Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or After Aortic Surgery

Study Overview
=================
Brief Summary
-----------------
The MostCare system, thanks to the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy), provides new hemodynamic parameters of the cardiovascular system. The PRAM method is a noncalibrated pulse contour method which requires only an arterial line (radial or femoral). This method has been validated in various clinical conditions. Among the collected parameters, some are well known and used daily care in Intensive Care Unit (ICU), i.e. cardiac output (CO), arterial pressure, heart rate, stroke volume (SV). Others such as arterial elastance (Ea) or dicrotic pressure are more recent and merit further investigation to determine their interest in clinical practice. To date, it is rarely used to adapt therapies, mostly because of a lack of knowledge regarding the evolution of these parameters. The aim of this study is to analyze the relationship between the evolution of Arterial Elastance and fluid responsiveness after a 250 mL fluid challenge of crystalloids in 5 minutes in patients with either septic shock or in the postoperative course of a major vascular surgery. Patients will be considered fluid responders if an increase >10% of the stroke volume is observed .

Official Title
-----------------
Comparative Study on the Relationship Between Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or in the Postoperative Course of Aortic Surgery

Conditions
-----------------
Shock, Septic, Hyperlactatemia, Oliguria, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Ruptured, Aortic Stenosis

Intervention / Treatment
-----------------
* Drug: Fluid challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 18 years Septic shock (according to Sepsis-3 definition) or patients who underwent elective or emergent abdominal aortic surgery Invasive blood pressure (radial or femoral) and Mostcare monitoring Stroke volume between 20 and 50 mL/beat on the Mostcare system Indication for a fluid challenge: hypotension (Mean arterial pressure under 65mmHg) or oliguria (urine flow rate < 0,5mL/kg/h for more than 12h), mottling, hyperlactatemia > 2 mmol/l Exclusion Criteria: Age <18 years Cardiac arrhythmia Arterial wave form distortion Inappropriate identification of the dicrotic notch for any reason Refuse to consent to the study

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 |
| --- | --- |
| Septic shock<br>Patients with septic shock, according to the Sepsis 3 definition, regardless of the origin | Drug: Fluid challenge<br>* All patients who met the inclusion criteria will receive a standardised bolus of 250 ml of crystalloid in 5 minutes administered by hand with a 50 ml syringe. During the study period, hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected for 20 minutes prior to the intervention (fluid challenge), during the fluid challenge and 25 minutes after completion. The total duration of the intervention (fluid loading) is 5 min. The total duration of hemodynamic parameters recording is 60 min.<br>|
| Major vascular surgery<br>Patients who underwent elective or emergent major vascular surgery abdominal aortic surgery (open or endovascular surgery) | Drug: Fluid challenge<br>* All patients who met the inclusion criteria will receive a standardised bolus of 250 ml of crystalloid in 5 minutes administered by hand with a 50 ml syringe. During the study period, hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected for 20 minutes prior to the intervention (fluid challenge), during the fluid challenge and 25 minutes after completion. The total duration of the intervention (fluid loading) is 5 min. The total duration of hemodynamic parameters recording is 60 min.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of arterial elastance | Absolute and percentage of change in arterial elastance during the study period | 60 minutes | 
| Evolution of Stroke Volume (SV) | Absolute and percentage of change in stroke volume during the study period | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of Dicrotic Pressure (DP) value during a fluid challenge | Absolute and percentage of change in dicrotic pressure during the study period | 60 minutes | 
| Predictive factors of an increase or a decrease in the arterial elastance value | Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the arterial elastance epidemiological and clinical: age, BMI, gender, SAPS II, SOFA, Charlson comorbidity index, chronic diseases, etiology of the septic shock, acute kidney injury therapeutical: chronic treatments, vasoactive and sedative drugs, epidural analgesia, mechanical ventilation (VT, RR, PEEP) surgery: type of surgery (open or endovascular), indication, timing. indication for fluid loading: hypotension, oliguria, hyperlactatemia > 2mmol/L, mottling | 60 minutes | 
| Predictive factors of an increase or a decrease of the dicrotic pressure value | Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the dicrotic pressure | 60 minutes | 
| Evolution of norepinephrine dose: before and 60 minutes after fluid challenge | Norepinephrine dose expressed in micrograms per kilogram per minute (μg/kg/min) | 60 minutes | 
| All-cause mortality | 30 days all-cause mortality | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mostcare, Vascular surgery, Arterial Elastance, Dicrotic pressure, Fluid loading, Pressure Recording Analytical Method, Hemodynamic monitoring, Pulse contour analysis