Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock

Not Applicable

Completed

• Conditions: Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit
• Interventions: Procedure: Mini-bolus

• Registration Number: NCT04027699
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-22
• Study Start: 2021-02-23
• Primary Completion: 2022-10-19
• Study Completion: 2023-02-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mini-bolus	Mini-bolus	* First injection of 2ml/kg (saline solution) * Second injection of 18ml/kg (saline solution)

Primary Outcome Measures

Name	Time	Method
Cardiac output variability (ΔCO)	15 minutes	Cardiac output : ΔCO (mL/min) = VES (ml)\* heart rate and VES (cm3)= ITVA0(cm) \* SA0 (cm2)

Secondary Outcome Measures

Name	Time	Method
Heart rate variation (ΔHR)	15 minutes	Heart rate usual monitoring
Microvascular Flow Index variation (ΔMFI)	15 min	Microvascular Flow Index calculated by the Microscan software (Microvision)
Pulse pressure variation (ΔPP)	15 minutes	Pulse pressure invasive or not invasive monitoring according the care of patient
Velocity time-index variation (ΔVTI)	15 minutes	ITVA0 is measured by transthoracic echocardiography with Doppler
Systolic ejection volume variation (ΔSEV)	15 minutes	Systolic ejection volume is measured by transthoracic echocardiography : VES (ml) =ITVa0\*Sa0
Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)	15 minutes	Arterial pressure invasive or not invasive monitoring according the care of patient
Proportion Perfused Vessels variation (ΔPPV)	5 minutes	Proportion Perfused Vessels calculated by the Microscan software (Microvision)

Trial Locations

Locations (1)

Hôpital Necker Enfants-Malades; 🇫🇷 Paris, France