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New study aims to take the guesswork out of IV fluids for critically ill patients

NCT ID NCT07304661

Knowledge-focused Sponsor: Izmir Katip Celebi University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 48 critically ill adults on breathing machines to see which method better predicts if they need more fluids. Doctors will compare a standard blood pressure measure with an ultrasound-based heart measurement during a leg-raising test. The goal is to help ICU teams give the right amount of fluids, avoiding harm from too little or too much.

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 48 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 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 critically ill patients admitted to the Intensive Care Unit (ICU) who are receiving mechanical ventilation support. Eligible participants are those identified by the intensive care team as having a suspected intravascular fluid deficit, for whom a fluid responsiveness assessment is clinically indicated. The cohort specifically targets patients undergoing the Passive Leg Raising (PLR) maneuver as part of routine standard practice, where invasive arterial monitoring is available to record Pulse Pressure Variation (PPV).

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: 1. Adult patients aged ≥18 years 2. Patients admitted to the intensive care unit receiving mechanical ventilation 3. Presence of suspected intravascular fluid deficit (hypotension, negative fluid balance, or clinical signs of peripheral hypoperfusion) 4. Patients in sinus rhythm 5. Presence of invasive arterial blood pressure monitoring 6. Adequate echocardiographic window allowing transthoracic echocardiographic measurement of LVOT VTI 7. Patients ventilated with tidal volume ≥8 mL/kg (ideal body weight) 8. Hemodynamically stable enough to allow measurement Exclusion Criteria: 1. Patients under 18 years of age 2. Presence of atrial fibrillation or significant arrhythmias such as frequent ventricular or atrial ectopy 3. Severe right ventricular dysfunction or significant tricuspid regurgitation 4. Advanced aortic valve disease (severe stenosis or severe regurgitation) 5. Patients with significant spontaneous breathing effort 6. Patients receiving lung-protective low tidal volume ventilation strategy (\<8 mL/kg) due to ARDS 7. Inadequate echocardiographic window for LVOT VTI assessment 8. Severe hemodynamic instability during measurement (sudden vasopressor escalation or need for resuscitation) 9. Patients who refuse to participate or from whom written informed consent cannot be obtained from themselves or a first-degree relative

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Conditions

The condition(s) this trial relates to.

Critical Illness Hypovolemia

As listed by the trial registrant

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

Critical illness Hemodynamic instability Hypovolemia Pulse pressure variation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Izmir Katip Celebi University Atatürk Training and Research Hospital İzmir, , Turkey

    Izmir, Turkey (Türkiye)

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Other studies related to the condition(s) this trial covers.