BreathingVPVCNCT03780660
Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients
An observational study of Breathing, run by University Hospital, Lille at 1 site in France.
Trial summary
Volume expansion (VE) is often administered in intensive care (ICU)-patient to improve arterial oxygen delivery. Such effect is secondary to an increase in stroke volume and cardiac output. However, cardiac output increase in response to VE (fluid responsiveness) only occurs when the heart is preload-dependant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathing
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2019to 15 Sep 2021
- Phase
- Observational
- 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
Study population: Patient hospitalized in one of intensive care unit of Roger Salengro university hospital CHU Lille
Who may be able to join
- Spontaneous breathing without mechanical assistance
- Central venous catheter (superior vena cava) and monitoring of central venous pressure
- Urinary catheter and monitoring of intra-abdominal pressure
Who cannot join
- Intolerance to ventilatory manœuvre including Severe basal dyspnea/Symptomatic heart failure (pulmonary edema)
- Contraindication to passive leg raising (intracranial hypertension)
- Passive leg raising unsuitable for measuring hemodynamic response : High grade aortic insufficiency/ Poor echogenicity unsuitable to measure the velocity-time /integral of aortic blood flow/ Pregnancy/Abdominal hypertension with abdominal compartment syndrome/ Lower leg amputation
- Necessity of urgent hemodynamic therapy (within 90 min)
- Modification of hemodynamic therapy during study protocol (vascular filling, increase catecholamine dose
Trial locations and contacts
1 site in 1 country.
About this study
Volume expansion (VE) is often administered in intensive care (ICU)-patient to improve arterial oxygen delivery. Such effect is secondary to an increase in stroke volume and cardiac output. However, cardiac output increase in response to VE (fluid responsiveness) only occurs when the heart is preload-dependant. Increasing evidence of the deleterious effects of inappropriate fluid administration encourages the development of variables predicting fluid responsiveness, but few have been validated in spontaneously breathing patients.
Central venous pressure (CVP) variation in spontaneously patients during standardized or unstandardized inspiratory maneuver may represent an easy tool to predict fluid responsiveness. The hypothesise is that inspiratory maneuver may increase CVP variation in fluid responsiveness patient whereas no or few variation may reflect fluid unresponsiveness.
- Conditions
- Breathing
- Keywords
- Volume expansion, fluid responsiveness, critically ill patient, spontaneously breathing patient, central venous pressure variation
- Medical subject headings
- Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
the area under the ROC curve of the "CVPV-st" parameter
Diagnostic accuracy of the CVPV during a standardized inspiratory maneuver (CVPV-st) to predict fluid responsiveness.
Measured: an average 60 - 90 minute during the procedure
Secondary outcomes (1)
the area under the ROC curve of the "CVPV-un" parameter
Diagnostic accuracy of the CVPV during an unstandardized inspiratory maneuver (CVPV-un) to predict fluid responsiveness.
Measured: an average 60 - 90 minute during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start5 Mar 2019
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BreathingStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Preau, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780660
- Sponsor's protocol ID
- 2017_60
- Other IDs
- 2018-A01449-46
- Acronym
- VPVC
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2018
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bourel C, Durand A, Ter Schiphorst B, Martin C, Onimus T, De Jonckheere J, Howsam M, Pierre A, Favory R, Preau S. RESPIRATION-RELATED VARIATIONS IN CENTRAL VENOUS PRESSURE AS PREDICTORS OF FLUID RESPONSIVENESS IN SPONTANEOUSLY BREATHING PATIENTS. Shock. 2023 Aug 1;60(2):190-198. doi: 10.1097/SHK.0000000000002164. Epub 2023 Jul 26.
PubMed 37548683Ter Schiphorst B, Bourel C, Durand A, Ternynck C, Onimus T, Howsam M, Pierre A, De Jonckheere J, Favory R, Preau S. Validation of the inferior vena cava collapsibility as a predictive marker of fluid responsiveness in spontaneously breathing patients. Sci Rep. 2026 Apr 2;16(1):15678. doi: 10.1038/s41598-026-41826-3.
