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A drop of blood may reveal hidden fluid leaks in sepsis

NCT ID NCT07733206

Knowledge-focused Sponsor: University Hospital Center of Martinique Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This pilot study tests whether a new index, based on changes in hemoglobin levels after a standard fluid infusion, can measure capillary leak in people with septic shock. Researchers will compare this index to known markers of blood vessel damage in 100 ICU patients. If it works, the index could offer a simple, bedside tool to guide fluid therapy.

What this could mean

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

Active substance
standardised fluid bolus of Ringer's lactate
What this could lead to
If validated, this simple index could help doctors tailor fluid therapy for septic shock patients, reducing complications from too much or too little fluid.
What could go wrong
This is a small pilot study testing a new formula, not a proven tool. The index may not correlate well with existing biomarkers or improve outcomes.

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 100 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

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: * Test group (septic shock patients): * Adults admitted to the general ICU within 24 hours with a diagnosis of septic shock * Eligible for blood sampling during daytime hours Control group (non septic shock patients): * Adults admitted to the postoperative ICU within 24 hours after surgery * Need for fluid resuscitation * Eligible for blood sampling during daytime hours * Patients with an arterial catheter in place as part of their care Exclusion Criteria: * \- Clarkson's disease (idiopathic capillary leak syndrome) * Pre-existing extracellular fluid overload (e.g., cirrhosis, decompensated heart failure, nephrotic syndrome, chronic kidney disease on or awaiting dialysis) * Active bleeding or hemolysis * Receiving ECMO * Ongoing renal replacement therapy during the intervention * Blood transfusion within one hour before the intervention * Change in vasopressor or inotrope dose within 30 minutes before the intervention

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis toxic shock syndrome

As listed by the trial registrant

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

Sepsis

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

  • CHUM

    Fort-de-France, Martinique, 97261, Martinique

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