Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock (PRECISE)

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 Overview

• Status: Completed
• Conditions: Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit
• Intervention / Treatment: Procedure: Mini-bolus

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hopital Necker Enfants-malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mini-bolus; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output variability (ΔCO)	Cardiac output	5 minutes
Cardiac output variability (ΔCO)	Cardiac output : ΔCO (mL/min) = VES (ml)* heart rate and VES (cm3)= ITVA0(cm) * SA0 (cm2)	15 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Study Chair: Laurent Dupic, MD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (Actual): July 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: microcirculation; fluid responsiveness; severe sepsis; Mini-bolus challenge; volemic expansion; pediatric septic shock
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: PRECISE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No