Hôpital Necker Enfants-Malades
Paris, 75015, France
NCT Number: NCT04027699
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.
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Notify Me28 day–15 year
All sexes
Interventional
Not applicable
Paris, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 5 minutes
Cardiac output
Time frame: 15 minutes
Cardiac output : ΔCO (mL/min) = VES (ml)* heart rate and VES (cm3)= ITVA0(cm) * SA0 (cm2)
Time frame: 15 minutes
Heart rate usual monitoring
Time frame: 5 minutes
Arterial pressure invasive or not invasive monitoring according the care of patient
Time frame: 15 minutes
Arterial pressure invasive or not invasive monitoring according the care of patient
Time frame: 5 minutes
Pulse pressure invasive or not invasive monitoring according the care of patient
Time frame: 15 minutes
Pulse pressure invasive or not invasive monitoring according the care of patient
Time frame: 5 minutes
Systolic ejection volume is measured by transthoracic echocardiography :
VES (ml) =ITVa0*Sa0
Time frame: 15 minutes
Systolic ejection volume is measured by transthoracic echocardiography :
VES (ml) =ITVa0*Sa0
Time frame: 5 minutes
ITVA0 is measured by transthoracic echocardiography with Doppler
Time frame: 15 minutes
ITVA0 is measured by transthoracic echocardiography with Doppler
Time frame: 5 minutes
Microvascular Flow Index calculated by the Microscan software (Microvision)
Time frame: 15 min
Microvascular Flow Index calculated by the Microscan software (Microvision)
Time frame: 5 minutes
Proportion Perfused Vessels calculated by the Microscan software (Microvision)
Assistance Publique - Hôpitaux de Paris
Other
Acronym: PRECISE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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