VExUS in Ards Patients and Association with AKI

NCT06805409 | Recruiting

• 1 other identifier: APHP240897
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Keywords

Acute respiratory distress syndrome; acute kidney injury; Venous Congestion

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Occurrence of the composite endpoint of major kidney events at Day 30 (MAKE-30).

  30 days

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients presenting with acute kidney injury KDIGO III requiring renal replacement therapy before the initial ultrasound evaluation
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Armand MEKONTSO DESSAP

Créteil, Val de Marne, 94010, France

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome; Acute Kidney Injury; Hyperemia

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: February 3, 2025
• Study Start: December 2, 2024
• Primary Completion (Estimated): December 9, 2027
• Study Completion (Estimated): December 9, 2027
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

FR (1)