An interventional study of Mini-bolus in Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 28 Days to 15 Years. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 11 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* First injection of 2ml/kg (saline solution) * Second injection of 18ml/kg (saline solution)
Procedure: Mini-bolus
* First injection of 2ml/kg (saline solution) * Second injection of 18ml/kg (saline solution)
Cardiac output variability (ΔCO)
Cardiac output
Time frame: 5 minutes
Cardiac output variability (ΔCO)
Cardiac output : ΔCO (mL/min) = VES (ml)\* heart rate and VES (cm3)= ITVA0(cm) \* SA0 (cm2)
Time frame: 15 minutes
Heart rate variation (ΔHR)
Heart rate usual monitoring
Time frame: 15 minutes
Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
Arterial pressure invasive or not invasive monitoring according the care of patient
Time frame: 5 minutes
Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
Arterial pressure invasive or not invasive monitoring according the care of patient
Time frame: 15 minutes
Pulse pressure variation (ΔPP)
Pulse pressure invasive or not invasive monitoring according the care of patient
Time frame: 5 minutes
Pulse pressure variation (ΔPP)
Pulse pressure invasive or not invasive monitoring according the care of patient
Time frame: 15 minutes
Systolic ejection volume variation (ΔSEV)
Systolic ejection volume is measured by transthoracic echocardiography : VES (ml) =ITVa0\*Sa0
Time frame: 5 minutes
Systolic ejection volume variation (ΔSEV)
Systolic ejection volume is measured by transthoracic echocardiography : VES (ml) =ITVa0\*Sa0
Time frame: 15 minutes
Velocity time-index variation (ΔVTI)
ITVA0 is measured by transthoracic echocardiography with Doppler
Time frame: 5 minutes
Velocity time-index variation (ΔVTI)
ITVA0 is measured by transthoracic echocardiography with Doppler
Time frame: 15 minutes
Microvascular Flow Index variation (ΔMFI)
Microvascular Flow Index calculated by the Microscan software (Microvision)
Time frame: 5 minutes
Microvascular Flow Index variation (ΔMFI)
Microvascular Flow Index calculated by the Microscan software (Microvision)
Time frame: 15 min
Proportion Perfused Vessels variation (ΔPPV)
Proportion Perfused Vessels calculated by the Microscan software (Microvision)
Time frame: 5 minutes
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