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NCT Number: NCT07545252

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

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.

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Key information

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VExUS score

Other

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 outcomes

  1. VExUS score

    Time frame: 3 days

    Change in VExUS score in relation to different PEEP levels in mechanically ventilated patients with ARDS.

  2. Development of acute kidney injury (AKI)

    Time frame: 3 days

    Development of acute kidney injury (AKI), defined and staged according to the KDIGO criteria: increase in serum creatinine by ≥0.3 mg/dL within 48 hours, or ≥1.5 times baseline within 7 days, or urine output <0.5 mL/kg/hour for 6 hours.

Secondary outcomes

  1. Requirement for renal replacement therapy (RRT) during ICU stay.

    Time frame: 3 days

    Requirement for renal replacement therapy (RRT) during ICU stay.

  2. Length of ICU stay

    Time frame: 4 to 7 days

    Length of ICU stay

  3. ICU mortality

    Time frame: 4 to 7 days

    ICU mortality during ICU Stay

Study contacts

Contact information is provided by the study sponsor or research team.

Hager R. Elsofey, MBBCh

CONTACT

[email protected]

+201153153624

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

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.

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