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

Recruiting

• Conditions: Fluid Resuscitation; Fluid Responsiveness Predictability
• Interventions: Drug: Fluid bolus administration

• Registration Number: NCT07202637
• Lead Sponsor: Hospital Nord

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-07
• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2026-11
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 205

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients suspected of hypovolemia	Fluid bolus administration	Patients with suspected hypovolemia who need to be evaluated for fluid responsiveness

Primary Outcome Measures

Name	Time	Method
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	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	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (2)

Service de réanimation polyvalente - Hopital Nord; 🇫🇷 Marseille 15, France

Hopital Caremeau Nimes; 🇫🇷 Nîmes, France