Critically Ill Intensive Care Unit PatientsNCT07732114
Diagnostic Accuracy of Hepatic Vein SFF Compared With TAPSE for Assessment of RV Systolic Function in Mechanically Ventilated Patients
An observational study of Critically Ill Intensive Care Unit Patients, run by Menoufia University at 1 site in Egypt.
Trial summary
This prospective observational diagnostic accuracy study investigates the efficacy of the hepatic vein systolic filling fraction (SFF) as a real-time, non-invasive indicator of right ventricular (RV) systolic function in critically ill patients admitted to the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Intensive Care Unit Patients
- What is being tested?
- Diagnostic accuracy of hepatic vein systolic filling fraction compared with TAPSE for assessment of right ventricular systolic function in mechanically ventilated critically ill patients
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2026to 15 Jul 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Age ≥ 18 years. 2. Mechanically ventilated patients 3. Patients in whom transthoracic echocardiography (TTE) can be performed Adequate acoustic window to measure TAPSE. 4. Patients in whom hepatic vein Doppler assessment is feasible Adequate subcostal view for Doppler sampling.
Who may be able to join
- Age ≥ 18 years.
- Mechanically ventilated patients
- Patients in whom transthoracic echocardiography (TTE) can be performed Adequate acoustic window to measure TAPSE.
- Patients in whom hepatic vein Doppler assessment is feasible Adequate subcostal view for Doppler sampling.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia University
Alexandria, Shebin El-Kom, 32511
Nevine Mostafa Soliman, +201128861471, mostafanevine@gmail.com
About this study
Official title: Diagnostic Accuracy of Hepatic Vein Systolic Filling Fraction Compared With TAPSE for Assessment of Right Ventricular Systolic Function in Mechanically Ventilated Critically Ill Patients
This prospective observational diagnostic accuracy study investigates the efficacy of the hepatic vein systolic filling fraction (SFF) as a real-time, non-invasive indicator of right ventricular (RV) systolic function in critically ill patients admitted to the intensive care unit.
- Being tested
- Diagnostic accuracy of hepatic vein systolic filling fraction compared with TAPSE for assessment of right ventricular systolic function in mechanically ventilated critically ill patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic accuracy of hepatic vein systolic filling fraction compared with TAPSE for assessment of right ventricular systolic function in mechanically ventilated critically ill patientsDiagnostic test
- Point-of-Care Echocardiography Protocol Echocardiograms were recorded within the first 24 hours of ICU admission using an echocardiograph by two intensivists who were experienced in echocardiography (more than 7 years of experience) and will be blinded to the study. Electrocardiograms were recorded continuously during the echocardiographic examination. Images will be saved for offline analysis. The ultrasound machine will be equipped with a phased-array transducer.
Right Ventricular Assessment: From the apical 4-chamber view, the M-mode cursor will be aligned with the lateral aspect of the tricuspid valve annulus to measure the Tricuspid Annular Plane Systolic Excursion (TAPSE). To ensure accuracy and account for beat-to-beat variability, the final TAPSE value recorded for each patient will be the average of measurements taken over three consecutive cardiac cycles. Right ventricular systolic dysfunction (RVSD) is strictly defined as an average TAPSE of < 16 mm (7).
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic vein systolic filling fraction (SFF) and Tricuspid Annular Plane Systolic Excursion (TAPSE)
Hepatic vein systolic filling fraction (SFF) will be measured using colour Doppler ultrasonography of the hepatic vein. Examinations will be performed within a 5-minute window of transthoracic echocardiography and obtained at end-expiration to minimise the effects of respiratory variation. All patients will be mechanically ventilated, and positive end-expiratory pressure (PEEP) and plateau pressure will be recorded at the time of assessment.
Unit:
Percentage (%) Right ventricular systolic function will be assessed by measuring tricuspid annular plane systolic excursion (TAPSE) using transthoracic echocardiography at the bedside. Echocardiographic examination will be performed within a 5-minute window of hepatic vein Doppler assessment and obtained at end-expiration to minimise respiratory variation. All patients will be mechanically ventilated, and positive end-expiratory pressure (PEEP) and plateau pressure will be recorded at the time of assessment.
Unit:
Millimetres mm
Measured: within the first 24 hours
Secondary outcomes (1)
Baseline Demographic and Clinical Data, Synchronized Hemodynamic and Respiratory Data, Total length of ICU stay (days) and ICU mortality and the correlation and agreement between the hepatic vein and RV systolic function via TAPSE.
To determine the correlation and agreement between the hepatic vein SFF and right ventricular (RV) systolic function Unit of Measure Correlation coefficient (Pearson's r or Spearman's ρ), quantitatively assessed via Tricuspid Annular Plane Systolic Excursion (TAPSE) at the bedside. Tricuspid Annular Plane Systolic Excursion (TAPSE) should be < 16 mm.
