Clinical trial NCT04027699: Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock
Official title: Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit
Keywords: Mini-bolus challenge
fluid responsiveness
volemic expansion
pediatric septic shock
severe sepsis
microcirculation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 11
Sex: ALL
Minimum age (years): 28
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac output variability (ΔCO)
timeFrame: 5 minutes
measure: Cardiac output variability (ΔCO)
timeFrame: 15 minutes
Secondary outcomes:
measure: Heart rate variation (ΔHR)
timeFrame: 15 minutes
measure: Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
timeFrame: 5 minutes
measure: Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)
timeFrame: 15 minutes
measure: Pulse pressure variation (ΔPP)
timeFrame: 5 minutes
measure: Pulse pressure variation (ΔPP)
timeFrame: 15 minutes
measure: Systolic ejection volume variation (ΔSEV)
timeFrame: 5 minutes
measure: Systolic ejection volume variation (ΔSEV)
timeFrame: 15 minutes
measure: Velocity time-index variation (ΔVTI)
timeFrame: 5 minutes
measure: Velocity time-index variation (ΔVTI)
timeFrame: 15 minutes
measure: Microvascular Flow Index variation (ΔMFI)
timeFrame: 5 minutes
measure: Microvascular Flow Index variation (ΔMFI)
timeFrame: 15 min
measure: Proportion Perfused Vessels variation (ΔPPV)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants-Malades
Study officials:
affiliation: APHP
name: Laurent Dupic, MD
role: STUDY_CHAIR
References: