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

NCT ID: NCT07202637

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-07

Study Completion Date

2027-05-31

Brief Summary

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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

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Conditions

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Fluid Resuscitation Fluid Responsiveness Predictability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients suspected of hypovolemia

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

Fluid bolus administration

Intervention Type DRUG

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

Interventions

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Fluid bolus administration

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Nord

OTHER

Sponsor Role lead

Responsible Party

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Gary DUCLOS

MD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Service de réanimation polyvalente - Hopital Nord

Marseille 15, , France

Site Status RECRUITING

Hopital Caremeau Nimes

Nîmes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gary DUCLOS, MD, MSc

Role: CONTACT

+33 4919665531

Facility Contacts

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Gary DUCLOS

Role: primary

+33 491965531

Laurent Muller, MD, phD

Role: primary

+33 4 66 68 68 19

Other Identifiers

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2023-A02636-39

Identifier Type: OTHER

Identifier Source: secondary_id

ITV-VD

Identifier Type: -

Identifier Source: org_study_id

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