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Tiny fluid injection may help doctors avoid dangerous fluid overload in septic kids

NCT ID NCT04027699

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looked at whether giving a small, fast fluid injection (mini-bolus) can help predict if a child with septic shock will benefit from more fluids. It included 11 children on breathing machines in intensive care. The goal was to find a simple way to guide fluid treatment and avoid giving too much fluid, which can be harmful.

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

11 people

The number who actually took part.

Started

Feb 2021

Finished

Feb 2023

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

28 days to 15 years

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: 1. Baby (\>28 days) or children \< 15 years 2. Hospitalisation in paediatric intensive 3. Clinico-biological table compatible with severe sepsis or septic shock (likely or documented) 4. Requiring the use of invasive mechanical ventilation 5. Affiliate or beneficiary of a social security 6. Legal guardians Consent Form or Emergency Procedure Exclusion Criteria: 1. Any serious hemodynamic clinical situation that would be delayed by inclusion in the protocol 2. Patient with shunt heart disease 3. Patient in spontaneous or non-invasive ventilation or CPAP 4. Patient with a contraindication to volemic/fluid expansion (major cardiac dysfunction, acute renal failure) 5. Patient with cardiac arrest upper 5 min 6. ECMO 7. Postcardiotomia

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Conditions

The condition(s) this trial relates to.

Sepsis

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hôpital Necker Enfants-Malades

    Paris, 75015, France