Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock

NCT ID: NCT04027699

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2023-02-20

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.

Conditions

Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mini-bolus

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

Group Type: EXPERIMENTAL

Mini-bolus

Intervention Type: PROCEDURE

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

Interventions

Mini-bolus

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Dupic, MD

Role: STUDY_CHAIR

APHP

Locations

Hôpital Necker Enfants-Malades

Paris, , France

Countries

France

Other Identifiers

PRECISE

Identifier Type: -

Identifier Source: org_study_id