About this trial
This research focuses on understanding the vasoplegic syndrome after cardiac surgery under extracorporeal circulation and in the aftermath of your surgery in the ICU.
The investigators evaluate variations in a number of clinical and biological parameters during cardiac surgery and in the 48 hours following resuscitation. In addition to all the monitors investigators usually use to monitor vital parameters during this type of procedure, investigators use sensors placed on the skin at the earlobe and palm of the hand to assess the quality of blood circulating in the body.
The investigators would like to know if these observations help us to better understand the vasoplegic syndrome (persistent drop in blood pressure requiring the administration of medication to maintain normal blood pressure), a known but poorly understood complication following cardiac surgery under extracorporeal circulation. Extracorporeal circulation is the pump that keeps the blood circulating in your body when the heart is stopped while the surgeon works on the heart.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Acute or chronic heart failure with left ventricular ejection fraction< 40% (1 pt)
Complex cardiac surgery ( 2 pts)
Cardiovascular risk factors with a EuroSCORE> 4% (1 pt)
Chronic Kidney Disease Stage 4
Disqualifiers
Heart transplantation
Pre-operative hemodynamic instability
Pregnant women
Age <18
Trial population
Study population is all patients with risk factors at post operative vasoplegia syndrome (3 points or more in "inclusion criteria") who will have a cardiac surgery in the Georges Pompidou European Hospital
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in blood neprilysin activity.
Change from baseline in plasma neprilysin enzymatic activity measure at multiple timepoints with fluorimetry. Unit of Measure: pmol/mL/min
Change in blood neprilysin concentration
Change from baseline in plasma neprilysin concentration measured at multiple timepoints with mass spectrometry. Unit of Measure: µg/L
Secondary outcomes
Change in cardiac output.
Change in cardiac output (L/min) assess using transthoracic, transesophageal ultrasound or invasive hemodynamic monitoring (FloTrac, Hemosphere,...).
Change in mean arterial pressure
Mean arterial pressure is continuously monitor with an arterial catheter and record in mmHg.
Change un skin marbling score
Marbling is assessed using a validated ordinal scale (from 0: no marbling to 5: intense marbling) on the anterior knee surface. Score changes is used to evaluate peripheral perfusion and microcirculatory system.
Change in skin recoloration time.
Skin recoloration time is measured in seconds after fingertip pressure and a return to the initial skin color. This time reflects peripheral perfusion and microcirculatory status.
Sponsors and contacts
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