Fluid ResuscitationNCT07202637
Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness
An observational study of Fluid Resuscitation and Fluid Responsiveness Predictability, run by Hospital Nord at 2 sites in France.
Trial summary
Fluid administration is the first-line treatment in hypovolemic states in critically ill patients. Prediction of fluid responsiveness is possible with echocardiography by assessing the variation of the sub-aortic velocity-time integral (AoVTI) during a passive leg raising test (PLR) or Mini-fluid challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Resuscitation, Fluid Responsiveness Predictability
- What is being tested?
- Fluid bolus administration
- Type of treatment
- Injection or infusion
- How many people
- 205 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Nov 2024to 6 Feb 2026
- 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: In patients with suspected hypovolemia, a cardiac ultrasound is performed as part of routine care. A patient is eligible if it is possible to measure both sub-aortic VTI (gold standard) and sub-pulmonary VTI in one of the two echocardiographic windows described in the literature (parasternal short-axis or subcostal).
Who may be able to join
- Patient with measurable sub-pulmonary VTI in at least one of the two windows: parasternal short-axis or subcostal.
- Patient with measurable sub-aortic VTI in apical 4-chamber view before and after PLR maneuver.
- Patient with suspected hypovolemia or whose hemodynamic status justifies vasopressor infusion.
Who cannot join
- Severe left ventricular dysfunction defined by left ventricular ejection fraction (LVEF) < 30%.
- Severe right ventricular dysfunction defined by TAPSE < 12 mm.
- Cardiac arrhythmia or atrial fibrillation.
- Abdominal compartment syndrome.
- Amputation of one or both lower limbs.
- Intracranial hypertension.
- Pregnant women (ruled out by systematic pregnancy test at ICU admission).
- Minors.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de réanimation polyvalente - Hopital Nord
Marseille 15, 13015
Hopital Caremeau Nimes
Nîmes, 30029
About this study
Official title: Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness Prospective Observational Study
Fluid administration is the first-line treatment in hypovolemic states in critically ill patients. Prediction of fluid responsiveness is possible with echocardiography by assessing the variation of the sub-aortic velocity-time integral (AoVTI) during a passive leg raising test (PLR) or Mini-fluid challenge. However, VTI-Ao measurement is not feasible in all patients due to poor echogenicity. Validation of new fluid-responsiveness indices may facilitate the evaluation in this patient population. Among the available indices, variation of the sub-pulmonary VTI is a potential criterion.
- Being tested
- Fluid bolus administration
- Keywords
- fluid responsiveness, echocardiography, Passive Leg Raising, Mini Fluid Challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid bolus administrationDrug
Fluid infusion of 500 mL of a crystalloïd solution is performed for patients with signs of hypovolemia
| Study group | Role | What they receive |
|---|---|---|
| Patients suspected of hypovolemia | Patients with suspected hypovolemia who need to be evaluated for fluid responsiveness Receives: Drug: Fluid bolus administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness
Echocardiographic measurement of subaortic velocity time integral (AoVTI) in apical 5-chambers view is performed before (T0 = Baseline) and within 10 mins (T2) after fluid administration.
An increase of 15% or more of AoVTI after fluid administration of 500mL of a crystalloids solution compared to baseline define fluid responsiveness.
Measured: T0 : baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution
Ability of sub-pulmonary VTI variation to predict fluid responsiveness
The sub-pulmonary VTI variation (in %) between T0 and T1 is mesured with echocardiography from a transthoracic view (short axis parasternal and sub costal views depending of patient's echogenicity)
Sub-pulmonary VTI variation ability to detect fluid responsiveness is assessed by constructing ROC curves to detect the best cut-off.
Measured: T0 : Baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution
Secondary outcomes (1)
Sub-pulmonary VTI values description
To describe values of Sub-pulmonary VTI (cm) during the time frame measured with echocardiography in subcostal view and / or in parasternal short axis view depending of patient's echogenicity.
Measured: T0 : baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start7 Nov 2024
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResuscitationStudies of the same condition, open and under way.
- 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
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary DUCLOS, Aix Marseille Université
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202637
- Sponsor's protocol ID
- ITV-VD
- Other IDs
- 2023-A02636-39
- Status last verified
- Jul 2026
- First submitted
- 12 Sep 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07202637
- Acronym / sponsor ID
- ITV-VD
- Keywords
- fluid responsiveness, echocardiography, Passive Leg Raising, Mini Fluid Challenge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Hospital NordUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 2 Oct 2025 (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.
Fluid administration is the first-line treatment in hypovolemic states in critically ill patients. Prediction of fluid responsiveness is possible with echocardiography by assessing the variation of the sub-aortic velocity-time integral (AoVTI) during a passive leg raising test (PLR) or Mini-fluid challenge. However, VTI-Ao measurement is not feasible in all patients due to poor echogenicity. Validation of new fluid-responsiveness indices may facilitate the evaluation in this patient population. Among the available indices, variation of the sub-pulmonary VTI is a potential criterion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suspected of hypovolemia | – | Drug: Fluid bolus administrationPatients with suspected hypovolemia who need to be evaluated for fluid responsiveness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In patients with suspected hypovolemia, a cardiac ultrasound is performed as part of routine care. A patient is eligible if it is possible to measure both sub-aortic VTI (gold standard) and sub-pulmonary VTI in one of the two echocardiographic windows described in the literature (parasternal short-axis or subcostal).
Key inclusion criteria (3 listed)
- Patient with measurable sub-pulmonary VTI in at least one of the two windows: parasternal short-axis or subcostal.
- Patient with measurable sub-aortic VTI in apical 4-chamber view before and after PLR maneuver.
- Patient with suspected hypovolemia or whose hemodynamic status justifies vasopressor infusion.
Key exclusion criteria (8 listed)
- Severe left ventricular dysfunction defined by left ventricular ejection fraction (LVEF) < 30%.
- Severe right ventricular dysfunction defined by TAPSE < 12 mm.
- Cardiac arrhythmia or atrial fibrillation.
- Abdominal compartment syndrome.
- Amputation of one or both lower limbs.
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 |
|---|---|---|
| Fluid bolus administrationFluid infusion of 500 mL of a crystalloïd solution is performed for patients with signs of hypovolemia | Drug | Patients suspected of hypovolemia |
Primary outcome
Fluid responsiveness
Time frame: T0 : baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution
Echocardiographic measurement of subaortic velocity time integral (AoVTI) in apical 5-chambers view is performed before (T0 = Baseline) and within 10 mins (T2) after fluid administration. An increase of 15% or more of AoVTI after fluid administration of 500mL of a crystalloids solution compared to baseline define fluid responsiveness.
Ability of sub-pulmonary VTI variation to predict fluid responsiveness
Time frame: T0 : Baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution
The sub-pulmonary VTI variation (in %) between T0 and T1 is mesured with echocardiography from a transthoracic view (short axis parasternal and sub costal views depending of patient's echogenicity) Sub-pulmonary VTI variation ability to detect fluid responsiveness is assessed by constructing ROC curves to detect the best cut-off.
1 secondary outcome
Sub-pulmonary VTI values description
Time frame: T0 : baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution
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 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Resuscitation and Fluid Responsiveness Predictability, run by Hospital Nord at 2 sites 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 8 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 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Fluid responsiveness (time frame: T0 : baseline T1 : 60 to 90 after passive legs raising manoeuver or mini fluid challenge T2 : within 10 mins after fluid infusion of 500mL of crystalloïds solution). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.