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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit

Treatments

Procedure: Mini-bolus

Study type

Interventional

Funder types

Other

Identifiers

NCT04027699
PRECISE

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

28 days to 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

Mini-bolus
Experimental group
Description:
* First injection of 2ml/kg (saline solution) * Second injection of 18ml/kg (saline solution)
Treatment:
Procedure: Mini-bolus

Trial contacts and locations

1

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Central trial contact

Pierre-Louis Léger, MD-PhD; Aminata TRAORE

Data sourced from clinicaltrials.gov

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