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Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness

Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07202637
Enrollment
205
Registered
2025-10-02
Start date
2024-11-07
Completion date
2026-02-06
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Responsiveness Predictability, Fluid Resuscitation

Keywords

fluid responsiveness, echocardiography, Passive Leg Raising, Mini Fluid Challenge

Brief 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. 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.

Interventions

Fluid infusion of 500 mL of a crystalloïd solution is performed for patients with signs of hypovolemia

Sponsors

Hospital Nord
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Fluid responsivenessT0 : 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 solutionEchocardiographic 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 responsivenessT0 : 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 solutionThe 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.

Secondary

MeasureTime frameDescription
Sub-pulmonary VTI values descriptionT0 : 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 solutionTo 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026