Completed

NCT Number: NCT01965574

Preload Dependence During Prone Position In ARDS Patients

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.

Completed

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Key information

Conditions

ARDS PATIENTS WITH HEMODYNAMIC INSTABILITY

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

Age below 18
no affiliation to social security
Vena cava obstruction
previous inclusion in protocol

Treatment and study plan

Trendelenburg position

Procedure

Primary outcomes

Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence

Time frame: 1 minute after Trendelenburg position onset.

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%

Secondary outcomes

Area under ROC curve of the variation in continuous cardiac output during end-expiratory occlusion to detect preload dependence

Time frame: 15 seconds after the onset of end-expiratory occlusion

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%
Area under ROC curve of the respiratory variation in pulse pressure to detect preload dependence

Time frame: 1 minute after tidal volume increase to 8 ml/kg

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%

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Evaluation of Performance Diagnosis of Hemodynamic Parameters of Preload Dependence in ARDS Patients During Prone Position

Acronym: PRD-ARDS-PP

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Oct 18, 2013
Registry last updated: Dec 19, 2025

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.