SFF cut-off of ≤ 54.5% for predicting RV dysfunction measured by Agreement statistic (e.g., Cohen's kappa or intraclass correlation coefficient) and diagnostic accuracy measures (sensitivity, specificity, area under the receiver operating characteristic curve) .
Base line demographic data (wt in kg , height in meter, sex), clinical, laboratory characteristics off all patients and the Sequential Organ Failure Assessment (SOFA) Score by points and the Acute Physiology and Chronic Health Evaluation (APACHE) score by score.
Total duration of invasive mechanical ventilation in days. Intensive Care Unit (ICU) length of stay in days.
Measured: till 28 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start10 Sep 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill Intensive Care Unit PatientsStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevine Mostafa Soliman, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732114
- Sponsor's protocol ID
- 6/2026ANET30
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Hepatic Vein Systolic Filling Fraction Compared With TAPSE for Assessment of Right Ventricular Systolic Function in Mechanically Ventilated Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07732114
- Acronym / sponsor ID
- 6/2026ANET30
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 28 Jul 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 prospective observational diagnostic accuracy study investigates the efficacy of the hepatic vein systolic filling fraction (SFF) as a real-time, non-invasive indicator of right ventricular (RV) systolic function in critically ill patients admitted to the intensive care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Age ≥ 18 years. 2. Mechanically ventilated patients 3. Patients in whom transthoracic echocardiography (TTE) can be performed Adequate acoustic window to measure TAPSE. 4. Patients in whom hepatic vein Doppler assessment is feasible Adequate subcostal view for Doppler sampling.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Mechanically ventilated patients
- Patients in whom transthoracic echocardiography (TTE) can be performed Adequate acoustic window to measure TAPSE.
- Patients in whom hepatic vein Doppler assessment is feasible Adequate subcostal view for Doppler sampling.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Diagnostic accuracy of hepatic vein systolic filling fraction compared with TAPSE for assessment of right ventricular systolic function in mechanically ventilated critically ill patients1. Point-of-Care Echocardiography Protocol Echocardiograms were recorded within the first 24 hours of ICU admission using an echocardiograph by two intensivists who were experienced in echocardiography (more than 7 years of experience) and will be blinded to the study. Electrocardiograms were recorded continuously during the echocardiographic examination. Images will be saved for offline analysis. The ultrasound machine will be equipped with a phased-array transducer. Right Ventricular Assessment: From the apical 4-chamber view, the M-mode cursor will be aligned with the lateral aspect of the tricuspid valve annulus to measure the Tricuspid Annular Plane Systolic Excursion (TAPSE). To ensure accuracy and account for beat-to-beat variability, the final TAPSE value recorded for each patient will be the average of measurements taken over three consecutive cardiac cycles. Right ventricular systolic dysfunction (RVSD) is strictly defined as an average TAPSE of < 16 mm (7). | Diagnostic test | – |
Primary outcome
Hepatic vein systolic filling fraction (SFF) and Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time frame: within the first 24 hours
Hepatic vein systolic filling fraction (SFF) will be measured using colour Doppler ultrasonography of the hepatic vein. Examinations will be performed within a 5-minute window of transthoracic echocardiography and obtained at end-expiration to minimise the effects of respiratory variation. All patients will be mechanically ventilated, and positive end-expiratory pressure (PEEP) and plateau pressure will be recorded at the time of assessment. Unit: Percentage (%) Right ventricular systolic function will be assessed by measuring tricuspid annular plane systolic excursion (TAPSE) using transthoracic echocardiography at the bedside. Echocardiographic examination will be performed within a 5-minute window of hepatic vein Doppler assessment and obtained at end-expiration to minimise respiratory variation. All patients will be mechanically ventilated, and positive end-expiratory pressure (PEEP) and plateau pressure will be recorded at the time of assessment. Unit: Millimetres mm
1 secondary outcome
Baseline Demographic and Clinical Data, Synchronized Hemodynamic and Respiratory Data, Total length of ICU stay (days) and ICU mortality and the correlation and agreement between the hepatic vein and RV systolic function via TAPSE.
Time frame: till 28 days after admission
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 10 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill Intensive Care Unit Patients, run by Menoufia University at 1 site in Egypt.
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 0 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Nevine Mostafa Soliman, Ass. Prof. (+201128861471, mostafanevine@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic vein systolic filling fraction (SFF) and Tricuspid Annular Plane Systolic Excursion (TAPSE) (time frame: within the first 24 hours). 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 10 Sep 2026.