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Not yet recruiting NCT07545252

Effect of Positive End-Expiratory Pressure Titration on Venous Excess Ultrasound Score and Renal Outcomes in Patients With Acute Respiratory Distress Syndrome

— Observational Acute Respiratory Distress Syndrome (ARDS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VExUS score.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome (ARDS). Basic parameters: 18 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study is a prospective observational cohort study conducted planned to include 40 patients with ARDS to assess the effect of different levels of PEEP titration on VExUS score and renal outcomes in patients with Acute Respiratory Distress Syndrome.

Detailed description

This study is a prospective observational cohort study conducted planned to include 40 patients with ARDS within 24 hours of onset and mechanically ventilated for more than 24 hours to assess the effect of different levels of PEEP titration on Venous Excess Ultrasound Score and renal outcomes in patients with Acute Respiratory Distress Syndrome.

Interventions

  • Other VExUS score
    The Venous Excess Ultrasound Score (VExUS) was calculated for each patient based on the assessment of systemic venous congestion using the following parameters: Inferior vena cava (IVC) diameter and respiratory collapsibility, Hepatic vein Doppler waveform, Portal vein Doppler pulsatility and Intrarenal venous Doppler pattern.

Primary outcome measures

  • VExUS score [Time frame: 3 days]
  • Development of acute kidney injury (AKI) [Time frame: 3 days]
Secondary outcome measures (3)
  • Requirement for renal replacement therapy (RRT) during ICU stay. [Time frame: 3 days]
  • Length of ICU stay [Time frame: 4 to 7 days]
  • ICU mortality [Time frame: 4 to 7 days]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years.
  • Diagnosis of ARDS according to the Berlin criteria.
  • Invasive mechanical ventilation ≥24 hours.
  • Requirement of PEEP ≥5 cmH₂O.

Exclusion criteria

  • Known end-stage renal disease on chronic dialysis.
  • History of renal transplantation.
  • Pregnancy.
  • Known severe tricuspid regurgitation.
  • Chronic liver disease with portal hypertension.
  • Poor ultrasound window precluding adequate venous Doppler assessment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07545252 · M869

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