NCT06805409

VExUS in Ards Patients and Association with AKI

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Timeline

• Start date: 2024-12-02
• Primary completion: 2027-12-09
• Completion: 2027-12-09
• First posted: 2025-02-03
• Last updated: 2025-02-03

Locations

1 site across 1 country: France