Fluid Responsiveness Assessment in Children

NCT07073859 | Completed

• 2 other identifiers: CHUBX 2023/94CER-BDX 2024 - 31
• Study Type: observational
• Target: 513
• Locations: 1 country
• Sites: 31

Brief Summary

Fluid responsiveness assessment is a major issue in intensive care. Since fewer fluid responsiveness tests can be used children, fluid expansion prescriptions are often based on professional practices due to the absence of guidelines. This observational, cross-sectional, multicentric study is an evaluation of professional practices regarding fluid expansions in pediatric intensive care units. The main objective will be to describe the proportion of fluid expansions that are administered following an assessment of fluid responsiveness.

Conditions

Circulatory Failure; Shock State

Keywords

Circulatory failure; Fluid therapy; Fluid responsiveness; Critical care

Outcome Measures

Primary Outcomes (1)

• Percentage of fluid expansions preceded by a fluid responsiveness assessment

  It will be collected by auditing the prescribing physician after each fluid expansion administration.

  Day 0

Secondary Outcomes (14)

• Percentage of each fluid responsiveness test used

  Day 0

• Percentage of fluid responsiveness tests used with all of the validity criteria

  Day 0

• Mean volume of fluid expansions

  Day 0

• Mean duration of fluid expansions

  Day 0

• Percentage of fluid expansion efficacy evaluations based on cardiac output measurement

  Day 0

Interventions

Fluid expansion OTHER

Data will be collected retrospectively, after fluid expansion administration, by the prescribing physician through. These data will be collected from standard monitoring and/or from the patient's medical record. Data will therefore only be collected at a single point in time.

Eligibility Criteria

• Age: 37 Weeks - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Fluid expansion prescriptions in pediatric ICU (PICU)

You may qualify if:

• Age less than or equal to 15 years old
• Hospitalization in a pediatric intensive care unit
• Prescription by the attending physician of a fluid expansion in order to increase cardiac output and restore the patient's circulatory function, which the physician has judged to be impaired. Fluid expansion is defined as a rapid intravenous infusion (\<30min) of a high volume (\>10ml/kg or 250ml) of an isotonic crystalloid solution, albumin, or fresh frozen plasma. The decision to administer a fluid expansion and the type of fluid administered are left to the discretion of the physician (current practice).

You may not qualify if:

• Patient less than 37 weeks' corrected gestational age
• Univentricular circulatory physiology
• Mechanical circulatory support
• Opposition of the patient or his/her parents or legal guardians to data collection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (31)

Site Sud - CHU d'Amiens Picardie

Amiens, France, 80054, France

Location

CHU d'Angers

Angers, France, 49933, France

Location

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, France, 33076, France

Location

Hôpital Morvan - CHU de Brest

Brest, France, 29200, France

Location

Hôpital Louis Pradel - Hospices Civils de Lyon

Bron, France, 69500, France

Location

CHU Caen Normandie

Caen, France, 14000, France

Location

Site Estaing - CHU de Clermont-Ferrand

Clermont-Ferrand, France, 63100, France

Location

Hôpital d'Enfants - CHU de Dijon-Bourgogne

Dijon, France, 21000, France

Location

Hôpital Raymond Poincaré - Assistance Publique - Hôpitaux de Paris

Garches, France, 92380, France

Location

Hôpital Couple-Enfant -Hôpital Couple-Enfant

Grenoble, France, 38043, France

Location

Hôpital Felix Guyon (Saint Denis) - CHU de la Réunion

La Réunion, France, 97400, France

Location

Hôpital Kremlin Bicêtre - Assistance Publique - Hôpitaux de Paris

Le Kremlin-Bicêtre, France, 94270, France

Location

Hôpital Marie-Lannelongue

Le Plessis-Robinson, France, 92350, France

Location

Hôpital Jeanne de Flandre - CHRU de Lille

Lille, France, 59000, France

Location

Hôpital de la mère et de l'enfant - CHU de Limoges

Limoges, France, 87042, France

Location

Hôpital de la Timone - Assistance Publique - Hôpitaux de Marseille

Marseille, France, 13385, France

Location

Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, France, 34295, France

Location

Hôpital mère-enfant - CHU de Nantes

Nantes, France, 44093, France

Location

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France, 06200, France

Location

Hôpital Trousseau - Assistance Publique - Hôpitaux de Paris

Paris, France, 75012, France

Location

Hôpital Necker-Enfants Malades - Assistance Publique - Hôpitaux de Paris

Paris, France, 75015, France

Location

Hôpital Robert Debré - Assistance Publique - Hôpitaux de Paris

Paris, France, 75019, France

Location

CHU de Bordeaux - Hôpital Cardiologique Haut-Lévêque

Pessac, France, 33604, France

Location

La Milétrie - CHU de Poitiers

Poitiers, France, 86000, France

Location

Hôpital d'enfants - American Memorial Hospital - CHU de Reims

Reims, France, 51100, France

Location

Hôpital Sud - CHU de Rennes

Rennes, France, 35033, France

Location

Hôpital Charles-Nicolle - CHU de Rouen

Rouen, France, 76000, France

Location

Hôpital de Hautepierre - Hôpitaux Universitaires de Strasbourg

Strasbourg, France, 67091, France

Location

Hôpital des enfants - Hôpital des enfants

Toulouse, France, 31300, France

Location

Hôpital Clocheville - CHRU de Tours

Tours, France, 37000, France

Location

Hôpitaux de Brabois - CHRU de Nancy

Vandœuvre-lès-Nancy, France, 54500, France

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: March 19, 2024
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2024
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

FR (31)