Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit Clinical Trial
— PRECISEOfficial title:
Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock
| Verified date | January 2024 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | February 20, 2023 |
| Est. primary completion date | October 19, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 28 Days to 15 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Necker Enfants-Malades | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cardiac output variability (?CO) | Cardiac output | 5 minutes | |
| Primary | Cardiac output variability (?CO) | Cardiac output : ?CO (mL/min) = VES (ml)* heart rate and VES (cm3)= ITVA0(cm) * SA0 (cm2) | 15 minutes | |
| Secondary | Heart rate variation (?HR) | Heart rate usual monitoring | 15 minutes | |
| Secondary | Systolic, diastolic and mean arterial pressure variation (?SAP, ?DAP, ?MAP) | Arterial pressure invasive or not invasive monitoring according the care of patient | 5 minutes | |
| Secondary | Systolic, diastolic and mean arterial pressure variation (?SAP, ?DAP, ?MAP) | Arterial pressure invasive or not invasive monitoring according the care of patient | 15 minutes | |
| Secondary | Pulse pressure variation (?PP) | Pulse pressure invasive or not invasive monitoring according the care of patient | 5 minutes | |
| Secondary | Pulse pressure variation (?PP) | Pulse pressure invasive or not invasive monitoring according the care of patient | 15 minutes | |
| Secondary | Systolic ejection volume variation (?SEV) | Systolic ejection volume is measured by transthoracic echocardiography :
VES (ml) =ITVa0*Sa0 |
5 minutes | |
| Secondary | Systolic ejection volume variation (?SEV) | Systolic ejection volume is measured by transthoracic echocardiography :
VES (ml) =ITVa0*Sa0 |
15 minutes | |
| Secondary | Velocity time-index variation (?VTI) | ITVA0 is measured by transthoracic echocardiography with Doppler | 5 minutes | |
| Secondary | Velocity time-index variation (?VTI) | ITVA0 is measured by transthoracic echocardiography with Doppler | 15 minutes | |
| Secondary | Microvascular Flow Index variation (?MFI) | Microvascular Flow Index calculated by the Microscan software (Microvision) | 5 minutes | |
| Secondary | Microvascular Flow Index variation (?MFI) | Microvascular Flow Index calculated by the Microscan software (Microvision) | 15 min | |
| Secondary | Proportion Perfused Vessels variation (?PPV) | Proportion Perfused Vessels calculated by the Microscan software (Microvision) | 5 minutes |