Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)VEXAKINCT06805409
VExUS in Ards Patients and Association with AKI
An observational study of Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2024to 9 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients presenting with acute kidney injury KDIGO III requiring renal replacement therapy before the initial ultrasound evaluation
- Requirement for veno-venous or veno-arterial ECMO circulatory support before inclusion
- 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
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- Pregnant women
- Patients under legal protection
- Patients who have expressed opposition to participating in the research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Armand MEKONTSO DESSAP
Créteil, Val de Marne, 94010
Armand MEKONTSO DESSAP, armand.dessap@aphp.fr
About this study
Official title: Evaluation of Venous Congestion Using Doppler and Venous Excess Ultrasound Score (VExUS) During Acute Respiratory Distress Syndrome and Its Association with Acute Kidney Injury
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.
Read the detailed description
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.
- Keywords
- Acute respiratory distress syndrome, acute kidney injury, Venous Congestion
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Acute Kidney Injury, Hyperemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours, 7 days after mechanical ventilation
Secondary outcomes (1)
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start2 Dec 2024
- Primary completion9 Dec 2027 (estimated)
- Study completion9 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805409
- Sponsor's protocol ID
- APHP240897
- Acronym
- VEXAKI
- Status last verified
- Jan 2025
- First submitted
- 5 Nov 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Venous Congestion Using Doppler and Venous Excess Ultrasound Score (VExUS) During Acute Respiratory Distress Syndrome and Its Association with Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06805409
- Acronym / sponsor ID
- VEXAKI / APHP240897
- Keywords
- Acute respiratory distress syndrome, acute kidney injury, Venous Congestion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 9 Dec 2027 (estimated)
- Study completion
- 9 Dec 2027 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Patients presenting with acute kidney injury KDIGO III requiring renal replacement therapy before the initial ultrasound evaluation
- Requirement for veno-venous or veno-arterial ECMO circulatory support before inclusion
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of VExUS score ≥ 1 within 48 hours of invasive mechanical ventilation.
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.
1 secondary outcome
Occurrence of the composite endpoint of major kidney events at Day 30 (MAKE-30).
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain ARRESTIER, PHD (+ 33 1 45 17 85 06, romain.arrestier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of VExUS score ≥ 1 within 48 hours of invasive mechanical ventilation. (time frame: 48 hours, 7 days after mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.