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

NCT ID: NCT06251713

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

VeXUS score guided fluid management

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

Group Type: EXPERIMENTAL

VeXUS score guided fluid management strategy

Intervention Type: OTHER

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 care

Fluid management:

• Usual care
• at the discretion of the attending physician

Group Type: OTHER

Usual care

Intervention Type: OTHER

Fluid management will be at the discretion of attending physician, who will be blinded to the patient's VeXUS score status.

Interventions

VeXUS score guided fluid management strategy

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.

Intervention Type: OTHER

Usual care

Fluid management will be at the discretion of attending physician, who will be blinded to the patient's VeXUS score status.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Louis Pradel, Groupement Hospitalier Est, Hospices Civils de Lyon

Bron, Bron, France

Site Status: NOT_YET_RECRUITING

Hopital cardiologique Louis Pradel

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jean-Luc Fellahi, MD

Role: CONTACT

jean-luc.fellahi@chu-lyon.fr

+334 72 31 89 44

RUSTE Martin, MD

Role: CONTACT

martin.ruste@chu-lyon.fr

+334 72 11 89 56

Facility Contacts

Fellahi Jean-Luc, MD

Role: primary

jean-luc.fellahi@chu-lyon.fr

+334 72 31 89 44

FELLAHI Jean-Luc, MD

Role: primary

Other Identifiers

69HCL23_0891

Identifier Type: -

Identifier Source: org_study_id