[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597532":3},{"organization":4,"outcomesModule":7,"designInfo":82,"detailedDescription":85,"studyPopulation":86,"armGroups":87,"interventions":81,"overallOfficials":91,"centralContacts":96,"locations":106,"responsibleParty":124,"collaborators":81,"id":127,"slug":81,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":135,"minAge":136,"maxAge":81,"enrollmentInfo":137,"targetDuration":81,"studyType":140,"phases":81,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":108,"whyStopped":81,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"European Georges Pompidou Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":81},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in blood neprilysin activity.","Change from baseline in plasma neprilysin enzymatic activity measure at multiple timepoints with fluorimetry.\n\nUnit of Measure: pmol\u002FmL\u002Fmin","From enrollment (preoperative) to 48 hours after cardiac surgery",{"measure":14,"description":15,"timeFrame":12},"Change in blood neprilysin concentration","Change from baseline in plasma neprilysin concentration measured at multiple timepoints with mass spectrometry.\n\nUnit of Measure: µg\u002FL",[17,21,24,27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,78],{"measure":18,"description":19,"timeFrame":20},"Change in cardiac output.","Change in cardiac output (L\u002Fmin) assess using transthoracic, transesophageal ultrasound or invasive hemodynamic monitoring (FloTrac, Hemosphere,...).","From enrollment (preoperative) to 48 hours after cardiac surgery.",{"measure":22,"description":23,"timeFrame":12},"Change in mean arterial pressure","Mean arterial pressure is continuously monitor with an arterial catheter and record in mmHg.",{"measure":25,"description":26,"timeFrame":12},"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.",{"measure":28,"description":29,"timeFrame":12},"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.",{"measure":31,"description":32,"timeFrame":12},"vasopressor requirement variation","The dose of vasopressors (e.g: norepinephrine) administered is calculated in µg\u002Fkg\u002Fmin, normalized to body weight and duration, to quantify circulatory support needs.",{"measure":34,"description":35,"timeFrame":12},"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 (%).",{"measure":37,"description":38,"timeFrame":12},"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.",{"measure":40,"description":41,"timeFrame":12},"Change in plasma lactate concentration.","Plasma lactate levels are measured in mmol\u002FL from arterial blood samples. Lactate serves as a biomarker of tissue hypoperfusion and anaerobic metabolism.",{"measure":43,"description":44,"timeFrame":12},"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 (%).",{"measure":46,"description":47,"timeFrame":12},"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.",{"measure":49,"description":50,"timeFrame":12},"Change in plasma creatinine level","Plasma creatinine concentration was measured in µmol\u002FL using standard enzymatic assays to assess renal function.",{"measure":52,"description":53,"timeFrame":12},"Change in B-type natriuretic peptide 1-32","BNP 1-32 concentrations were measured in pmol\u002FL from plasma samples using mass spectrometry technique to assess cardiac strain.",{"measure":55,"description":56,"timeFrame":12},"Change in B-type natriuretic peptide","Plasma B-type natriuretic peptide concentration was measured in ng\u002FL using standard enzymatic assays to assess cardiac strain.",{"measure":58,"description":59,"timeFrame":12},"Change in NT-proBNP concentration","NT-proBNP levels are measured in ngl\u002FL from plasma samples using standard enzymatic assays as a marker of cardiac dysfunction.",{"measure":61,"description":62,"timeFrame":12},"Change in specific NT-proBNP 1-76 concentration","NT-proBNP 1-76 fragment levels are measured in pmol\u002FL from plasma samples using mass spectrometry as a marker of cardiac dysfunction.",{"measure":64,"description":65,"timeFrame":12},"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.",{"measure":67,"description":68,"timeFrame":12},"Change in vasopressin level","Plasma vasopressin levels are measured in pmol\u002FL by immunoradiology to assess endogenous vasopressor response to circulatory stress.",{"measure":70,"description":71,"timeFrame":20},"Change in aldosterone