[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"norepinephrine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:norepinephrine":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,80,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100589322","femoral-versus-radial-invasive-arterial-pressure-monitoring-in-cardiac-surgery-patients-100589322",false,"NCT06952907","Femoral Versus Radial Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients","Femoral Versus Radial Artery Catheterization for Invasive Arterial Pressure Monitoring in Cardiac Surgery Patients: the FERARI Randomized Superiority Study","FERARI","Inclusion Criteria:\n\n* Male and female patients ≥18 years\n* Scheduled cardiac surgery with cardiopulmonary bypass (time between anesthesia consultation and surgery \\> 48 hours)\n* ASA physical status ≥II\n* Affiliation with or beneficiary of the French national health insurance system\n* Signed informed consent indicating that the participant has understood the purpose and procedures of the study and agrees to participate and comply with its requirements and restrictions\n\nExclusion Criteria:\n\n* Emergency surgery (before the next working day after decision to operate)\n* Surgery requiring the use of two arterial pressure monitoring sites: e.g., aortic arch surgery, aortic dissection, etc.\n* Heart transplantation surgery\n* Mechanical circulatory support\n* Contraindication to radial artery catheterization: failed Allen test, Raynaud syndrome, Buerger disease, major hyperlipidemia\n* Contraindication to femoral artery catheterization: puncture of vascular prosthetic material in the femoral area (e.g., femoral bypass, femoral stenting, femoral trifurcation endarterectomy, femoral angioplasty)\n* Pregnant or breastfeeding women\n* Persons deprived of liberty by judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a healthcare or social institution for reasons other than research\n* Adults under legal protection measures (guardianship, trusteeship, or legal safeguard) or unable to give informed consent\n* Subjects currently under exclusion period of another clinical trial or listed in the national registry of research volunteers","ALL","18 Years",{"count":20,"type":21},340,"ESTIMATED","INTERVENTIONAL",[24],"NA","Background: Acute circulatory failure, often presenting as arterial hypotension, is a major contributor to postoperative morbidity and mortality. Accurate blood pressure (BP) monitoring is essential for timely therapeutic intervention, particularly in patients undergoing major surgery. Among invasive BP measurement sites, the radial artery is commonly used due to its accessibility and ease of catheterization. However, physiologically, the radial artery may underestimate central arterial pressure compared to the femoral artery, especially in patients receiving vasopressors or in critical conditions. This discrepancy can lead to overtreatment with vasopressors and associated complications. Current literature on the accuracy of radial versus femoral BP monitoring is outdated and based solely on observational studies. There is a lack of high-quality randomized data to inform clinical guidelines.\n\nHypothesis: Femoral arterial pressure monitoring, by offering more accurate hemodynamic data, reduces the need for vasopressor support, particularly norepinephrine, compared to radial artery monitoring.\n\nPrimary Objective: To compare the effect of femoral versus radial invasive BP monitoring on the proportion of patients requiring norepinephrine from anesthetic induction to postoperative day 7 (D7) following elective cardiac surgery. Norepinephrine treatment is defined by continuous intravenous administration of norepinephrine for more than 1 minute.\n\nSecondary Objectives :\n\nTo compare the following outcomes between the two strategies within the first 7 postoperative days: incidence of acute kidney injury (AKI) according to KDIGO criteria, incidence of cardiac complications (arrhythmias requiring treatment, myocardial injury (troponin \\>99th percentile or \\>20% rise from baseline), myocardial infarction, cardiogenic shock, cardiac arrest), vaso-inotropic score (VIS), duration of any vasopressor therapy (days), ICU and hospital length of stay (days), all-cause mortality at day 7 and day 30, total duration (hours\u002Fdays) and maximal dose of norepineprhine therapy, intraoperative hypotension episodes (MAP\\\u003C65 mmHg \\> 5 min), incidence of arterial catheter-related complications (hematoma, bleeding, infection, thrombosis, arterial occlusion, malfunction, dislodgement).\n\nPrimary Endpoint: The proportion of patients receiving continuous intravenous norepinephrine from anesthesia induction to postoperative day 7.