Tiny fluid injection may help doctors avoid dangerous fluid overload in septic kids
NCT ID NCT04027699
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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11 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Feb 2023
- Lead sponsor
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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
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28 days to 15 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpital Necker Enfants-Malades
Paris, 75015, France