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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.
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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romain ARRESTIER, PHD | Contact | + 33 1 45 17 85 06 | romain.arrestier@aphp.fr | |
| Armand MEKONTSO DESSAP, MD | Contact | + 33 1 45 17 85 06 | romain.arrestier@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Armand MEKONTSO DESSAP | Recruiting | Créteil | Val de Marne | 94010 | France |
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| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D012128 | Respiratory Distress Syndrome |
| D058186 | Acute Kidney Injury |
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| D051437 |
| Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |