Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%)

Study Overview
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Brief Summary
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Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not been showed until now when LVEF is altered.

Official Title
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Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%): Sensibility and Specificity of Respiratory Variations of Pulse Pressure (∆PP), Photoplethysmography (∆POP), Perfusion Index (PVI), Before and After Fluid Expansion.

Conditions
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Ventricular Dysfunction

Intervention / Treatment
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* Procedure: cardiac surgery for ventricular dysfunction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients >18 years old in the immediate post-operative period after cardiac surgery ASA 1 - 3 Pre-operative LVEF≤45% Sedated with Ramsay score: 6 Mechanically ventilated with tidal volume at 8ml/kg, PEEP at 0mmHg, I/Eat 0,5 With hemodynamic failure: SAP≤90mmHg and/or inotropic or vasoactive drug started in the operating room and/or clinical sign of shock and/or CI ≤2,3l/min/m2 Affiliation to Health Insurance Consent form signed Exclusion Criteria: Cardiac arrhythmia: frequent atrial or ventricular extra systoles, atrial fibrillation Intracardiac shunt Weight less than 50 kg History of central nervous system illness Pulmonary oedema (clinical and/or radiological and/or wedge pressure>18mmHg) Right ventricular failure suspected (CVP> wedge pressure) or diagnosed (trans thoracic and/or transesophageal echocardiography) Acute kidney injury with oligoanuria Severe post operative bleeding (chest tubes volume of >200ml/h for 3 hours or more) Severe hypoxia (PaO2/FIO2< 100) Administrative control (patient under guardianship or curatorship)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ventricular dysfunction<br>cardiac surgery for ventricular dysfunction | Procedure: cardiac surgery for ventricular dysfunction<br>* For each included patient during the immediate post operative period, hemodynamic variables will be recorded (continuous arterial pressure, ECG, photoplethysmographic curve, CVP, wedge pressure, respiratory pressure), at rest (proclive 45°), during fluid expansion (physiological saline).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of ∆PP, ∆POP, PVI and Cardiac index (CI) | To assess the sensibility and specificity of ∆PP, ∆POP, PVI, after fluid expansion in case of hemodynamic failure in the immediate post-operative period after cardiac surgery, when pre-operative LVEF is altered. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure. | Secondary objectives : Early optimization of hemodynamics after cardiac surgery, To determine optimal threshold for ∆PP, ∆POP and PVI, To compare dynamic (∆PP, ∆POP and PVI) with static (central venous pressure: CVP, wedge pressure) indices | 2 hours |