\n\nSecondary Endpoints:\n\nAKI occurrence or need for renal replacement therapy; cardiac complications: atrial\u002Fventricular arrhythmias requirinf treatment, myocardial injury (troponin \\>99th percentile or \\>20% rise from baseline), myocardial infarction (biomarker elevation + ECG or echocardiographic abnormalities), cardiogenic shock, cardiac arrest; maximum VIS in the OR, ICU admission, and day 1; intraoperative hypotension episodes (MAP\\\u003C65 mmHg \\> 5 min); total norepinephrine support duration (in hours); duration of any vasopressor therapy; arterial line complications: malfunction, dislodgement, hematoma, thrombosis, infection, bleeding, arterial occlusion; ICU and hospital length of stay (days); all-cause mortality at day 7 and day 30\n\nStudy Design: A prospective, multicenter (Besançon and Dijon University Hospitals), randomized, superiority, single-blind, intention-to-treat clinical trial in adults undergoing elective cardiac surgery. Patients are randomized to femoral or radial artery catheterization for continuous BP monitoring.\n\nSample Size: Based on an expected norepinephrine use rate of 70%, a 15% absolute risk reduction, α = 0.05, and power = 90%, 162 patients per group are required. Accounting for 5% data loss, 340 patients will be enrolled.\n\nStudy Arms:\n\nRadial group: invasive BP monitoring via radial artery catheterization Femoral group: invasive BP monitoring via femoral artery catheterization The arterial line is placed under ultrasound guidance in the operating room and maintained postoperatively in the ICU or critical care unit until no longer clinically indicated.\n\nEligibility Criteria Inclusion: adults patients ≥18 years undergoing elective on-pump cardiac surgery with informed consent.\n\nExclusion: emergency surgery, use of dual arterial lines, heart transplantation, mechanical circulatory support, contraindications to radial\u002Ffemoral catheterization, legal or ethical inability to consent.\n\nStudy Timeline Inclusion period: 36 months Patient follow-up: 7 days post-surgery Total study duration: 36 months\n\nData Collection: Clinical data are collected by research staff using an electronic case report form (e-CRF) via CleanWeb™ software.\n\nExpected Impact: There are currently no guidelines specifying the optimal site for invasive BP monitoring. This study aims to provide robust evidence on whether femoral BP monitoring improves clinical outcomes, reduces vasopressor use, and minimizes adverse events. Positive findings could inform future practice guidelines and lead to broader investigations in other clinical settings.",[27,28,29,30,31,32,33],"Vasoplegia Syndrome","Vasoplegia","Cardiac Surgical Procedures","Arterial Pressure","Hypotension During Surgery","Hypotension Postprocedural","Norepinephrine",[35,36,37,33],"Invasive arterial blood pressure monitoring","Vasoplegia syndrome","Cardiac surgery","RECRUITING","2025-12-16",{"date":41,"type":42},"2025-12-22","ACTUAL",{"date":44,"type":42},"2025-06-15",{"date":46,"type":21},"2027-08-01",{"name":48,"class":49},"Guillaume BESCH","OTHER",2,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100523951","the-effect-of-two-different-doses-of-noradrenaline-on-hypotension-caused-by-spinal-anesthesia-for-cesarean-section-100523951","NCT06102382","The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section","Inclusion Criteria:\n\n* Pregnant women scheduled for cesarean section under spinal anesthesia\n* Gestational age of at least 37 weeks\n\nExclusion Criteria:\n\n* Patient refusal\n* Contraindications of spinal anesthesia\n* Allergy to the study drug\n* Height\\\u003C150 cm, weight \\\u003C 60 kg, body mass index (BMI) ≥40 kg\u002Fm2.\n* patients with cardiac morbidities\n* Hypertensive disorders of pregnancy.\n* Prepartum hemorrhage","FEMALE","19 Years","40 Years",{"count":61,"type":21},100,[24],"To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.",[65,66,33],"Cesarean Section","Hypotension",[33,68,66,69],"Spinal anesthesia","Cesarean section","2025-08-24",{"date":72,"type":42},"2025-08-29",{"date":74,"type":42},"2024-09-01",{"date":76,"type":21},"2025-12-01",{"name":78,"class":49},"Assiut University",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100580968","postoperative-delirium-after-intraoperative-ephedrine-versus-norepinephrine-100580968","NCT06844201","Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine","Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine: a Retrospective TriNetX Database Study","Ephedrine group:\n\nInclusion Criteria:\n\n* underwent surgery (CPT code 1003143)\n* administered ephedrine on the day of surgery\n\nExclusion Criteria:\n\n* received both vasopressors (ephedrine and norepinephrine) on the day of surgery.