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NCT Number: NCT06251713

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

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.

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Key information

Conditions

Acute Kidney Injury Cardiac Surgery Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodynamic Stability Hyperemia Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases Venous Congestion

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VeXUS score guided fluid management strategy

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

Other

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

Primary outcomes

  1. Randomized controlled study feasibility

    Time frame: 48 hours after the inclusion

    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.

Secondary outcomes

  1. Description of the "standard practice" group

    Time frame: 48 hours after the inclusion

    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.

  2. Description of deviations from the protocol in the "intervention" group"

    Time frame: 48 hours after the inclusion

    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.

  3. Venous congestion prevalence

    Time frame: Day 1

    Proportion of patients with VeXUS score >1 at the inclusion

  4. Haemodynamic instability occurrence

    Time frame: Between inclusion and Hour 48 (H48)

    Occurrence of Mottling score>1 or capillary refill time>3s

  5. Severe metabolic disturbance occurrence

    Time frame: Day 2

    Occurrence of serum potassium <3mmol/L, serum sodium >150 mmol/L, arterial pH>7.55 with HCO3->40mmol/L

  6. Persistent acute Kidney Injury occurrence

    Time frame: 48 hours after the inclusion

    Description and comparison of the persistent acute Kidney Injury occurrence in the 2 groups

  7. Use of Renal Replacement Therapy (RRT) occurrence

    Time frame: Day 30 (D30)

    Description and comparison of the RRT requirement in the 2 groups

  8. Renal adverse events

    Time frame: Day 30 (D30)

    Description and comparison of the 2 groups for the composite criteria : death or Renal Replacement therapy dependence or creatinine > 200% baseline creatinine.

  9. Acute kidney disease occurrence

    Time frame: Day 30 (D30)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Luc Fellahi, MD

CONTACT

[email protected]

+334 72 31 89 44

RUSTE Martin, MD

CONTACT

[email protected]

+334 72 11 89 56

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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.

Acronym: VeXUS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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