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Completed

NCT Number: NCT04027699

Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock

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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Key information

Age range

28 day–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker Enfants-Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Baby (>28 days) or children < 15 years
  • Hospitalisation in paediatric intensive
  • Clinico-biological table compatible with severe sepsis or septic shock (likely or documented)
  • Requiring the use of invasive mechanical ventilation
  • Affiliate or beneficiary of a social security
  • Legal guardians Consent Form or Emergency Procedure

Exclusion criteria

  • Any serious hemodynamic clinical situation that would be delayed by inclusion in the protocol
  • Patient with shunt heart disease
  • Patient in spontaneous or non-invasive ventilation or CPAP
  • Patient with a contraindication to volemic/fluid expansion (major cardiac dysfunction, acute renal failure)
  • Patient with cardiac arrest upper 5 min
  • ECMO
  • Postcardiotomia

Treatment and study plan

Mini-bolus

Procedure
  • First injection of 2ml/kg (saline solution)
  • Second injection of 18ml/kg (saline solution)

Primary outcomes

  1. Cardiac output variability (ΔCO)

    Time frame: 5 minutes

    Cardiac output

  2. Cardiac output variability (ΔCO)

    Time frame: 15 minutes

    Cardiac output : ΔCO (mL/min) = VES (ml)* heart rate and VES (cm3)= ITVA0(cm) * SA0 (cm2)

Secondary outcomes

  1. Heart rate variation (ΔHR)

    Time frame: 15 minutes

    Heart rate usual monitoring

  2. Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)

    Time frame: 5 minutes

    Arterial pressure invasive or not invasive monitoring according the care of patient

  3. Systolic, diastolic and mean arterial pressure variation (ΔSAP, ΔDAP, ΔMAP)

    Time frame: 15 minutes

    Arterial pressure invasive or not invasive monitoring according the care of patient

  4. Pulse pressure variation (ΔPP)

    Time frame: 5 minutes

    Pulse pressure invasive or not invasive monitoring according the care of patient

  5. Pulse pressure variation (ΔPP)

    Time frame: 15 minutes

    Pulse pressure invasive or not invasive monitoring according the care of patient

  6. Systolic ejection volume variation (ΔSEV)

    Time frame: 5 minutes

    Systolic ejection volume is measured by transthoracic echocardiography :

    VES (ml) =ITVa0*Sa0

  7. Systolic ejection volume variation (ΔSEV)

    Time frame: 15 minutes

    Systolic ejection volume is measured by transthoracic echocardiography :

    VES (ml) =ITVa0*Sa0

  8. Velocity time-index variation (ΔVTI)

    Time frame: 5 minutes

    ITVA0 is measured by transthoracic echocardiography with Doppler

  9. Velocity time-index variation (ΔVTI)

    Time frame: 15 minutes

    ITVA0 is measured by transthoracic echocardiography with Doppler

  10. Microvascular Flow Index variation (ΔMFI)

    Time frame: 5 minutes

    Microvascular Flow Index calculated by the Microscan software (Microvision)

  11. Microvascular Flow Index variation (ΔMFI)

    Time frame: 15 min

    Microvascular Flow Index calculated by the Microscan software (Microvision)

  12. Proportion Perfused Vessels variation (ΔPPV)

    Time frame: 5 minutes

    Proportion Perfused Vessels calculated by the Microscan software (Microvision)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: PRECISE

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 22, 2019
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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