Actively Recruiting
Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness Prospective Observational Study
Led by Hospital Nord · Updated on 2025-10-02
205
Participants Needed
2
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new ways to predict fluid responsiveness in critically ill patients suspected of hypovolemia, a condition where the body has low blood volume. The study focuses on measuring the variation of the sub-pulmonary velocity-time integral (VTI) using echocardiography during tests like the passive leg raising maneuver or a mini-fluid challenge. This observational study aims to validate these new indices since traditional sub-aortic VTI measurements are not always possible due to poor echogenicity. The study involves patients suspected of low blood volume who require evaluation for fluid responsiveness. During the study, patients receive a fluid infusion of 500 mL of a crystalloid solution if signs of hypovolemia are present. Measurements of sub-pulmonary VTI are taken at baseline, after the passive leg raising maneuver or mini-fluid challenge, and within 10 minutes after fluid infusion to assess its ability to predict fluid responsiveness. Participants will undergo echocardiographic measurements at specific time points and monitoring during fluid administration. Researchers will assess fluid responsiveness based on changes observed in VTI measurements. The main outcomes include fluid responsiveness and the ability of sub-pulmonary VTI variation to predict it. Safety and clinical status will also be monitored throughout the study, which is expected to continue until May 2027.
CONDITIONS
Brief Title
Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 passive leg raising maneuver.
- Patient with suspected hypovolemia or whose hemodynamic status justifies vasopressor infusion.
- Age 18 years or older.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within a single day
Participants are monitored to evaluate fluid responsiveness through measurements taken before and after fluid infusion and passive leg raising maneuvers.
1 to 3 visits depending on assessments
Trial Site Locations
Total: 2 locations
1
Service de réanimation polyvalente - Hopital Nord
Marseille 15, France, 13015
Actively Recruiting
2
Hopital Caremeau Nimes
Nîmes, France, 30029
Actively Recruiting
Research Team
G
Gary DUCLOS, MD, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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