Severe Sepsis or Septic Shock in Pediatric Intensive Care UnitPRECISENCT04027699
Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock
A study testing Mini-bolus in people with Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Severe sepsis and septic shock remain of particular gravity in children with a current mortality of about 20 % , despite the international prevention campaigns " survival sepsis campaign ". Septic shock associates a macrocirculatory and a microcirculatory dysfunction. Read more about this study
- Who is it for?
- Ages 28 days to 15 years
- Conditions the study is for
- Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit
- What is being tested?
- Mini-bolus
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2021to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Baby (>28 days) or children < 15 years
- Hospitalisation in paediatric intensive
- Clinico-biological table compatible with severe sepsis or septic shock (likely or documented)
- Requiring the use of invasive mechanical ventilation
- Affiliate or beneficiary of a social security
- Legal guardians Consent Form or Emergency Procedure
Who cannot join
- Any serious hemodynamic clinical situation that would be delayed by inclusion in the protocol
- Patient with shunt heart disease
- Patient in spontaneous or non-invasive ventilation or CPAP
- Patient with a contraindication to volemic/fluid expansion (major cardiac dysfunction, acute renal failure)
- Patient with cardiac arrest upper 5 min
- ECMO
- Postcardiotomia
Trial locations and contacts
1 site in 1 country.
About this study
Severe sepsis and septic shock remain of particular gravity in children with a current mortality of about 20 % , despite the international prevention campaigns " survival sepsis campaign ". Septic shock associates a macrocirculatory and a microcirculatory dysfunction. The volume expansion remains the treatment of severe sepsis at the initial phase supplemented by the use of vasopressors and / or inotropes. Nevertheless , it is essential to predict the fluid responsiveness after volemic expansion because fluid overload is associated with an increased morbidity in children. In studies , the volume expansion is considered effective if it allows an increase in cardiac output of more than 15 % compared to the basal level. However, their conditions of use remain very restrictive and not applicable to most of our patients ( tidal volume ≥ 7ml / kg , PEEP sufficient , absence of cardiac arrhythmia and effective sedation ) . To date , no index can be used for all patients with invasive mechanical ventilation.
It therefore seems appropriate to develop new tests to predict the response to volume expansion in children with septic shock hospitalized in pediatric intensive care.
Read more
A recent study has validated a test to predict the response to volume expansion in adults: injection of a mini-bolus of 50 ml of saline over 10s.
The aim of the study is to evaluate the effect of mini bolus fluid to predict response to fluid expansion in pediatric septic shock.
Read the detailed description
Severe sepsis and septic shock remain of particular gravity in children with a current mortality of about 20 % , despite the international prevention campaigns " survival sepsis campaign " . Septic shock associates a macrocirculatory and a microcirculatory dysfunction. The volume expansion remains the treatment of severe sepsis at the initial phase supplemented by the use of vasopressors and / or inotropes . Nevertheless , it is essential to predict the fluid responsiveness after volemic expansion because fluid overload is associated with an increased morbidity in children . In studies , the volume expansion is considered effective if it allows an increase in cardiac output of more than 15 % compared to the basal level . However , their conditions of use remain very restrictive and not applicable to most of our patients ( tidal volume > 7ml / kg , PEEP sufficient, absence of cardiac arrhythmia and effective sedation ) . To date , no index can be used for all patients with invasive mechanical ventilation .
It therefore seems appropriate to develop new tests to predict the response to volume expansion in children with septic shock hospitalized in pediatric intensive care.
A recent study has validated a test to predict the response to volume expansion in adults : injection of a mini-bolus of 50 ml of saline over 10s.
The aim of the study is to evaluate the effect of mini bolus fluid to predict response to fluid expansion in pediatric septic shock.
- Being tested
- Mini-bolus
- Keywords
- Mini-bolus challenge, fluid responsiveness, volemic expansion, pediatric septic shock, severe sepsis, microcirculation
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-bolusProcedure or surgery
- First injection of 2ml/kg (saline solution)
- Second injection of 18ml/kg (saline solution)
| Study group | Role | What they receive |
|---|---|---|
| Mini-bolus | Experimental | * First injection of 2ml/kg (saline solution)
* Second injection of 18ml/kg (saline solution) Receives: Procedure: Mini-bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output variability (ΔCO)
Cardiac output
Measured: 5 minutes
Cardiac output variability (ΔCO)
Cardiac output : ΔCO (mL/min) = VES (ml)* heart rate and VES (cm3)= ITVA0(cm) * SA0 (cm2)
Measured: 15 minutes
Secondary outcomes (12)
Heart rate variation (ΔHR)
Heart rate usual monitoring
Measured: 15 minutes
Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
Arterial pressure invasive or not invasive monitoring according the care of patient
Measured: 5 minutes
Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
Arterial pressure invasive or not invasive monitoring according the care of patient
Measured: 15 minutes
Pulse pressure variation (ΔPP)
Pulse pressure invasive or not invasive monitoring according the care of patient
Measured: 5 minutes
Pulse pressure variation (ΔPP)
Pulse pressure invasive or not invasive monitoring according the care of patient
Measured: 15 minutes
Systolic ejection volume variation (ΔSEV)
Systolic ejection volume is measured by transthoracic echocardiography :
VES (ml) =ITVa0*Sa0
Measured: 5 minutes
Systolic ejection volume variation (ΔSEV)
Systolic ejection volume is measured by transthoracic echocardiography :
VES (ml) =ITVa0*Sa0
Measured: 15 minutes
Velocity time-index variation (ΔVTI)
ITVA0 is measured by transthoracic echocardiography with Doppler
Measured: 5 minutes
Velocity time-index variation (ΔVTI)
ITVA0 is measured by transthoracic echocardiography with Doppler
