Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to show that the variation of the subaortic velocity time integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is predictive of response to filling (defined as an increase in aortic velocity time integral measured by transthoracic ultrasound over 15% after administration of 500 cc of normal saline over 15 minutes) in non-ventilated shock patients.

Detailed Description
-----------------
The secondary objectives of this study include: To determine the sensitivity and specificity of the variation of the velocity time integral after administration of 100 cc of normal saline over 1 minute (ΔITV100) to predict the response to the filling. To study the inter-observer variation of ΔITV100 measurement. To compare ΔITV100 to other clinical and radiological parameters for predicting response to filling (initial value of the subaortic velocity time integral, variation in mitral E wave, E / A, respiratory variation of the diameter of the inferior vena cava, marbling clinical evolution score.

Official Title
-----------------
Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock

Conditions
-----------------
Shock, Circulatory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan Systolic blood pressure (SBP) < 90 mmHg Signs of inadequate cardiac output: urine output <0.5 ml / kg / h for more than two hours, hyperlactataemia Requires amines to maintain an SBP ≥ 90 mmHg or inability to lower amines or requires an increase in amines Exclusion Criteria: The patient is participating in another study The patient is in an exclusion period determined by a previous study The patient is under judicial protection, under tutorship or curatorship The patient (or his/her person-of-trust) refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant, parturient, or breastfeeding The patients has a contraindication for a treatment necessary for this study Cardiogenic shock Acute pulmonary edema Moribund patient Non echogenic patient Patient with cardiac arrhythmia Patients for whom the passive leg raising test is contraindicated (hyper intra-abdominal pressure, pelvic or lower limb trauma)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The study population<br>Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2) |  | baseline; 26 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change if the subaortic velocity time integral after a passive leg raising trial (cm^2) |  | baseline; 15 minutes | 
| Change in heart rate after the mini-fluid challenge | (bpm,%) | baseline; 26 minutes | 
| Change in mean arterial pressure after the mini-fluid challenge (mmHg) |  | baseline; 26 minutes | 
| Change in mitral E wave (cm / s) after the mini-fluid challenge |  | baseline; 26 minutes | 
| Change in the E/A ratio after the mini-fluid challenge |  | baseline; 26 minutes | 
| Change in the Marbrure clinical score after the mini-fluid challenge |  | baseline; 26 minutes | 
| Change in lower vena cava diameter | (DiameterMax-DiameterMin) / DiameterMax (cm;%) | baseline; 8 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mini fluid challenge, subaortic velocity time integral