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Balancing fluids in sepsis: a study to prevent harm

NCT ID NCT07685002

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study observes how the bodies of people with septic shock respond to fluid loading, a common treatment. Researchers track markers of blood flow and fluid buildup to see which patients improve and which get worse. The goal is to find better ways to give fluids without causing harm.

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 personalize fluid therapy for septic shock patients, potentially reducing organ damage and improving survival.
What could go wrong
This is an observational study, not a treatment trial. It may not identify clear predictors or lead to immediate changes in care.

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 170 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 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.

Who is studied

Patients with septic shock, defined according to proven or suspected infection with hypotension requiring vasopressor therapy, either community or hospital onset.

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 with septic shock, defined according to proven or suspected infection with hypotension requiring vasopressor therapy, either community or hospital onset. * Mechanical ventilation * Central venous catheter in the superior vena cava territory * Arterial catheter in place * Positive passive leg-raising (PLR) test-defined as an increase of \>10% in subaortic velocity-time integral-which predicts responsiveness to fluid loading. Exclusion Criteria: * Contraindication to performing a passive leg-raising manoeuvre (e.g., unstable spinal fracture, intracranial hypertension, critical limb ischemia). * Age \< 18 years. * Lack of social coverage or individuals deprived of liberty. * Pregnant women. * Extracorporeal membrane oxygenation (veno-venous or venoarterial) * Cirrhosis with portal hypertension or portal vein thrombosis * Inability to obtain non-opposition from the patient or their legal representative.

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Conditions

The condition(s) this trial relates to.

Sepsis Shock toxic shock syndrome

As listed by the trial registrant

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

Septic shock

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

  • Hôpital Ambroise Paré, APHP

    Boulogne-Billancourt, 92100, France

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