An observational study in Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
994 studies on the registry are indexed under Acute Lung Injury; 156 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 368 observational studies indexed under Acute Lung Injury.
Browse Acute Lung Injury studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
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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
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Exclusion Criteria:
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.
Time frame: 48 hours, 7 days after mechanical ventilation
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.
Time frame: 30 days
Started Dec 2024 (actual). Primary completion is estimated for Dec 2027, 36 months after the start.
Of 162 non-industry observational studies under Acute Lung Injury, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 36. This study's planned 36 months is above that.
Counting every sponsor, half of 171 studies reached it within 20 months; a quarter within 9 and three quarters within 36.
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