every 12 hours to detect side effects attributable to diuretic-induced fluid removal.
Usual careOther
Fluid management will be at the discretion of attending physician, who will be blinded to the patient's VeXUS score status.
| Study group | Role | What they receive |
|---|---|---|
| VeXUS score guided fluid management | Experimental | Fluid management:
* Restrictive intake
* Diuretic-induced fluid removal aiming for a diuresis of 2-4mL/Kg/h if VeXUS score > 1
* During 24 to 48 hours Receives: Other: VeXUS score guided fluid management strategy |
| Usual care | Other | Fluid management:
* Usual care
* at the discretion of the attending physician Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Randomized controlled study feasibility
Percentage of patients recruited without deviations from the protocol (number of patients included per month) at the end of the recruitment and follow-up period, i.e. the number of patients who received the full initial treatment (48 hours) in accordance with the interventional protocol out of the number of patients eligible for the study.
Measured: 48 hours after the inclusion
Secondary outcomes (9)
Description of the "standard practice" group
The standard practice groupe will be describe. The description will be based on the number of patients concerned by the administration of diuretics, molecule and dosage used, reason for the administration of diuretics, cumulative fluid balance.
Measured: 48 hours after the inclusion
Description of deviations from the protocol in the "intervention" group"
To evaluation de faisability of the trial, the description of the deviations occurring in the intervention group will be based on the number of patients concerned, nature of the deviation from the protocol, cumulative fluid balance.
Measured: 48 hours after the inclusion
Venous congestion prevalence
Proportion of patients with VeXUS score >1 at the inclusion
Measured: Day 1
Haemodynamic instability occurrence
Occurrence of Mottling score>1 or capillary refill time>3s
Measured: Between inclusion and Hour 48 (H48)
Severe metabolic disturbance occurrence
Occurrence of serum potassium <3mmol/L, serum sodium >150 mmol/L, arterial pH>7.55 with HCO3->40mmol/L
Measured: Day 2
Persistent acute Kidney Injury occurrence
Description and comparison of the persistent acute Kidney Injury occurrence in the 2 groups
Measured: 48 hours after the inclusion
Use of Renal Replacement Therapy (RRT) occurrence
Description and comparison of the RRT requirement in the 2 groups
Measured: Day 30 (D30)
Renal adverse events
Description and comparison of the 2 groups for the composite criteria : death or Renal Replacement therapy dependence or creatinine > 200% baseline creatinine.
Measured: Day 30 (D30)
Acute kidney disease occurrence
Description and comparison of the 2 groups for the composite criteria : albuminuria or GFR <60mL/min/1.73m or decrease of more than 35% in GFR.
Measured: Day 30 (D30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start31 Jul 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251713
- Sponsor's protocol ID
- 69HCL23_0891
- Acronym
- VeXUS
- Status last verified
- Jul 2026
- First submitted
- 15 Jan 2024
- Last updated
- 24 Jul 2026
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Randomised Trial Comparing a Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery: a Pilot Randomised Trial.
- ClinicalTrials.gov ID
- NCT06251713
- Acronym / sponsor ID
- VeXUS / 69HCL23_0891
- Keywords
- Acute kidney injury, Cardiac surgery, Venous Congestion, VeXUS score, diuretic, fluid removal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Feb 2024 (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.
Acute kidney injury affects more than 30% of patients after cardiac surgery, and is associated with an excess in mortality. There is a clinical continuum between acute kidney injury (transient if <48h, persistent if >48h), the development of acute kidney and chronic renal failure. Each of these entities characterising renal recovery is associated with an increase in long-term morbidity and mortality. Fluid management in patients with acute kidney injury is challenging, as both hypovolaemia and hypervolaemia are detrimental. Venous congestion (reflecting intravascular hypervolaemia), is a well-established haemodynamic factor contributing to acute kidney injury after cardiac surgery. An ultrasound score, based on the venous doppler pattern explored in intra-abdominal organs, has recently been developed and is a better predictor of acute kidney injury than central venous pressure. Whether using the VeXUS score to guide fluid removal in haemodynamically stabilised patients could promote renal recovery after acute kidney injury remains to be investigated.
