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Simple leg ultrasound may guide Life-Saving fluid decisions in shock patients

NCT ID NCT07546656

Knowledge-focused Sponsor: Istanbul University - Cerrahpasa Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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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Expanded access (ended)
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

Details not published
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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 100 ICU patients with shock who are on a breathing machine. Doctors will use an ultrasound to measure the size of a vein and artery in the leg. They want to see if this ratio can tell whether giving fluids will help the heart pump more blood. The goal is to find a simple, non-invasive way to guide treatment.

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Study facts

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

Participants

About 100 people

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

Started

May 2026

Expected to finish

Mar 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

The study population consists of adult intensive care unit patients with acute circulatory failure or shock who are receiving invasive mechanical ventilation and for whom the responsible intensive care physician has determined a clinical indication for a fluid challenge. Only patients who already have PiCCO monitoring in place as part of routine clinical care and in whom femoral vein and femoral artery ultrasonographic measurements can be obtained will be enrolled.

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: * Adult patients aged 18 years or older * Admission to the intensive care unit where the study is being conducted * Receiving invasive mechanical ventilation * Clinical indication for a fluid challenge due to acute circulatory failure or shock, as determined by the responsible intensive care physician * PiCCO monitoring already in place as part of routine clinical care * Clinical conditions allowing collection of pre- and post-fluid challenge cardiac index and ultrasonographic measurements * Technical feasibility of femoral vein and femoral artery diameter measurements by ultrasonography Exclusion Criteria: * Age younger than 18 years * Failure to obtain written informed consent from the patient or legally authorized representative before enrollment * Absence of PiCCO monitoring as part of routine clinical care or no clinical plan for fluid challenge * Inability to complete pre- and post-fluid challenge measurements (e.g., early death, urgent surgery, transfer) * Local conditions preventing reliable femoral ultrasonographic assessment, including open wound, infection, dressing, major anatomic obstacle, poor image quality, known femoral vein thrombosis, or severe vascular pathology on the relevant side * Conditions likely to significantly impair the reliability of thermodilution measurements (e.g., severe tricuspid regurgitation or significant intracardiac shunt) * Major treatment changes during the fluid challenge that preclude comparable measurements (e.g., major vasopressor dose change, major ventilator setting change, new arrhythmia) * Missing or inadequate data judged by the investigators to compromise data integrity, including absence of measurements required for the primary outcome

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Conditions

The condition(s) this trial relates to.

cardiogenic shock Shock

As listed by the trial registrant

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

Acute circulatory failure Fluid responsiveness Shock

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Istanbul University Cerrahpasa Medical Faculty

    RECRUITING

    Istanbul, Istanbul, Turkey (Türkiye)

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