Evaluation of the Variation of the Sub-pulmonary Velocity-time Integral to Predict Fluid Responsiveness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Nord
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Fluid bolus administration
DrugFluid infusion of 500 mL of a crystalloïd solution is performed for patients with signs of hypovolemia
Treatment groups
205 Participants
are divided into 1 treatment groupGroup A: Patients suspected of hypovolemia1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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 solution2
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.
Time frame
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 solutionSecondary outcomes
1
Sub-pulmonary VTI values description
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.
Time frame
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 solutionSponsors and contacts
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Hospital Nord
Lead sponsor
Aix Marseille Université
Sponsor institution
Source ClinicalTrials.gov