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Breath test may prevent fluid overload in ICU patients

NCT ID NCT07304648

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

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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.
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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 Results may not be published yet.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)

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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
This status has not been confirmed recently, so it may be out of date.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 whether measuring changes in exhaled carbon dioxide (a breath test) during a leg-raising maneuver can help predict if a critically ill patient needs more fluids. Doctors often struggle to balance giving enough fluids without causing harm from too much. The study will observe 68 adults on breathing machines in the ICU, comparing the breath test to standard methods to see if it is a reliable, non-invasive tool.

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 68 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

Jul 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 patients (aged 18 years or older) admitted to the Intensive Care Unit (ICU) of a university hospital. Eligible participants are those who have been receiving mechanical ventilation support for at least 24 hours and have been identified by the primary intensive care team as requiring a fluid responsiveness assessment via a mini fluid challenge. The cohort includes patients with circulatory failure or suspected hypovolemia where fluid resuscitation is clinically indicated. Patients with contraindications to passive leg raising (e.g., intracranial hypertension, deep vein thrombosis), spontaneous breathing, or severe cardiac valve pathologies are excluded.

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: * Patients aged 18 years or older. * Patients who have been followed in the intensive care unit (ICU) with mechanical ventilation support for at least 24 hours. * Patients for whom a mini fluid challenge (MFC) is clinically planned by the intensive care team. * Patients for whom informed consent has been obtained from first-degree relatives or a legal representative. Exclusion Criteria: * Patients younger than 18 years of age. * Pregnant patients. * Patients without consent from first-degree relatives or a legal representative. * Patients with known deep vein thrombosis (DVT) in the leg veins (risk of embolism during leg raising). * Patients with pathologies that may cause increased intracranial pressure (e.g., intracranial mass, hemorrhage). * Patients with uncontrolled hypertension. * Patients with severe cardiac disease (e.g., right heart failure, pulmonary hypertension, advanced valvular pathology). * Patients with carbon dioxide (CO2) retention. * Patients who have undergone hip surgery or hip replacement surgery where Passive Leg Raising (PLR) cannot be performed. * Patients with spontaneous breathing. * Patients with a probability of high intra-abdominal pressure. * Patients who cannot lie in a supine position. * Patients with current peripheral oxygen saturation (SpO2) \< 88%. * Patients on mechanical ventilation requiring pressure support \> 16 mmHg or PEEP \> 10 mmHg.

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Conditions

The condition(s) this trial relates to.

cardiac arrest Critical Illness Hypovolemia Shock

As listed by the trial registrant

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

Circulatory failure Critical illness Hypovolemia

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

  • Izmir Katip Celebi University Atatürk Training and Research Hospital

    Izmir, Turkey (Türkiye)

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