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

NCT06251713 | Recruiting

• 1 other identifier: 69HCL23_0891
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

Acute kidney injury; Cardiac surgery; Venous Congestion; VeXUS score; diuretic; fluid removal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Description of the "standard practice" group

  48 hours after the inclusion

• Description of deviations from the protocol in the "intervention" group"

  48 hours after the inclusion

• Venous congestion prevalence

  Day 1

• Haemodynamic instability occurrence

  Between inclusion and Hour 48 (H48)

• Severe metabolic disturbance occurrence

  Day 2

Study Arms (2)

VeXUS score guided fluid management

EXPERIMENTAL

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

Usual care

OTHER

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

Other: Usual care

Interventions

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.

VeXUS score guided fluid management

Usual care OTHER

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

Usual care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant, breast-feeding or women of childbearing age without suitable contraception
• Patients under guardianship, curatorship or safeguard of justice

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

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

Bron, Bron, 69500, France

NOT YET RECRUITING

Hopital cardiologique Louis Pradel

Bron, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Hyperemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jean-Luc Fellahi, MD

CONTACT

+334 72 31 89 44; jean-luc.fellahi@chu-lyon.fr

RUSTE Martin, MD

CONTACT

+334 72 11 89 56; martin.ruste@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 9, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)