MedTrace Logo

Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock

NCT04027699 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

  • Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit

Interventions

PROCEDURE

Mini-bolus

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

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Laurent Dupic, MD · APHP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Days
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2022-10-19
Completion
2023-02-20

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04027699 on ClinicalTrials.gov