Preload Dependence During Prone Position In ARDS Patients
PRD-ARDS-PP
Evaluation of Performance Diagnosis of Hemodynamic Parameters of Preload Dependence in ARDS Patients During Prone Position
1 other identifier
interventional
33
1 country
1
Brief Summary
Preload dependence assessment is difficult during prone position, and to date, no hemodynamic parameters have been validated to rationalize fluid loading in that position. This study aims to validate several hemodynamic parameters, using continuous cardiac output by pulse contour analysis and transpulmonary thermodilution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 16, 2013
CompletedFirst Posted
Study publicly available on registry
October 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedDecember 19, 2025
December 1, 2025
3.3 years
October 16, 2013
December 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence
Preload dependence is assessed by the response in cardiac output to a 500 mL fluid loading, and is deemed positive if cardiac output increase by at least 15%
1 minute after Trendelenburg position onset.
Secondary Outcomes (2)
Area under ROC curve of the variation in continuous cardiac output during end-expiratory occlusion to detect preload dependence
15 seconds after the onset of end-expiratory occlusion
Area under ROC curve of the respiratory variation in pulse pressure to detect preload dependence
1 minute after tidal volume increase to 8 ml/kg
Study Arms (1)
Single arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- ARDS patient
- mechanically ventilated in prone position
- sedated and paralyzed
- with continuous cardiac output monitoring by transpulmonary thermodilution and pulse contour analysis
- fluid loading as indicated by attending physician
You may not qualify if:
- Age below 18
- no affiliation to social security
- Vena cava obstruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital de la Croix Rousse
Lyon, 69004, France
Related Publications (1)
Yonis H, Bitker L, Aublanc M, Perinel Ragey S, Riad Z, Lissonde F, Louf-Durier A, Debord S, Gobert F, Tapponnier R, Guerin C, Richard JC. Change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in the prone position under protective ventilation. Crit Care. 2017 Dec 5;21(1):295. doi: 10.1186/s13054-017-1881-0.
PMID: 29208025RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Christophe RICHARD
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2013
First Posted
October 18, 2013
Study Start
October 1, 2013
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
December 19, 2025
Record last verified: 2025-12