Before designing a large randomised trial to test such a strategy, its feasibility in a pilot randomised trial is assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VeXUS score guided fluid management | Experimental | Other: VeXUS score guided fluid management strategyFluid management: * Restrictive intake * Diuretic-induced fluid removal aiming for a diuresis of 2-4mL/Kg/h if VeXUS score > 1 * During 24 to 48 hours |
| Usual care | Other | Other: Usual careFluid management: * Usual care * at the discretion of the attending physician |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Intensive care unit admission within 72 hours of cardiac surgery with extracorporeal circulation
- Acute kidney injury defined by KDIGO criteria
- Vasoactive inotropic score <45 and capillary refill time <3s
- Informed written consent
Key exclusion criteria (18 listed)
- Hypokalaemia <3.5mmol/L
- Hyponatremia<125mmol/L
- Hypernatremia >145mmol/L
- Metabolic alkalosis with pH >7.50
- Impossibility to measure capillary refill time
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 |
|---|---|---|
| VeXUS score guided fluid management strategyDuring the first 3 postoperative days, the VeXUS score is estimated daily by ultrasound. If VeXUS score >1, diuretic-induced fluid removal will be administred (target diuresis: 2-4mL/kg/h). The diuretic administration protocol is derived from the CARRESS HF study: bolus followed by a continuous administration of Furosemide with thiazide added based on preoperative diuretic administration status. To prevent hypokalaemia and dysnatremia, a protocol for potassium supplementation and intravenous administration of chloride serum or hypotonic perfusion is planned. Fluid removal will be suspended if severe metabolic disturbance (pH>7.55 with HCO3->40mmol/L or serum K+ <3 mmol/L or serum Na>150 mmol/L) or haemodynamic instability (hypoperfusion) with fluid responsiveness occurs. Regardless of the VeXUS score, diuretics will be introduced in case of pulmonary oedema. Haemodynamic status will be every 12 hours to detect side effects attributable to diuretic-induced fluid removal. | Other | VeXUS score guided fluid management |
| Usual careFluid management will be at the discretion of attending physician, who will be blinded to the patient's VeXUS score status. | Other | Usual care |
Primary outcome
Randomized controlled study feasibility
Time frame: 48 hours after the inclusion
Percentage of patients recruited without deviations from the protocol (number of patients included per month) at the end of the recruitment and follow-up period, i.e. the number of patients who received the full initial treatment (48 hours) in accordance with the interventional protocol out of the number of patients eligible for the study.
9 secondary outcomes
Description of the "standard practice" group
Time frame: 48 hours after the inclusion
Description of deviations from the protocol in the "intervention" group"
Time frame: 48 hours after the inclusion
Venous congestion prevalence
Time frame: Day 1
Haemodynamic instability occurrence
Time frame: Between inclusion and Hour 48 (H48)
Severe metabolic disturbance occurrence
Time frame: Day 2
Persistent acute Kidney Injury occurrence
Time frame: 48 hours after the inclusion
Use of Renal Replacement Therapy (RRT) occurrence
Time frame: Day 30 (D30)
Renal adverse events
Time frame: Day 30 (D30)
Acute kidney disease occurrence
Time frame: Day 30 (D30)
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 24 Jul 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VeXUS score guided fluid management strategy in people with Acute Kidney Injury and Cardiac Surgery, run by Hospices Civils de Lyon at 2 sites in France.
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 4 inclusion and 18 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Jean-Luc Fellahi, MD (+334 72 31 89 44, jean-luc.fellahi@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Randomized controlled study feasibility (time frame: 48 hours after the inclusion). 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 24 Jul 2026.