level.","Plasma aldosterone concentrations are measured in pmol\u002FL using immunoradiology to evaluate the activation of the renin-angiotensin-aldosterone system.",{"measure":73,"description":74,"timeFrame":12},"Change in angiotensin II level","Plasma angiotensin II levels are quantified in pmol\u002FL using mass spectrometry techniques to monitor vasoconstrictive hormonal activity and the activation of the renin-angiotensin-aldosterone system.",{"measure":76,"description":77,"timeFrame":12},"Change in endocan level","Plasma endocan concentrations are measured in pmol\u002FL with ELISA techniques to reflect endothelial activation and inflammation in kidney and lung.",{"measure":79,"description":80,"timeFrame":12},"Change in 5-MTP level.","Plasma 5-MTP levels were measured in nmol\u002FL using high-performance liquid chromatography to evaluate to evaluate systemic metabolic stress.",null,{"allocation":81,"interventionModel":81,"interventionModelDescription":81,"primaryPurpose":81,"observationalModel":83,"timePerspective":84,"maskingInfo":81},"COHORT","PROSPECTIVE","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.\n\nThe 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.\n\nThe 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.","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",[88],{"label":89,"type":81,"description":90,"interventionNames":81},"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",[92],{"name":93,"affiliation":94,"role":95},"Helene NOUGUE, MCUPH","Georges Pompidou European Hospital","PRINCIPAL_INVESTIGATOR",[97,102],{"name":98,"role":99,"phone":100,"phoneExt":81,"email":101},"Hélène NOUGUE, MCU-PH","CONTACT","+331 56 09 25 94","helene.nougue@aphp.fr",{"name":103,"role":99,"phone":104,"phoneExt":81,"email":105},"Bernard Cholley, PUPH","+331 56 09 25 15","bernard.cholley@aphp.fr",[107],{"facility":94,"status":108,"city":109,"state":81,"zip":110,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"RECRUITING","Paris","75015","France","FR",{"type":114,"coordinates":115},"Point",[116,117],2.3488,48.85341,{"lat":117,"lon":116},[120,121,123],{"name":93,"role":99,"phone":100,"phoneExt":81,"email":101},{"name":122,"role":99,"phone":104,"phoneExt":81,"email":105},"Bernard CHOLLEY, PUPH",{"name":93,"role":95,"phone":81,"phoneExt":81,"email":81},{"type":95,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":81,"oldOrganization":81},"NOUGUE Hélène","Investigator Coordinator","100597532",false,"NCT07059715","Mic Mac: Micro- and Macrocirculatory Assessment During Cardiac Surgery in Patients at Risk of Vasoplegic Syndrome: A Prospective Study.","Mic Mac Study: A Prospective Study of Hemodynamic Coherence in Vasoplegic Syndrome After Cardiopulmonary Bypass","MicMac","Inclusion Criteria:\n\nHave at least 3 point of the following risk factors for post-body circulation vasoplegic syndrome:\n\n* Acute or chronic heart failure with left ventricular ejection fraction\\\u003C 40% (1 pt)\n* Complex cardiac surgery ( 2 pts)\n* Cardiovascular risk factors with a EuroSCORE\\> 4% (1 pt)\n* Chronic Kidney Disease Stage 4\n* Type 2 Diabetes Mellitus\n* Pre-operative heparin treatment\n* Hypothyroidism\n* Anti-hypertensive treatments including an ACE inhibitor, an angiotensin II receptor antagonist, a beta-blocker or Sacubitril\n\nExclusion Criteria:\n\n* Heart transplantation\n* Pre-operative hemodynamic instability\n* Pregnant women\n* Age \\\u003C18\n* Pre-existing sepsis\n* Extracorporeal circulation support\n* Heartmate\u002FImpella\u002FCarmat patient\n* Hypothalamo-hypophyseal pathologies\n* Adrenal insufficiency\n* Anuric patient\n* Guardianship\u002F curatorship\n* Lack of social security coverage\n* Opposition to clinical research by patients or their families",true,"ALL","18 Years",{"count":138,"type":139},50,"ESTIMATED","OBSERVATIONAL","This research focuses on understanding the vasoplegic syndrome after cardiac surgery under extracorporeal circulation and in the aftermath of your surgery in the ICU.\n\nThe 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.\n\nThe 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.",[143],"Vasoplegic Syndrome of Cardiac Surgery",[145,146,147],"vasoplegia syndrome","post cardiopulmonary bypass","cardiac surgery","2025-07-10",{"date":150,"type":151},"2025-07-11","ACTUAL",{"date":153,"type":151},"2025-02-10",{"date":155,"type":139},"2026-12-31",{"name":5,"class":6},1]