NCT07452952

Brief Summary

The main objective is to assess the effect of increased PEEP on echo-Doppler venous congestion in ARDS patients at two PEEP levels, by grading congestion in each venous flow (suprahepatic, renal, portal) as "absent," "moderate," or "severe," and also calculating the VExUS score.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
18mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Nov 2027

First Submitted

Initial submission to the registry

January 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

March 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

January 23, 2026

Last Update Submit

February 27, 2026

Conditions

Mechanical VentilationAcute Respiratory Distress Syndrome (ARDS)

Keywords

ARDSvenous congestionVEXUSPEPright heart failureacute cor pulmonale

Outcome Measures

Primary Outcomes (1)

  • Evolution of the level of venous congestion evaluated on the different abdominal Doppler venous flows (portal, suprahepatic and renal venous Doppler) and on the VExUS score between the different levels of PEEP (high and low)

    The evolution of venous congestion between two PEEP levels (high and low), assessed by analyzing each Doppler flow individually (hepatic veins, renal interlobar veins, and portal vein) and grading them as 'absent,' 'moderate,' or 'severe,' as well as by the VExUS score, graded from 0 to 3.

    Baseline

Secondary Outcomes (8)

  • In patients with a pulmonary artery catheter: evolution between venous congestion in abdominal venous flow and the VExUS score with right heart pressures (systolic, diastolic and mean pulmonary arterial pressure at D1, D3-D5 and D6-D8)

    From Baseline to day 8

  • Evaluate the evolution of venous congestion (VExUS score) according to the PEEP level over time (D1, D3-D5 and D6-D8) for each patient individually

    From baseline to Day 8

  • Evaluate the evolution of venous congestion in abdominal venous flows and the VExUS score according to PEEP level

    From baseline to Day 8

  • Incidence of acute renal failure at day 28 in patients with markers of significant venous congestion

    From baseline to day 28

  • Incidence of renal replacement therapy on day 28 in patients with markers of significant venous congestion

    From baseline to Day 28

  • +3 more secondary outcomes

Study Arms (1)

ARDS (Acute respiratory distress syndrome)

Patient with ARDS who are placed on mechanical ventilation

Other: Non-interventionnal study

Interventions

Non-interventionnal studyOTHER

Non-interventionnal study

ARDS (Acute respiratory distress syndrome)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients hospitalized in the Medical Intensive Care and Hyperbaric Medicine Unit of Angers University Hospital, receiving mechanical ventilation in assist-control mode (A/C ventilation), and presenting with ARDS

You may qualify if:

  • Patients hospitalized in the Medical Intensive Care and Hyperbaric Medicine Unit of Angers University Hospital, receiving mechanical ventilation in assist-control mode (A/C ventilation), and presenting with ARDS as defined by the following criteria (1):
  • Hypoxemia with a PaO₂ (mmHg)/FiO₂ (0.21 to 1.0) ratio \<300 mmHg with a positive end-expiratory pressure (PEEP) ≥5 cmH₂O;
  • Pulmonary edema not fully explained by cardiac failure or fluid overload;
  • Presence of bilateral pulmonary opacities on chest imaging not fully explained by pleural effusions, atelectasis, or pulmonary nodules.

You may not qualify if:

  • Minor patient (\<18 years old)
  • ECMO (Extracorporeal Membrane Oxygenation)
  • Hemodynamic instability (mean arterial pressure \<60 mmHg)
  • Respiratory instability (SpO₂ \<90% under FiO₂ \>90%)
  • Severe organic tricuspid regurgitation
  • Congenital heart disease
  • Pneumothorax
  • Renal or hepatic transplant recipient
  • Liver cirrhosis Child-Pugh C
  • Portal vein thrombosis or Budd-Chiari syndrom
  • Abdominal compartment syndrome documented by intra-abdominal pressure ≥20 mmHg
  • Pregnant, breastfeeding, or peripartum women
  • Persons deprived of liberty by judicial or administrative decision
  • Persons subject to compulsory psychiatric care
  • Persons under legal protective measures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Angers

Angers, France

Location

Related Publications (3)

  • Li G, Malinchoc M, Cartin-Ceba R, Venkata CV, Kor DJ, Peters SG, Hubmayr RD, Gajic O. Eight-year trend of acute respiratory distress syndrome: a population-based study in Olmsted County, Minnesota. Am J Respir Crit Care Med. 2011 Jan 1;183(1):59-66. doi: 10.1164/rccm.201003-0436OC. Epub 2010 Aug 6.

    PMID: 20693377BACKGROUND

  • Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

    PMID: 26903337BACKGROUND

  • Grasselli G, Calfee CS, Camporota L, Poole D, Amato MBP, Antonelli M, Arabi YM, Baroncelli F, Beitler JR, Bellani G, Bellingan G, Blackwood B, Bos LDJ, Brochard L, Brodie D, Burns KEA, Combes A, D'Arrigo S, De Backer D, Demoule A, Einav S, Fan E, Ferguson ND, Frat JP, Gattinoni L, Guerin C, Herridge MS, Hodgson C, Hough CL, Jaber S, Juffermans NP, Karagiannidis C, Kesecioglu J, Kwizera A, Laffey JG, Mancebo J, Matthay MA, McAuley DF, Mercat A, Meyer NJ, Moss M, Munshi L, Myatra SN, Ng Gong M, Papazian L, Patel BK, Pellegrini M, Perner A, Pesenti A, Piquilloud L, Qiu H, Ranieri MV, Riviello E, Slutsky AS, Stapleton RD, Summers C, Thompson TB, Valente Barbas CS, Villar J, Ware LB, Weiss B, Zampieri FG, Azoulay E, Cecconi M; European Society of Intensive Care Medicine Taskforce on ARDS. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies. Intensive Care Med. 2023 Jul;49(7):727-759. doi: 10.1007/s00134-023-07050-7. Epub 2023 Jun 16.

    PMID: 37326646BACKGROUND

MeSH Terms

Conditions

Respiratory Distress SyndromeHyperemiaHeart Failure

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersVascular DiseasesCardiovascular DiseasesHeart Diseases

Study Officials

  • Pierre ASFAR

    University Hospital of Angers

    STUDY CHAIR

Central Study Contacts

Pierre ASFAR

CONTACT

241353637pierre.asfar@chu-angers.fr

Pierre ASFAR

CONTACT

pierre.asfar@chu-angers.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2026

First Posted

March 5, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-01

Locations

FR(1)