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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.
In 2019, 45,236 cardiovascular surgical procedures were performed in France. Despite improved surgical and anesthetic management, cardiovascular surgery continues to be associated with a high mortality rate, with an estimated in-hospital death rate of 5.8%. One of the major complications associated with the patient's condition and the complexity of the surgery is post-extracorporeal circulation vasoplegia syndrome, the incidence of which is estimated at between 5 and 44%. It is associated with a high mortality rate of around 40%. This vasoplegia results in arterial hypotension and organ damage, culminating in multivisceral failure and death. This phenomenon remains poorly understood, as it is extremely complex and multifactorial (vasodilation by pathological nitric oxide production, role of neprilysin, depletion of endogenous catecholamines, alteration of the autonomic nervous system). At present, the only treatments available to manage vasoplegic syndrome are symptomatic. This vasoplegia is the consequence of alterations in microreactivity, leading to a loss of hemodynamic coherence between the macrocirculation and the microcirculation.
The aim of this work is to identify the metabolic pathways responsible for the alterations in vasoreactivity that lead to this loss of hemodynamic coherence, manifesting as hypotension at preserved cardiac output and complicating organ failure.
The investigators will select patients at risk of vasoplegic syndrome after extracorporeal circulation. A detailed assessment of their microcirculatory and macrocirculatory function, combined with blood and urine biomarker assays reflecting circulatory status at the time of sampling, will be carried out before the start of surgery, at the various key stages of cardiovascular surgery, then immediately post-operatively, at 12 hours, 24 hours, and 50 hours from the end of surgery. The monitoring of these parameters, whether or not associated with the appearance of a vasoplegic syndrome following extracorporeal circulation, will enable the investigators to better characterize the elements undergoing modification, and thus to better target the markers and metabolic pathways involved in vasoplegic syndrome, which in turn will enable the proposal of targeted curative or even preventive therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients at risk of vasoplegia syndrome after cardiac surgery | All patients at high risk of vasoplegia syndrome after cardiac surgery because they have cardiopulmonary bypass during the surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in blood neprilysin concentration | Change from baseline in plasma neprilysin concentration measured at multiple timepoints with mass spectrometry. Unit of Measure: µg/L | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiac output. | Change in cardiac output (L/min) assess using transthoracic, transesophageal ultrasound or invasive hemodynamic monitoring (FloTrac, Hemosphere,...). | From enrollment (preoperative) to 48 hours after cardiac surgery. |
| Change in mean arterial pressure |
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Inclusion Criteria:
Have at least 3 point of the following risk factors for post-body circulation vasoplegic syndrome:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hélène NOUGUE, MCU-PH | Contact | +331 56 09 25 94 | helene.nougue@aphp.fr | |
| Bernard Cholley, PUPH | Contact | +331 56 09 25 15 | bernard.cholley@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Helene NOUGUE, MCUPH | Georges Pompidou European Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georges Pompidou European Hospital | Recruiting | Paris | 75015 | France |
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| Label | URL |
|---|---|
| . Gökdemir, Begüm Nemika, et Nedim Çekmen. " Vasoplegic Syndrome and Anaesthesia: A Narrative Review ". Turkish Journal of Anaesthesiology and Reanimation 51, no 4 (1 august 2023): 280 89. | View source |
| . Vodovar, Nicolas, Marie-France Séronde, Said Laribi, Etienne Gayat, Johan Lassus, James L. Januzzi, Riadh Boukef, et al. " Elevated Plasma B-Type Natriuretic Peptide Concentrations Directly Inhibit Circulating Neprilysin Activity in Heart Failure ". JA | View source |
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Plasma
Mean arterial pressure is continuously monitor with an arterial catheter and record in mmHg. |
| From enrollment (preoperative) to 48 hours after cardiac surgery |
| 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. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| 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. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| vasopressor requirement variation | The dose of vasopressors (e.g: norepinephrine) administered is calculated in µg/kg/min, normalized to body weight and duration, to quantify circulatory support needs. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in tissue oxygen saturation. | Tissue oxygen saturation (StO₂) is measured non-invasively on the forehead using near-infrared spectroscopy (NIRS) technology and reported in percentage (%). | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in transcutaneous tissue CO₂ pressure | Transcutaneous carbon dioxide (PtCO₂) is measured in mmHg using an earlobe sensor maintained at 37°C. This reflects local tissue perfusion and CO₂ clearance. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in plasma lactate concentration. | Plasma lactate levels are measured in mmol/L from arterial blood samples. Lactate serves as a biomarker of tissue hypoperfusion and anaerobic metabolism. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in central venous oxygen saturation | Mixed venous oxygen saturation (SvO₂) is obtained with central veinous blood samples. ScvO₂ is used to detect tissue hypoperfusion. Measure in percentage (%). | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in venous-to-arterial CO₂ gap | The central venous-to-arterial CO₂ gradient is calculated in mmHg by subtracting arterial from venous pCO₂, as an indicator of tissue perfusion. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in plasma creatinine level | Plasma creatinine concentration was measured in µmol/L using standard enzymatic assays to assess renal function. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in B-type natriuretic peptide 1-32 | BNP 1-32 concentrations were measured in pmol/L from plasma samples using mass spectrometry technique to assess cardiac strain. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in B-type natriuretic peptide | Plasma B-type natriuretic peptide concentration was measured in ng/L using standard enzymatic assays to assess cardiac strain. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in NT-proBNP concentration | NT-proBNP levels are measured in ngl/L from plasma samples using standard enzymatic assays as a marker of cardiac dysfunction. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in specific NT-proBNP 1-76 concentration | NT-proBNP 1-76 fragment levels are measured in pmol/L from plasma samples using mass spectrometry as a marker of cardiac dysfunction. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in T71-glycosylated proBNP | The percentage of T71-glycosylated proBNP is determined from plasma samples using mass spectrometry, representing the ratio of glycosylated to total proBNP forms. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in vasopressin level | Plasma vasopressin levels are measured in pmol/L by immunoradiology to assess endogenous vasopressor response to circulatory stress. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in aldosterone level. | Plasma aldosterone concentrations are measured in pmol/L using immunoradiology to evaluate the activation of the renin-angiotensin-aldosterone system. | From enrollment (preoperative) to 48 hours after cardiac surgery. |
| Change in angiotensin II level | Plasma angiotensin II levels are quantified in pmol/L using mass spectrometry techniques to monitor vasoconstrictive hormonal activity and the activation of the renin-angiotensin-aldosterone system. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in endocan level | Plasma endocan concentrations are measured in pmol/L with ELISA techniques to reflect endothelial activation and inflammation in kidney and lung. | From enrollment (preoperative) to 48 hours after cardiac surgery |
| Change in 5-MTP level. | Plasma 5-MTP levels were measured in nmol/L using high-performance liquid chromatography to evaluate to evaluate systemic metabolic stress. | From enrollment (preoperative) to 48 hours after cardiac surgery |