NCT06251713 Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery
| NCT ID | NCT06251713 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-07-31 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06251713 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06251713 currently recruiting?
Yes, NCT06251713 is actively recruiting participants. Contact the research team at jean-luc.fellahi@chu-lyon.fr for enrollment information.
Where is the NCT06251713 trial being conducted?
This trial is being conducted at Bron, France, Bron, France.
Who is sponsoring the NCT06251713 clinical trial?
NCT06251713 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 40 participants.
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