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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02636-39 | Other Identifier | Comité de protection des personnes - Ouest I |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients suspected of hypovolemia | Patients with suspected hypovolemia who need to be evaluated for fluid responsiveness |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid bolus administration | Drug | Fluid infusion of 500 mL of a crystalloĂ¯d solution is performed for patients with signs of hypovolemia |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 crystalloĂ¯ds solution |
| 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. | 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 crystalloĂ¯ds solution |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 crystalloĂ¯ds solution |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gary DUCLOS, MD, MSc | Contact | +33 4919665531 | gary.duclos@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de réanimation polyvalente - Hopital Nord | Recruiting | Marseille 15 | 13015 | France |
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| Hopital Caremeau Nimes | Recruiting | Nîmes | 30029 | France |
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