Venous CongestionSERLUNCT07131228
Changes in Portal Vein Pulsatility Variability During a Tidal Volume Challenge Can Predict Fluid Tolerance
An observational study of Venous Congestion, run by Hospital Universitario de Gran Canaria Doctor Negrín.
Trial summary
In critically ill patients, appropriate fluid administration is one of the cornerstones of hemodynamic management, as both hypovolemia and fluid overload can negatively impact clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Congestion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Nov 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: This is a prospective study involving patients admitted to the intensive care unit (ICU) of a tertiary care hospital, who are under mechanical ventilation and present clinical indications for a fluid responsiveness test, such as oliguria or arterial hypotension
Who may be able to join
- Participants must meet all of the following:
- Age ≥ 18 years at the time of enrollment.
- Receiving controlled mechanical ventilation with a baseline tidal volume of 6 mL/kg of predicted body weight.
- Clinical indication for assessment of fluid responsiveness.
- Adequate acoustic window for ultrasound visualization of the portal vein.
Who cannot join
- Participants will be excluded if they have any of the following:
- Liver cirrhosis.
- Right heart failure, defined as any of the following on prior echocardiography:
- Tricuspid annular plane systolic excursion (TAPSE) < 16 mm
- S' wave < 10 cm/s
- Right ventricular fractional area change < 35%
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- Left heart failure (left ventricular ejection fraction < 50%).
- Intra-abdominal hypertension.
- Atrial fibrillation or other significant cardiac arrhythmias.
- Tricuspid regurgitation.
- Poor echogenic window preventing adequate ultrasound assessment.
- Presence of spontaneous breathing activity.
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
In critically ill patients, appropriate fluid administration is one of the cornerstones of hemodynamic management, as both hypovolemia and fluid overload can negatively impact clinical outcomes.
For years, fluid responsiveness-defined as an increase in cardiac output following volume administration-has guided decision-making in the postoperative ICU. However, fluid responsiveness alone does not guarantee fluid tolerance, which refers to the venous system's ability to accommodate volume without developing venous congestion or adverse effects such as pulmonary edema, renal or hepatic dysfunction.
Read more
The tidal volume challenge (TVC)-which consists of a transient increase in tidal volume from 6 to 8 mL/kg-has been shown to predict fluid responsiveness by enhancing the hemodynamic interaction between the heart and lungs during the cardiac cycle, as measured through dynamic arterial indices such as pulse pressure variation (PPV) or stroke volume variation (SVV). However, these indices do not provide information about fluid tolerance or the state of venous congestion.
Doppler ultrasound of the portal vein, specifically the portal pulsatility index (which under normal conditions presents as a continuous waveform due to the damping effects of the hepatic parenchyma and venous compliance), has been proposed as a non-invasive marker of systemic venous congestion. Studies have shown that an increase in the portal pulsatility index following volume loading may indicate the development of venous congestion and, therefore, poor fluid tolerance.
Since the tidal volume challenge transiently increases intrathoracic pressure and allows dynamic evaluation of cardiovascular responses, we propose that this interaction be assessed not only through arterial dynamic indices (which assess responsiveness) but also through changes in venous flow patterns-specifically, variations in portal pulsatility-so that both fluid responsiveness and tolerance can be predicted with the same test.
- Conditions
- Venous Congestion
- Keywords
- Fluid Responsiveness Fluid Tolerance
- Medical subject headings
- Hyperemia
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute change in the portal pulsatility index measured in critically ill patients immediately before and after an incraese of voclumen tidal (6 to 8 ml/kg) . Measurements will be obtained using Doppler ultrasonography in vena porta.
Measured: Measured immediately before and after the tidal volume challenge (1 minute).
Secondary outcomes (1)
To correlate changes in portal pulsatility during the test with clinical signs of fluid intolerance (e.g., acute kidney injury, pulmonary congestion).
The correlation between the change in portal pulsatility index (PPI) during the tidal volume challenge and the occurrence of clinical signs of fluid intolerance in critically ill patients. Clinical signs include acute kidney injury (as defined by KDIGO criteria), pulmonary congestion r lung ultrasound), and other hemodynamic indicators of poor fluid tolerance (proBNP).
