NCT04027699: PRECISE

Predictive Mini-bolus Fluid Responsiveness in Pediatric Septic Shock

Completed NA Last updated 20 November 2025

What this trial tests

NA trial testing Mini-bolus in Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit in 11 participants. Completed in 20 February 2023.

Timeline

23 February 2021

Primary endpoint
19 October 2022

20 February 2023

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	23 February 2021
Primary completion	19 October 2022
Estimated completion	20 February 2023
Sites	1 location across France

Drugs / interventions tested

• Mini-bolus

Conditions studied

• Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit — all drugs for Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 28 Days to 15, any sex, with Severe Sepsis or Septic Shock in Pediatric Intensive Care Unit. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.