Armand MEKONTSO DESSAP
Créteil, Val de Marne, 94010, France
Location status: Recruiting
NCT Number: NCT06805409
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Créteil, Val de Marne, 94010, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 48 hours, 7 days after 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: 30 days
defined as death, dependence on dialysis, or persistence of a creatinine elevation ≥ 200% of baseline creatinine.
Contact information is provided by the study sponsor or research team.
Armand MEKONTSO DESSAP, MD
CONTACT
Romain ARRESTIER, PHD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Evaluation of Venous Congestion Using Doppler and Venous Excess Ultrasound Score (VExUS) During Acute Respiratory Distress Syndrome and Its Association with Acute Kidney Injury
Acronym: VEXAKI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06513949
Acute Lung Injury, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Seattle, Washington, United States
View Trial DetailsNCT06123962
Acute Lung Injury, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Beijing, China
View Trial DetailsNCT05002478
Acute Lung Injury, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Vienna, Austria
View Trial DetailsNCT04935697
Acute Lung Injury, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Pittsburgh, Pennsylvania, United States
View Trial Details