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

NCT07202637 | Recruiting

• 2 other identifiers: ITV-VD2023-A02636-39
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 2

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.

Conditions

Fluid Resuscitation; Fluid Responsiveness Predictability

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

Study Arms (1)

Patients suspected of hypovolemia

Patients with suspected hypovolemia who need to be evaluated for fluid responsiveness

Drug: Fluid bolus administration

Interventions

Fluid bolus administration DRUG

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

Patients suspected of hypovolemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Nord: lead

Study Sites (2)

Service de réanimation polyvalente - Hopital Nord

Marseille 15, 13015, France

RECRUITING

Hopital Caremeau Nimes

Nîmes, 30029, France

RECRUITING

Central Study Contacts

Gary DUCLOS, MD, MSc

CONTACT

+33 4919665531; gary.duclos@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 2, 2025
• Study Start: November 7, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

FR (2)