Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children Using Transthoracic Echocardiography (PREDIPEN)
Primary Purpose
Fluid Therapy, Hemodynamics, Hypovolemia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echocardiographic assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Fluid Therapy focused on measuring children, critically ill, fluid therapy, fluid responsiveness, hemodynamics, hypovolemia, shock, echocardiography
Eligibility Criteria
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
Sites / Locations
- Bicetre HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Echocardiographic assessment
Arm Description
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.
Outcomes
Primary Outcome Measures
Cardiac index measured by transthoracic echocardiography
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 Outcome Measures
End-tidal carbon dioxide levels
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.
Full Information
NCT ID
NCT05054452
First Posted
June 21, 2021
Last Updated
December 6, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05054452
Brief Title
Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children Using Transthoracic Echocardiography
Acronym
PREDIPEN
Official Title
Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children and Neonates Using Transthoracic Echocardiography
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Therapy, Hemodynamics, Hypovolemia, Shock
Keywords
children, critically ill, fluid therapy, fluid responsiveness, hemodynamics, hypovolemia, shock, echocardiography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Echocardiographic assessment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Echocardiographic assessment
Intervention Description
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 Outcome Measure Information:
Title
Cardiac index measured by transthoracic echocardiography
Description
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 .
Time Frame
Through the end of the hospitalisation, a maximum of 2 months
Secondary Outcome Measure Information:
Title
End-tidal carbon dioxide levels
Description
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.
Time Frame
Through the end of the hospitalisation, a maximum of 2 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Barreault, Doctor
Phone
+33145213205
Email
simon.barreault@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Barreault, Doctor
Organizational Affiliation
Bicetre Hospital (AP-HP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bicetre Hospital
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon BARREAULT, Doctor
Phone
+33 1 45 21 32 05
Email
simon.barreault@aphp.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
18259726
Citation
Durand P, Chevret L, Essouri S, Haas V, Devictor D. Respiratory variations in aortic blood flow predict fluid responsiveness in ventilated children. Intensive Care Med. 2008 May;34(5):888-94. doi: 10.1007/s00134-008-1021-z. Epub 2008 Feb 8.
Results Reference
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Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children Using Transthoracic Echocardiography
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