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NCT Number: NCT05054452

Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children Using Transthoracic Echocardiography

Initial fluid resuscitation remains the first treatment step for most children experiencing circulatory failure and/or systemic hypotension. Only one-half of these patients respond to fluid administration by a significant increase in cardiac output. A positive fluid balance is a poor prognostic factor that increases mortality. There are few markers validated in children to assess volume reactivity by dynamic ultrasound parameters mainly based on heart-lung interaction.

In this work, the investigators propose to investigate whether dynamic parameters validated in adults, such as the superior vena caval collapsibility and the variability of cardiac output during an end-expiratory and end-inspiratory occlusion, are also reliable indicators of volume responsiveness in sedated children under controlled-mode ventilation.

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Key information

Conditions

Fluid Therapy Critical Illness Disease Attributes Hemodynamics Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bicetre Hospital

Le Kremlin-Bicêtre, 94270, France

About this study

After standardized volume expansion, patients who present an increase of cardiac index measured by transthoracic echocardiography greater than or equal to 15% of baseline measurement will be considered responders .

A previous similar study using respiratory variations in aortic blood flow to predict fluid responsiveness in ventilated children reported a ROC curve area 0.85, while the prevalence rate of circulatory failure was 50%. Given these assumptions, a sample size of 38 subjects per group (Responders / No responders) was estimated to provide a AUC equivalent. A total of 76 subjects should be included.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient < 18 years (child and neonate)
  • Sedated and mechanically ventilated under controlled-mode ventilation
  • In whom fluid administration was planned by the attending physicians

Exclusion criteria

  • High-frequency oscillatory ventilation
  • Cardiac arrhythmia
  • Congenital heart defect

Treatment and study plan

Echocardiographic assessment

Device

At baseline before standardized volume expansion, a first set of echocardiographic measurements will be performed. Then, we will perform 15-second end-expiratory and end-inspiratory occlusions. Occlusions will be separated by 1 minute to allow the cardiac index to return to its baseline value. A last set of measurements will be performed after fluid administration. Ventilatory settings and other treatments will remain unchanged during the study period.

Primary outcomes

  1. Cardiac index measured by transthoracic echocardiography

    Time frame: Through the end of the hospitalisation, a maximum of 2 months

    After fluid administration, patients who present an increase of cardiac index measured by transthoracic echocardiography greater than or equal to 15% of baseline measurement will be considered responders .

Secondary outcomes

  1. End-tidal carbon dioxide levels

    Time frame: Through the end of the hospitalisation, a maximum of 2 months

    ETCO2 measurements using sidestream microstream technology before and after fluid administration will be compared to cardiac index measured by transthoracic echocardiography, ETCO2 increment of 5% is expected in responders patients.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children and Neonates Using Transthoracic Echocardiography

Acronym: PREDIPEN

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2021
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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