Acute Respiratory Distress Syndrome (ARDS)NCT07545252
Effect of Positive End-Expiratory Pressure Titration on Venous Excess Ultrasound Score and Renal Outcomes in Patients With Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by Fayoum University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- VExUS score
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2026to 12 Oct 2026
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients with ARDS within 24 hours of onset and mechanically ventilated for more than 24 hours.
Who may be able to join
- Age ≥18 years.
- Diagnosis of ARDS according to the Berlin criteria.
- Invasive mechanical ventilation ≥24 hours.
- Requirement of PEEP ≥5 cmH₂O.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- VExUS score
- Keywords
- ARDS, mechanically ventilatuon, PEEP Titration, VExUS
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VExUS scoreOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
VExUS score
Change in VExUS score in relation to different PEEP levels in mechanically ventilated patients with ARDS.
Measured: 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.
Measured: 3 days
Secondary outcomes (3)
Requirement for renal replacement therapy (RRT) during ICU stay.
Requirement for renal replacement therapy (RRT) during ICU stay.
Measured: 3 days
Length of ICU stay
Length of ICU stay
Measured: 4 to 7 days
ICU mortality
ICU mortality during ICU Stay
Measured: 4 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start12 Apr 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Rabie Elsofey Mohammed, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545252
- Sponsor's protocol ID
- M869
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positive End-Expiratory Pressure Titration on Venous Excess Ultrasound Score and Renal Outcomes in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07545252
- Acronym / sponsor ID
- M869
- Keywords
- ARDS, mechanically ventilatuon, PEEP Titration, VExUS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 12 Apr 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with ARDS within 24 hours of onset and mechanically ventilated for more than 24 hours.
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Diagnosis of ARDS according to the Berlin criteria.
- Invasive mechanical ventilation ≥24 hours.
- Requirement of PEEP ≥5 cmH₂O.
Key exclusion criteria (6 listed)
- Known end-stage renal disease on chronic dialysis.
- History of renal transplantation.
- Pregnancy.
- Known severe tricuspid regurgitation.
- Chronic liver disease with portal hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VExUS scoreThe 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. | Other | – |
Primary outcome
VExUS score
Time frame: 3 days
Change in VExUS score in relation to different PEEP levels in mechanically ventilated patients with ARDS.
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 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by Fayoum University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hager R. Elsofey, MBBCh (+201153153624, hra13@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VExUS score (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.