Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery

Civil Hospices of Lyon

Status: Enrolling

Conditions: Cardiac Surgery; Venous Congestion; Acute Kidney Injury; Hemodynamic Stability

Treatments: Other: Usual care; Other: VeXUS score guided fluid management strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06251713

69HCL23_0891

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

VeXUS score guided fluid management

Experimental group

Description:

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

Treatment:

Other: VeXUS score guided fluid management strategy

Usual care

Other group

Description:

Fluid management: * Usual care * at the discretion of the attending physician

Treatment:

Other: Usual care