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Ultrasound of the portal vein may reveal fluid tolerance in critical care

NCT ID NCT07131228

Knowledge-focused Sponsor: Hospital Universitario de Gran Canaria Doctor Negrín Source: ClinicalTrials.gov ↗

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By invitation only
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Paused for now. It may or may not start again.
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Completed
The trial has finished. Results may not be published yet.
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Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study investigates whether a temporary increase in tidal volume (from 6 to 8 mL/kg) can help predict fluid tolerance in critically ill patients on mechanical ventilation. The researchers will use Doppler ultrasound to measure changes in the portal vein's pulsatility index, a marker of venous congestion. The goal is to see if this test can identify patients who might be harmed by additional fluids, potentially improving fluid management in the ICU.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could give doctors a simple, non-invasive way to predict whether giving fluids will harm or help critically ill patients.
What could go wrong
This is a small, early-stage study (60 participants) focused on a specific ICU population. The findings may not apply to other patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Exclusion Criteria: 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% 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.

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Conditions

The condition(s) this trial relates to.

Hyperemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Venous congestion

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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