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

NCT07545252 | Not Yet Recruiting DMC

• 1 other identifier: M869
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

ARDS; mechanically ventilatuon; PEEP Titration; VExUS

Outcome Measures

Primary Outcomes (2)

• VExUS score

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

  3 days

• Development of acute kidney injury (AKI)

  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.

  3 days

Secondary Outcomes (3)

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

  3 days

• Length of ICU stay

  4 to 7 days

• ICU mortality

  4 to 7 days

Interventions

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.

Eligibility Criteria

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

Study Population

patients with ARDS within 24 hours of onset and mechanically ventilated for more than 24 hours.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Hager R. Elsofey, MBBCh

CONTACT

+201153153624; hra13@fayoum.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Critical Care Medicine

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 12, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): October 12, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04