An interventional study of VeXUS score guided fluid management strategy and Usual care in Acute Kidney Injury, Cardiac Surgery and Venous Congestion, sponsored by Hospices Civils de Lyon. Recruiting at 2 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: VeXUS score guided fluid management strategy
Fluid management: * Usual care * at the discretion of the attending physician
Other: Usual care
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.
Fluid management will be at the discretion of attending physician, who will be blinded to the patient's VeXUS score status.
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.
Time frame: 48 hours after the inclusion
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.
Time frame: 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.
Time frame: 48 hours after the inclusion
Venous congestion prevalence
Proportion of patients with VeXUS score \>1 at the inclusion
Time frame: Day 1
Haemodynamic instability occurrence
Occurrence of Mottling score\>1 or capillary refill time\>3s
Time frame: 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
Time frame: Day 2
Persistent acute Kidney Injury occurrence
Description and comparison of the persistent acute Kidney Injury occurrence in the 2 groups
Time frame: 48 hours after the inclusion
Use of Renal Replacement Therapy (RRT) occurrence
Description and comparison of the RRT requirement in the 2 groups
Time frame: 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.
Time frame: 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.
Time frame: Day 30 (D30)
Plan to share: No
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