\n* patients who underwent neurology and neuromuscular surgery, cardiac surgery, and cardiac procedures\n* patients who were administered epinephrine or dopamine on the day of surgery\n* patients who were administered ephedrine or norepinephrine at any time within the 7 days following the day of surgery\n* a prior history of disorientation (ICD-10 code R41.0) or unspecified dementia (F03)\n\nNorepinephrine group:\n\nInclusion Criteria:\n\n* underwent surgery (CPT code 1003143)\n* administered norepinephrine on the day of surgery\n\nExclusion Criteria:\n\n* received both vasopressors (ephedrine and norepinephrine) on the day of surgery.\n* patients who underwent neurology and neuromuscular surgery, cardiac surgery, and cardiac procedures\n* patients who were administered epinephrine or dopamine on the day of surgery\n* patients who were administered ephedrine or norepinephrine at any time within the 7 days following the day of surgery\n* a prior history of disorientation (ICD-10 code R41.0) or unspecified dementia (F03)",{"count":88,"type":21},10000,"OBSERVATIONAL","This retrospective study aims to investigate the effects of norepinephrine compared to ephedrine, administered on the day of surgery, on the incidence of postoperative delirium.",[92,33,93],"Ephedrine","Postoperative Delirium (POD)",[92,33,95],"Postoperative delirium","NOT_YET_RECRUITING","2025-02-19",{"date":99,"type":42},"2025-02-25",{"date":101,"type":21},"2025-02-20",{"date":103,"type":21},"2025-08-01",{"name":105,"class":49},"Riverside University Health System Medical Center",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":79},"100510172","norepinephrine-weaning-guided-by-the-hypotension-prediction-index-in-vasoplegic-shock-after-cardiac-surgery-100510172","NCT05922982","Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery","NORAHPI","Inclusion Criteria:\n\n* Age \\> 18 years\n* The patient was hospitalized in the cardiothoracic-vascular and respiratory intensive care unit of Amiens-Picardy University Hospital.\n* Patient scheduled for on-pomp cardiac surgery \\[coronary artery bypass grafting, valve replacement, ascending aorta replacement, or combined surgery (valve and bypass grafting)\\].\n* Introduction of norepinephrine post-surgery for the treatment of vasoplegic syndrome.\n* On-pomp cardiac surgery in less than 48 hours.\n* Hemodynamically stable patient with MAP \\> 65 mmHg for more than 4 hours on noradrenaline\n* Monitoring of MAP with a radial or femoral arterial catheter\n* Social security beneficiary\n* Signature of the consent to participate in the study by the patient, preoperatively\n\nExclusion Criteria:\n\n* Permanent arrhythmia (atrial fibrillation, flutter, or frequent atrial extrasystoles).\n* Treatment with dobutamine, epinephrine, or vasopressin analog\n* Patients with preoperative chronic end-stage renal failure require postoperative extra-renal purification.\n* Pregnant woman\n* The patient is dependent on an internal or external pacemaker.\n* Hypothermia \\\u003C 36°.\n* Patient under mechanical circulatory assistance after cardiac surgery.\n* Hemorrhagic shock\n* Patient under guardianship or curators",{"count":114,"type":21},142,[24],"In postoperative cardiac surgery under extracorporeal circulation, the patient may develop a vasoplegic syndrome, characterized by arterial hypotension (mean arterial pressure (MAP) \\\u003C 65 mmHg); a decrease in vascular resistance and a cardiac output that may be normal or increased, and increased postoperative mortality\u002F International recommendations recommend the prescription of noradrenaline as a first-line treatment to reduce morbidity and mortality. However, excess norepinephrine or duration of exposure is also deleterious. The Acumen IQ device (Edwards Lifesciences) allows the calculation of a predictive index of arterial hypotension episodes (predictive hypotension index, HPI). HPI could improve norepinephrine weaning by preventing episodes of arterial hypotension or detecting preload dependence, thus avoiding the transient increase in norepinephrine during hypotension.\n\nThis is a single-center, prospective, open-label, randomized, controlled, 2-group, parallel, intention-to-treat study. The aim was to evaluate the superiority of a new decision algorithm, based on the HPI delivered by the Acumen IQ device, to reduce the duration of norepinephrine administration in post-cardiac surgery vasoplegic shock.\n\nThe duration of the interventional protocol is 72 hours. To evaluate the clinical impact of the protocol, the time of the study will be 30 days. Several follow-up visits will be performed (end-of-protocol day, discharge day, and at D30 of inclusion) to collect clinical, biological, and HPI monitoring data.",[28,118,33,119],"Shock","Surgery",[121,122,123,124,125,126,127],"vasoplegia","shock","hypotension prediction index","Acumen","CABG","norepinephrine","surgery","2024-07-02",{"date":130,"type":42},"2024-07-03",{"date":132,"type":42},"2023-09-01",{"date":134,"type":21},"2025-07",{"name":136,"class":49},"Centre Hospitalier Universitaire, Amiens"]