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Clinical Trials/NCT05054452
NCT05054452
Unknown
N/A

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country76 target enrollmentJune 25, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fluid Therapy
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
76
Locations
1
Primary Endpoint
Cardiac index measured by transthoracic echocardiography
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 25, 2021
End Date
August 30, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • End-tidal carbon dioxide levels(Through the end of the hospitalisation, a maximum of 2 months)

Study Sites (1)

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