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New fluid strategy aims to reduce organ failure in septic shock

NCT ID NCT03461900

Disease control Sponsor: University Hospital, Brest 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study tested a personalized approach to fluid management in 535 adults with septic shock. Doctors used a 'mini-fluid challenge'—a small amount of albumin given quickly—to check if more fluids would help, aiming to avoid fluid overload. The goal was to see if this tailored method could reduce organ failure compared to standard care.

What this could mean

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

Active substance
mini-fluid challenge (100 ml of 4% human serum albumin)
What this could lead to
If successful, this approach could help doctors better manage fluid levels in septic shock patients, potentially reducing organ damage and improving recovery.
What could go wrong
This is a completed trial, but the intervention is a management strategy, not a new drug. Benefits may be modest and depend on how well it's implemented in different ICUs.

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

535 people

The number who actually took part.

Started

Jun 2019

Finished

Jan 2024

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: * Adult patient (Age \> 18 years) * Admitted in ICU for less than 3 days. * Abdominal (excepted urinary tract infection) or pulmonary related septic shock, defined by SEPSIS III criteria diagnosed within less than 12 hours. * Written consent or oral by the patient (and/or consent signed by the next of skin) * Patient has social security affiliation or who beneficiary of such social security Exclusion Criteria: * Patient with life expectancy inferior to 24 hours at the time of inclusion. * Cardiac arrest * Allergy to albumin * Pregnancy * Traumatic brain injury * Limitation of invasive therapeutics, palliative care * Patient under guardianship or curatorship

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Conditions

The condition(s) this trial relates to.

Edema toxic shock syndrome

As listed by the trial registrant

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

Septic shock

Contacts and locations

Locations

  • Angers university hospital

    Angers, France

  • Besançon university hospital

    Besançon, France

  • Brest university hospital

    Brest, 29200, France

  • Brest university hospital

    Brest, France

  • Chartres Hospital

    Chartres, 28000, France

  • Clermont Ferrand university hospital

    Clermont-Ferrand, France

  • George Pompidou university hospital (APHP)

    Paris, France

  • Hôpital privé de l'ouest parisen

    Trappes, 78190, France

  • Kremlin Bicêtre university hospital (APHP)

    Paris, France

  • Le Mans hospital

    Le Mans, France

  • Marseille university horpital

    Marseille, France

  • Morlaix hospital

    Morlaix, France

  • Nantes university hospital

    Nantes, France

  • Nîmes university hospital

    Nîmes, 30029, France

  • Poitiers university hospital

    Poitiers, France

  • Rouen university hospital

    Rouen, France

  • Toulon hospital

    Toulon, France

  • Tours university hospital

    Tours, France

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