Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.

Study Overview
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Brief Summary
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After cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound hypotension associated with a decrease in systemic vascular resistance. The care of this disease is based on the intravenous administration of a vasopressor, usually norepinephrine. During the recovery phase, weaning of norepinephrine, is an important step in which any lack of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.

Official Title
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Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.

Conditions
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Vasoplegic Syndrome

Intervention / Treatment
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* Drug: Norepinephrine
* Drug: Norepinephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patient ≥ 18 years Patient operated a cardiac surgery for myocardial revascularization (CABG surgery) or surgical correction of valvular or combined surgery (CABG and valve disease) or surgery the ascending aorta and cardiac surgery with vasoplegic syndrome treated by norepinephrine Signed consent Affiliation to social assurance Exclusion Criteria: Permanent atrial fibrillation Treatment with dobutamine and/or epinephrine Pregnant woman Patient under guardianship or private public law Internal pacemaker Hypothermia Patient refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: administration of norepinephrine by dynamic elastance<br>The norepinephrine weaning strategy is based on an index that reflects the vasomotor tone: dynamic arterial elastance | Drug: Norepinephrine<br>* Administration and weaning of norepinephrine is based on dynamic arterial elastance<br>* Other names: Dynamic arterial elastance;|
| Other: control administration of norepinephrine<br>The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate). | Drug: Norepinephrine<br>* The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure, cardiac output), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate).<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of treatment with norepinephrine. | Mean duration time of norepinephrine administration calculated in hours | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total dose of norepinephrine infused during the study period |  | Day 28 | 
| ICU duration of stay in day |  | Day 28 | 
| Total urine output in ml during the study period |  | Day 28 | 
| Total of crystalloid an colloid infused during the study period (ml) |  | Day 28 | 
| the rate of arterial lactate at the end of norepinephrine administration |  | Day 28 | 
| Incidence of postoperative atrial arrhythmias (Ac/Fa, Ventricular tachycardia, Ventricular flutter, Ventricular fibrillation) during the study period |  | Day 28 | 
| SOFA score | SOFA score measured at the end of norepinephrine administration | Day 28 |