Assessing venous congestion in ARDS patients using ultrasound
Evaluation of Venous Congestion Using Doppler and Venous Excess Ultrasound Score (VExUS) During Acute Respiratory Distress Syndrome and Its Association with Acute Kidney Injury
This study is testing if using ultrasound can help find out how common venous congestion is in patients with acute respiratory distress syndrome who are on mechanical ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil, Val de Marne) |
| Trial ID | NCT06805409 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the prevalence of venous congestion in patients with acute respiratory distress syndrome (ARDS) using venous Doppler ultrasound and the Venous Excess Ultrasound Score (VExUS). It will involve adult patients admitted to the intensive care unit who require mechanical ventilation and catecholamine support. The primary outcome will measure the proportion of patients with a VExUS score of 1 or higher within 48 hours of starting invasive mechanical ventilation, while secondary outcomes will evaluate the association of VExUS grades with major kidney events at 30 days. The study seeks to improve the understanding of venous congestion's role in acute kidney injury among ARDS patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with moderate to severe ARDS requiring mechanical ventilation and catecholamine support.
Not a fit: Patients with acute kidney injury requiring dialysis, end-stage chronic kidney disease, or those with significant liver or pulmonary conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification and management of venous congestion in ARDS patients, potentially reducing the risk of acute kidney injury.
How similar studies have performed: While the use of VExUS in this context is relatively novel, similar studies have shown promise in assessing venous congestion and its implications in critical care settings.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Créteil, Val de Marne
- Armand MEKONTSO DESSAP — Créteil, Val de Marne, France (Recruiting)
Study contacts
- Study coordinator: Romain ARRESTIER, PHD
- Email: romain.arrestier@aphp.fr
- Phone: + 33 1 45 17 85 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.