VExUS in Ards Patients and Association with AKI (VEXAKI)

Evaluation of Venous Congestion Using Doppler and Venous Excess Ultrasound Score (VExUS) During Acute Respiratory Distress Syndrome and Its Association with Acute Kidney Injury

A single-center prospective observational study will be conducted with the aim of determining the prevalence of venous congestion during ARDS using venous Doppler and the VExUS score.

Study Overview

• Status: Recruiting
• Conditions: Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Detailed Description

Acute kidney injury (AKI) is common in patients with acute respiratory distress syndrome (ARDS) and is associated with higher mortality rates. Among the mechanisms underlying this AKI, venous congestion seems to be significant. However, methods for assessing congestion are limited and may be unreliable. The use of venous Doppler (inferior vena cava, suprahepatic veins, portal vein, and intrarenal veins) for grading the severity of congestion using the Venous Excess Ultrasound Score (VExUS) could potentially enable the earlier identification of ARDS patients with congestion.

A prospective observational monocenter study will be conducted with the objective to determine the prevalence of venous congestion during ARDS using venous Doppler and the VExUS score.

The primary outcome measure will be the proportion of patients with a VExUS score ≥ 1 within 48 hours following the initiation of invasive mechanical ventilation. The secondary objective is to evaluate the association of different VExUS grades with the occurrence of the composite endpoint of major kidney events at Day 30 (MAKE-30), defined as the occurrence of death, dependence on dialysis, or persistent elevation of creatinine ≥ 200% of baseline creatinine.

The study involves adult patients admitted to the intensive care unit with moderate to severe ARDS requiring mechanical ventilation for less than 48 hours and requiring hemodynamic support with catecholamines. Within 48 hours of initiating invasive mechanical ventilation, concurrently with the cardiac ultrasound, the multi-site venous Doppler will be performed. Demographical, clinical, and biological data will be prospectively collected. The multi-site venous Doppler will be repeated on Day 7 of mechanical ventilation initiation or during catecholamine weaning, depending on which event occurs first. Patients will be followed for the entire duration of their intensive care unit stay. For patients discharged alive from the intensive care unit, follow-up will continue until 3 months after discharge to assess the occurrence of chronic kidney disease following the initial hospitalization.

No other investigations are mandated by the protocol besides performing the multi-site venous Doppler.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Romain ARRESTIER, PHD; Phone Number: + 33 1 45 17 85 06; Email: romain.arrestier@aphp.fr
• Study Contact Backup: Name: Armand MEKONTSO DESSAP, MD; Phone Number: + 33 1 45 17 85 06; Email: romain.arrestier@aphp.fr

Study Locations

• France
  • Val de Marne
    • CRETEIL Cedex, Val de Marne, France, 94010
      • Recruiting
      • Armand MEKONTSO DESSAP
      • Contact: Armand MEKONTSO DESSAP; Email: armand.dessap@aphp.fr

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The study concerns adult patients hospitalized in intensive care for moderate to severe ARDS according to the Berlin definition, and requiring hemodynamic support with catecholamineEKG

Description

Inclusion Criteria:

• Patients ≥18 years old
• Moderate to severe ARDS according to the Berlin definition
• Requiring catecholamine support
• Undergoing invasive mechanical ventilation for less than 48 hours

Exclusion Criteria:

• Patients presenting with acute kidney injury KDIGO III requiring renal replacement therapy before the initial ultrasound evaluation
• Requirement for veno-venous or veno-arterial ECMO circulatory support before inclusion
• Patients with end-stage chronic kidney disease, on dialysis, and/or kidney transplant recipients
• History of Child C cirrhosis and/or liver transplantation and/or portal hypertension
• History of portal thrombosis
• Known history of pulmonary hypertension
• Pregnant women
• Patients under legal protection
• Patients who have expressed opposition to participating in the research

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of VExUS score ≥ 1 within 48 hours of invasive mechanical ventilation.	Quantification of the VExUS score from the measurement of the inferior vena cava size, an assessment of suprahepatic venous flow, portal venous flow and intra-renal venous.	48 hours, 7 days after mechanical ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of the composite endpoint of major kidney events at Day 30 (MAKE-30).	defined as death, dependence on dialysis, or persistence of a creatinine elevation ≥ 200% of baseline creatinine.	30 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): December 9, 2027
• Study Completion (Estimated): December 9, 2027

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: acute kidney injury; Acute respiratory distress syndrome; Venous Congestion
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Thoracic Injuries; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Lung Injury; Acute Lung Injury
• Other Study ID Numbers: APHP240897

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