Measured: 15 minutes
Microvascular Flow Index variation (ΔMFI)
Microvascular Flow Index calculated by the Microscan software (Microvision)
Measured: 5 minutes
Microvascular Flow Index variation (ΔMFI)
Microvascular Flow Index calculated by the Microscan software (Microvision)
Measured: 15 min
Proportion Perfused Vessels variation (ΔPPV)
Proportion Perfused Vessels calculated by the Microscan software (Microvision)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start23 Feb 2021
- Primary completion19 Oct 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Sepsis or Septic Shock in Pediatric Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Laurent Dupic, MD, Study chair, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027699
- Sponsor's protocol ID
- PRECISE
- Acronym
- PRECISE
- Status last verified
- Oct 2025
- First submitted
- 18 Jul 2019
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock
- ClinicalTrials.gov ID
- NCT04027699
- Acronym / sponsor ID
- PRECISE / PRECISE
- Keywords
- Mini-bolus challenge, fluid responsiveness, volemic expansion, pediatric septic shock, severe sepsis, microcirculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe sepsis and septic shock remain of particular gravity in children with a current mortality of about 20 % , despite the international prevention campaigns " survival sepsis campaign ". Septic shock associates a macrocirculatory and a microcirculatory dysfunction. The volume expansion remains the treatment of severe sepsis at the initial phase supplemented by the use of vasopressors and / or inotropes. Nevertheless , it is essential to predict the fluid responsiveness after volemic expansion because fluid overload is associated with an increased morbidity in children. In studies , the volume expansion is considered effective if it allows an increase in cardiac output of more than 15 % compared to the basal level. However, their conditions of use remain very restrictive and not applicable to most of our patients ( tidal volume ≥ 7ml / kg , PEEP sufficient , absence of cardiac arrhythmia and effective sedation ) . To date , no index can be used for all patients with invasive mechanical ventilation.
It therefore seems appropriate to develop new tests to predict the response to volume expansion in children with septic shock hospitalized in pediatric intensive care.
A recent study has validated a test to predict the response to volume expansion in adults: injection of a mini-bolus of 50 ml of saline over 10s.
The aim of the study is to evaluate the effect of mini bolus fluid to predict response to fluid expansion in pediatric septic shock.
Detailed description
Severe sepsis and septic shock remain of particular gravity in children with a current mortality of about 20 % , despite the international prevention campaigns " survival sepsis campaign " . Septic shock associates a macrocirculatory and a microcirculatory dysfunction. The volume expansion remains the treatment of severe sepsis at the initial phase supplemented by the use of vasopressors and / or inotropes . Nevertheless , it is essential to predict the fluid responsiveness after volemic expansion because fluid overload is associated with an increased morbidity in children . In studies , the volume expansion is considered effective if it allows an increase in cardiac output of more than 15 % compared to the basal level . However , their conditions of use remain very restrictive and not applicable to most of our patients ( tidal volume > 7ml / kg , PEEP sufficient, absence of cardiac arrhythmia and effective sedation ) . To date , no index can be used for all patients with invasive mechanical ventilation .
It therefore seems appropriate to develop new tests to predict the response to volume expansion in children with septic shock hospitalized in pediatric intensive care.
A recent study has validated a test to predict the response to volume expansion in adults : injection of a mini-bolus of 50 ml of saline over 10s.
The aim of the study is to evaluate the effect of mini bolus fluid to predict response to fluid expansion in pediatric septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mini-bolus | Experimental | Procedure: Mini-bolus* First injection of 2ml/kg (saline solution) * Second injection of 18ml/kg (saline solution) |
Who may qualify
- Ages
- 28 days to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Baby (>28 days) or children < 15 years
- Hospitalisation in paediatric intensive
- Clinico-biological table compatible with severe sepsis or septic shock (likely or documented)
- Requiring the use of invasive mechanical ventilation
- Affiliate or beneficiary of a social security
Key exclusion criteria (7 listed)
- Any serious hemodynamic clinical situation that would be delayed by inclusion in the protocol
- Patient with shunt heart disease
- Patient in spontaneous or non-invasive ventilation or CPAP
- Patient with a contraindication to volemic/fluid expansion (major cardiac dysfunction, acute renal failure)
- Patient with cardiac arrest upper 5 min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-bolus* First injection of 2ml/kg (saline solution) * Second injection of 18ml/kg (saline solution) | Procedure or surgery | Mini-bolus |
Primary outcome
Cardiac output variability (ΔCO)
Time frame: 5 minutes
Cardiac output
Cardiac output variability (ΔCO)
Time frame: 15 minutes
Cardiac output : ΔCO (mL/min) = VES (ml)* heart rate and VES (cm3)= ITVA0(cm) * SA0 (cm2)
12 secondary outcomes
Heart rate variation (ΔHR)
Time frame: 15 minutes
Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
Time frame: 5 minutes
Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
Time frame: 15 minutes
Pulse pressure variation (ΔPP)
Time frame: 5 minutes
Pulse pressure variation (ΔPP)
Time frame: 15 minutes
Systolic ejection volume variation (ΔSEV)
Time frame: 5 minutes
Systolic ejection volume variation (ΔSEV)
Time frame: 15 minutes
Velocity time-index variation (ΔVTI)
Time frame: 5 minutes
Velocity time-index variation (ΔVTI)
Time frame: 15 minutes
Microvascular Flow Index variation (ΔMFI)
Time frame: 5 minutes
Microvascular Flow Index variation (ΔMFI)
Time frame: 15 min
Proportion Perfused Vessels variation (ΔPPV)
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Dupic, MD study chair
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-bolus in people with Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output variability (ΔCO) (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.