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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Cardiac Surgery; Venous Congestion; Hemodynamic Stability
• Intervention / Treatment: Other: VeXUS score guided fluid management strategy; Other: Usual care

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Luc Fellahi, MD; Phone Number: +334 72 31 89 44; Email: jean-luc.fellahi@chu-lyon.fr
• Study Contact Backup: Name: RUSTE Martin, MD; Phone Number: +334 72 11 89 56; Email: martin.ruste@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Not yet recruiting
    • Hôpital Louis Pradel, Groupement Hospitalier Est, Hospices Civils de Lyon
    • Contact: Fellahi Jean-Luc, MD; Phone Number: +334 72 31 89 44; Email: jean-luc.fellahi@chu-lyon.fr
  • Bron, France
    • Recruiting
    • Hôpital cardiologique Louis Pradel
    • Contact: FELLAHI Jean-Luc, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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.
Other: Usual care; Fluid management: Usual care; at the discretion of the attending physician	Other: Usual care; Fluid management will be at the discretion of attending physician, who will be blinded to the patient's VeXUS score status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours after the inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	48 hours after the inclusion
Venous congestion prevalence	Proportion of patients with VeXUS score >1 at the inclusion	Day 1
Haemodynamic instability occurrence	Occurrence of Mottling score>1 or capillary refill time>3s	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	Day 2
Persistent acute Kidney Injury occurrence	Description and comparison of the persistent acute Kidney Injury occurrence in the 2 groups	48 hours after the inclusion
Use of Renal Replacement Therapy (RRT) occurrence	Description and comparison of the RRT requirement in the 2 groups	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.	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.	Day 30 (D30)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Acute kidney injury; Cardiac surgery; diuretic; Venous Congestion; fluid removal; VeXUS score
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Wounds and Injuries; Hyperemia
• Other Study ID Numbers: 69HCL23_0891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No