RecruitingNot Applicable

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

France205 participantsStarted 2024-11-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fluid responsiveness

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT07202637

SponsorHospital Nord

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-11

Contact for this trial

Gary DUCLOS, MD, MSc

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

View on ClinicalTrials.gov More Fluid Resuscitation trials