PubMed 41927624
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients
- ClinicalTrials.gov ID
- NCT03780660
- Acronym / sponsor ID
- VPVC / 2017_60
- Conditions
- Breathing
- Keywords
- Volume expansion, fluid responsiveness, critically ill patient, spontaneously breathing patient, central venous pressure variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 19 Dec 2018 (actual)
- 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.
Volume expansion (VE) is often administered in intensive care (ICU)-patient to improve arterial oxygen delivery. Such effect is secondary to an increase in stroke volume and cardiac output. However, cardiac output increase in response to VE (fluid responsiveness) only occurs when the heart is preload-dependant. Increasing evidence of the deleterious effects of inappropriate fluid administration encourages the development of variables predicting fluid responsiveness, but few have been validated in spontaneously breathing patients.
Central venous pressure (CVP) variation in spontaneously patients during standardized or unstandardized inspiratory maneuver may represent an easy tool to predict fluid responsiveness. The hypothesise is that inspiratory maneuver may increase CVP variation in fluid responsiveness patient whereas no or few variation may reflect fluid unresponsiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in one of intensive care unit of Roger Salengro university hospital CHU Lille
Key inclusion criteria (3 listed)
- Spontaneous breathing without mechanical assistance
- Central venous catheter (superior vena cava) and monitoring of central venous pressure
- Urinary catheter and monitoring of intra-abdominal pressure
Key exclusion criteria (5 listed)
- Intolerance to ventilatory manœuvre including Severe basal dyspnea/Symptomatic heart failure (pulmonary edema)
- Contraindication to passive leg raising (intracranial hypertension)
- Passive leg raising unsuitable for measuring hemodynamic response : High grade aortic insufficiency/ Poor echogenicity unsuitable to measure the velocity-time /integral of aortic blood flow/ Pregnancy/Abdominal hypertension with abdominal compartment syndrome/ Lower leg amputation
- Necessity of urgent hemodynamic therapy (within 90 min)
- Modification of hemodynamic therapy during study protocol (vascular filling, increase catecholamine dose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the area under the ROC curve of the "CVPV-st" parameter
Time frame: an average 60 - 90 minute during the procedure
Diagnostic accuracy of the CVPV during a standardized inspiratory maneuver (CVPV-st) to predict fluid responsiveness.
1 secondary outcome
the area under the ROC curve of the "CVPV-un" parameter
Time frame: an average 60 - 90 minute during the procedure
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 11 Dec 2025.
- Results publication: PubMed 37548683Bourel C, Durand A, Ter Schiphorst B, Martin C, Onimus T, De Jonckheere J, Howsam M, Pierre A, Favory R, Preau S. RESPIRATION-RELATED VARIATIONS IN CENTRAL VENOUS PRESSURE AS PREDICTORS OF FLUID RESPONSIVENESS IN SPONTANEOUSLY BREATHING PATIENTS. Shock. 2023 Aug 1;60(2):190-198. doi: 10.1097/SHK.0000000000002164. Epub 2023 Jul 26.
- Derived from this study: PubMed 41927624Ter Schiphorst B, Bourel C, Durand A, Ternynck C, Onimus T, Howsam M, Pierre A, De Jonckheere J, Favory R, Preau S. Validation of the inferior vena cava collapsibility as a predictive marker of fluid responsiveness in spontaneously breathing patients. Sci Rep. 2026 Apr 2;16(1):15678. doi: 10.1038/s41598-026-41826-3.
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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.
Sébastien Preau, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breathing, run by University Hospital, Lille 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 3 inclusion and 5 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 11 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?
the area under the ROC curve of the "CVPV-st" parameter (time frame: an average 60 - 90 minute during the procedure). 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 NCT03780660, which also lists 2 linked publications.
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 11 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.