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Can simple tests guide fluid therapy in unconscious ICU patients?

NCT ID NCT06180902

Knowledge-focused Sponsor: Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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.
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at different methods to predict whether giving IV fluids will help raise blood pressure in patients with impaired consciousness. Researchers will compare tests like ultrasound of the vena cava, leg raising, and fluid challenges in 222 ICU patients. The goal is to find which methods are most accurate in this specific group, where data is currently lacking.

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 help doctors better decide when to give IV fluids to unconscious patients with low blood pressure, potentially improving outcomes.
What could go wrong
This is an observational study, not testing a new treatment. Results may not change practice directly, and individual patient factors can affect accuracy.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 222 people

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

Started

Jan 2024

Expected to finish

May 2026

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.

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: * Age ≥ 18 years. * Hospitalization in an intensive care unit * Level of consciousness on the FOUR scale ≤ 12 points * Planned infusion therapy * Presence of a central venous catheter or direct indication for catheterization * The decision of the medical council to include the patient in the study Exclusion Criteria: * Pulmonary edema * Absence of one or both lower extremities * Chronic kidney disease according to KDIGO classification ≥ stage 3b * Acute kidney injury grade 3 * Documented or suspected increased intracranial pressure (cerebral edema, brain compression, hydrocephalus, etc.). * Presence of mitral valve regurgitation \> grade 1 * Presence of aortic valve regurgitation \> grade 1 * Patients previously enrolled in the "COMPASS" study in the period of 12 preceding hours

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction hypotensive disorder

As listed by the trial registrant

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

Cognitive impairment Hypotension

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

  • Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology

    RECRUITING

    Moscow, Russia

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