Measured: Assessed during the first 48 hours post-challenge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Nov 2026 (estimated)
- Primary completion28 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous CongestionStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucia Valencia, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131228
- Sponsor's protocol ID
- DrNegrinUH0000
- Acronym
- SERLU
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Portal Vein Pulsatility Variability During a Tidal Volume Challenge Can Predict Fluid Tolerance
- ClinicalTrials.gov ID
- NCT07131228
- Acronym / sponsor ID
- SERLU / DrNegrinUH0000
- Conditions
- Venous Congestion
- Keywords
- Fluid Responsiveness Fluid Tolerance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 28 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 20 Aug 2025 (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.
In critically ill patients, appropriate fluid administration is one of the cornerstones of hemodynamic management, as both hypovolemia and fluid overload can negatively impact clinical outcomes.
For years, fluid responsiveness-defined as an increase in cardiac output following volume administration-has guided decision-making in the postoperative ICU. However, fluid responsiveness alone does not guarantee fluid tolerance, which refers to the venous system's ability to accommodate volume without developing venous congestion or adverse effects such as pulmonary edema, renal or hepatic dysfunction.
The tidal volume challenge (TVC)-which consists of a transient increase in tidal volume from 6 to 8 mL/kg-has been shown to predict fluid responsiveness by enhancing the hemodynamic interaction between the heart and lungs during the cardiac cycle, as measured through dynamic arterial indices such as pulse pressure variation (PPV) or stroke volume variation (SVV). However, these indices do not provide information about fluid tolerance or the state of venous congestion.
Doppler ultrasound of the portal vein, specifically the portal pulsatility index (which under normal conditions presents as a continuous waveform due to the damping effects of the hepatic parenchyma and venous compliance), has been proposed as a non-invasive marker of systemic venous congestion. Studies have shown that an increase in the portal pulsatility index following volume loading may indicate the development of venous congestion and, therefore, poor fluid tolerance.
Since the tidal volume challenge transiently increases intrathoracic pressure and allows dynamic evaluation of cardiovascular responses, we propose that this interaction be assessed not only through arterial dynamic indices (which assess responsiveness) but also through changes in venous flow patterns-specifically, variations in portal pulsatility-so that both fluid responsiveness and tolerance can be predicted with the same test.
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
- This is a prospective study involving patients admitted to the intensive care unit (ICU) of a tertiary care hospital, who are under mechanical ventilation and present clinical indications for a fluid responsiveness test, such as oliguria or arterial hypotension
Key inclusion criteria (5 listed)
- Age ≥ 18 years at the time of enrollment.
- Receiving controlled mechanical ventilation with a baseline tidal volume of 6 mL/kg of predicted body weight.
- Clinical indication for assessment of fluid responsiveness.
- Adequate acoustic window for ultrasound visualization of the portal vein.
Key exclusion criteria (12 listed)
- Liver cirrhosis.
- Tricuspid annular plane systolic excursion (TAPSE) < 16 mm
- S' wave < 10 cm/s
- Right ventricular fractional area change < 35%
- Left heart failure (left ventricular ejection fraction < 50%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The absolute change in the portal pulsatility index measured in critically ill patients immediately before and after an incraese of voclumen tidal (6 to 8 ml/kg) . Measurements will be obtained using Doppler ultrasonography in vena porta.
Time frame: Measured immediately before and after the tidal volume challenge (1 minute).
1 secondary outcome
To correlate changes in portal pulsatility during the test with clinical signs of fluid intolerance (e.g., acute kidney injury, pulmonary congestion).
Time frame: Assessed during the first 48 hours post-challenge.
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 6 Jul 2026.
- Individual participant dataSharing planned: No
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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 Venous Congestion, run by Hospital Universitario de Gran Canaria Doctor Negrín.
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 5 inclusion and 12 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 6 Jul 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 LUCIA VALENCIA, PHD (34651010208, ORI98ES@YAHOO.ES), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absolute change in the portal pulsatility index measured in critically ill patients immediately before and after an incraese of voclumen tidal (6 to 8 ml/kg) . Measurements will be obtained using Doppler ultrasonography in vena porta. (time frame: Measured immediately before and after the tidal volume challenge (1 minute).). 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 6 Jul 2026.