Actively Recruiting
Evaluation of Venous Congestion Using Doppler and Venous Excess Ultrasound Score (VExUS) During Acute Respiratory Distress Syndrome and Its Association with Acute Kidney Injury
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-02-03
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to determine how common venous congestion is in adults with acute respiratory distress syndrome (ARDS) using venous Doppler ultrasound and the Venous Excess Ultrasound Score (VExUS). Acute kidney injury (AKI) often occurs in ARDS patients and is linked to higher death rates. Venous congestion may play a key role in this, but current methods to assess it may be unreliable. The study seeks to identify congestion early in patients needing mechanical ventilation and catecholamine support. Participants are adults with moderate to severe ARDS admitted to the intensive care unit and on invasive mechanical ventilation for less than 48 hours. Within 48 hours of starting ventilation, they will receive a multi-site venous Doppler ultrasound alongside cardiac ultrasound to assess venous congestion. This Doppler evaluation will be repeated on Day 7 of ventilation or during catecholamine weaning, whichever comes first. The study does not require any other investigations. Patients will be followed throughout their ICU stay and for three months after discharge if they survive, to monitor for chronic kidney disease after hospitalization. Researchers will collect demographic, clinical, and biological data to evaluate the proportion of patients with a VExUS score of 1 or higher within 48 hours of ventilation. They will also study how different VExUS grades relate to major kidney events within 30 days, including death, dialysis dependence, or significant creatinine increase.
CONDITIONS
Brief Title
VExUS in Ards Patients and Association with AKI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years old or older
- Moderate to severe ARDS according to the Berlin definition
- Requiring catecholamine support
- Undergoing invasive mechanical ventilation for less than 48 hours
You will not qualify if you...
- Acute kidney injury KDIGO III requiring renal replacement therapy before ultrasound evaluation
- Need for veno-venous or veno-arterial ECMO support before inclusion
- End-stage chronic kidney disease, dialysis, or kidney transplant recipients
- History of Child C cirrhosis, liver transplantation, or portal hypertension
- History of portal thrombosis
- Known pulmonary hypertension
- Pregnant women
- Patients under legal protection
- Patients who oppose participation in the research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 48 hours of invasive mechanical ventilation initiation
Participants undergo multi-site venous Doppler ultrasound to assess venous congestion using the Venous Excess Ultrasound Score (VExUS) within 48 hours of starting invasive mechanical ventilation.
1 visit (in-person)
Duration - Up to ICU discharge
Participants have a repeated multi-site venous Doppler ultrasound on Day 7 of mechanical ventilation initiation or during catecholamine weaning, whichever occurs first, along with collection of clinical and biological data during their ICU stay.
1 to 2 visits depending on ventilation and catecholamine weaning timing
Duration - Up to 3 months after ICU discharge
Participants discharged alive from the intensive care unit are followed for up to 3 months after discharge to assess kidney function and the occurrence of chronic kidney disease.
Follow-up visits as scheduled during the 3-month period
Trial Site Locations
Total: 1 location
1
Armand MEKONTSO DESSAP
Créteil, Val de Marne, France, 94010
Actively Recruiting
Research Team
R
Romain ARRESTIER, PHD
A
Armand MEKONTSO DESSAP, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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