ARDS PATIENTS WITH HEMODYNAMIC INSTABILITYPRD-ARDS-PPNCT01965574
Preload Dependence During Prone Position In ARDS Patients
A study testing Trendelenburg position in people with ARDS PATIENTS WITH HEMODYNAMIC INSTABILITY, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS PATIENTS WITH HEMODYNAMIC INSTABILITY
- What is being tested?
- Trendelenburg position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age below 18
- no affiliation to social security
- Vena cava obstruction
- previous inclusion in protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Performance Diagnosis of Hemodynamic Parameters of Preload Dependence in ARDS Patients During Prone Position
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.
- Being tested
- Trendelenburg position
- Keywords
- ARDS - FLUID LOADING - PRELOAD DEPENDENCE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendelenburg positionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Procedure: Trendelenburg position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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
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%
Measured: 15 seconds after the onset of end-expiratory occlusion
Area under ROC curve of the respiratory variation in pulse pressure 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%
Measured: 1 minute after tidal volume increase to 8 ml/kg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDS PATIENTS WITH HEMODYNAMIC INSTABILITYStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Christophe RICHARD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965574
- Sponsor's protocol ID
- 2012.783
- Acronym
- PRD-ARDS-PP
- Status last verified
- Dec 2025
- First submitted
- 16 Oct 2013
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29208025
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance Diagnosis of Hemodynamic Parameters of Preload Dependence in ARDS Patients During Prone Position
- ClinicalTrials.gov ID
- NCT01965574
- Acronym / sponsor ID
- PRD-ARDS-PP / 2012.783
- Keywords
- ARDS - FLUID LOADING - PRELOAD DEPENDENCE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Procedure: Trendelenburg position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Age below 18
- no affiliation to social security
- Vena cava obstruction
- previous inclusion in protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trendelenburg position | Procedure or surgery | Single arm |
Primary outcome
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%
2 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 29208025Yonis 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Christophe RICHARD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trendelenburg position in people with ARDS PATIENTS WITH HEMODYNAMIC INSTABILITY, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01965574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.