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

April 16, 2026 updated by: Hager Rabie Elsofey Mohammed, Fayoum University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VExUS score
Time Frame: 3 days
Change in VExUS score in relation to different PEEP levels in mechanically ventilated patients with ARDS.
3 days
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.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Requirement for renal replacement therapy (RRT) during ICU stay.
Time Frame: 3 days
Requirement for renal replacement therapy (RRT) during ICU stay.
3 days
Length of ICU stay
Time Frame: 4 to 7 days
Length of ICU stay
4 to 7 days
ICU mortality
Time Frame: 4 to 7 days
ICU mortality during ICU Stay
4 to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 12, 2026

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

October 12, 2026

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M869

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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