[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiac-surgical-procedures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiac-surgical-procedures":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,54,93,123,148],{"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":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100640008","phase-4-rhbnp-for-prevention-of-cardiac-surgery-associated-acute-kidney-injury-csa-aki-100640008",false,"NCT07617675","rhBNP for Prevention of Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI)","Perioperative Recombinant Human Brain Natriuretic Peptide for Renal Protection in Cardiac Surgery: the PROTECT-CS Randomized Clinical Trial","PROTECT-CS","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled (elective) cardiac surgery requiring cardiopulmonary bypass\n* Presence of at least one of the following AKI risk factors:\n* Age ≥ 70 years\n* Preoperative renal impairment (eGFR ≤ 60 mL\u002Fmin\u002F1.73 m² or urine protein ≥ +2 at screening)\n* Type 2 diabetes mellitus\n* Heart failure, defined as NYHA Class II-IV with NT-proBNP ≥ 125 pg\u002FmL at screening; for participants with atrial fibrillation, NT-proBNP ≥ 365 pg\u002FmL is required\n* Able to understand and provide written informed consent, and willing and able to comply with all study protocol requirements\n\nExclusion Criteria:\n\n* Cardiogenic shock\n* Severe hypotension (systolic blood pressure ≤ 90 mmHg) at screening\n* Restrictive or obstructive cardiomyopathy, pericarditis, or cardiac tamponade\n* Preoperative chronic kidney disease stage 4 or higher (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²), or renal instability as judged by the investigator\n* Known AKI diagnosed per KDIGO criteria within 48 hours prior to surgery\n* Receipt of any form of renal replacement therapy within 30 days prior to surgery\n* Use of ventricular assist device, intra-aortic balloon pump, or any other mechanical cardiac support device within 7 days prior to surgery\n* Chronic hepatic insufficiency (Child-Pugh Class B or C) or hepatic dysfunction (ALT or AST \\> 2× upper limit of normal \\[ULN\\], or total bilirubin \\> 1.5× ULN)\n* Active hepatitis B (HBsAg positive with HBV-DNA indicating active viral replication), active hepatitis C (HCV antibody positive with HCV-RNA indicating active viral replication), positive syphilis screen, known HIV infection, or positive HIV test\n* Confirmed or treated endocarditis, sepsis, or active infection requiring antibiotic treatment within 30 days prior to surgery\n* Requirement for aortic dissection repair, complex congenital heart surgery, emergency surgery, or life-saving surgery\n* History of malignant tumor, solid tumor, metastatic tumor, or hematological malignancy within the past 5 years\n* Prior organ transplantation or current use of immunosuppressive agents\n* Any condition that may conflict with or contraindicate the use of intravenous vasodilator therapy\n* Prior adverse reaction to nesiritide (recombinant BNP)\n* Participation in any other clinical trial within 30 days prior to surgery\n* Pregnant or breastfeeding women\n* Any other condition that, in the judgment of the investigator, renders the participant unsuitable for study participation","ALL","18 Years",{"count":20,"type":21},694,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Cardiac surgery-associated acute kidney injury (CSA-AKI) is a common and serious perioperative complication, independently associated with prolonged hospitalization, increased mortality, and progression to chronic kidney disease. Despite advances in surgical techniques and postoperative care, no widely accepted pharmacological prevention strategy exists.\n\nRecombinant human brain natriuretic peptide (rhBNP) exerts vasodilatory, diuretic, and natriuretic effects, reduces cardiac preload and afterload, and has demonstrated safety and efficacy in treating congestive heart failure. Preliminary studies suggest rhBNP may reduce postoperative serum creatinine, increase urine output, and improve renal outcomes; however, large-scale randomized controlled evidence is lacking.\n\nThe PROTECT-CS trial is a multicenter, prospective, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of perioperative continuous intravenous rhBNP infusion (0.01 μg\u002Fkg\u002Fmin for 48 ± 2 hours) for prevention of AKI in high-risk patients undergoing cardiac surgery with cardiopulmonary bypass. A total of 694 participants will be enrolled across 7 centers in China.",[27,28,29],"AKI - Acute Kidney Injury","Cardiac Surgical Procedures","Cardiopulmonary Bypass",[31,32,33,34,35,36,37,38,39,40],"Recombinant human brain natriuretic peptide","rhBNP","Nesiritide","Acute kidney injury","Cardiac surgery","Cardiopulmonary bypass","Renal protection","Randomized controlled trial","Cardiac surgery-associated acute kidney injury","CSA-AKI","NOT_YET_RECRUITING","2026-05-29",{"date":44,"type":45},"2026-06-01","ACTUAL",{"date":47,"type":21},"2026-05-01",{"date":49,"type":21},"2029-07-31",{"name":51,"class":52},"China National Center for Cardiovascular Diseases","OTHER_GOV",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":73,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":53},"100633038","llm-based-intelligent-health-management-assistant-in-life-cycle-health-management-of-cardiac-surgery-patients-100633038","NCT07521488","LLM-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Cardiac Surgery Patients","Application of Large Language Model-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Patients After Cardiac Surgery: A Prospective Randomized Controlled Study","cFT-LLM","Inclusion Criteria:\n\n1. Aged 18 years or older, any sex\n2. Underwent cardiac surgery at the Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, including but not limited to: coronary artery bypass grafting (CABG), heart valve replacement or repair (aortic valve, mitral valve, or tricuspid valve surgery), great vessel surgery (aortic dissection or aortic aneurysm repair), congenital heart disease correction, or cardiac assist device implantation\n3. Clinically stable after surgery and eligible for hospital discharge\n4. Has access to a smartphone and is capable of independently operating a mobile application, or has a family member available to assist with operation\n5. Voluntarily participates in the study, understands and signs the informed consent form, and is able to comply with the study protocol requirements\n\nExclusion Criteria:\n\n1. Postoperative intensive care unit (ICU) stay exceeding 30 days, or presence of severe uncontrolled postoperative complications such as persistent infection or multi-organ failure\n2. Life expectancy less than 12 months due to advanced malignancy or end-stage organ failure\n3. Severe cognitive impairment, psychiatric disorder, or inability to understand and use a mobile application without available caregiver assistance\n4. Heart transplant recipient\n5. Currently participating in another interventional clinical study\n6. Anticipated inability to complete 12-month follow-up",{"count":63,"type":21},500,[65],"NA","This is a single-center, prospective, randomized, open-label, parallel-controlled clinical study to evaluate the effectiveness of a large language model (LLM)-based intelligent health management assistant in the life-cycle health management of patients after cardiac surgery. A total of 500 adult patients who undergo cardiac surgery (including coronary artery bypass grafting, heart valve surgery, great vessel surgery, congenital heart disease correction, and other cardiac procedures) at Beijing Anzhen Hospital will be randomly assigned in a 1:1 ratio to an intervention group or a control group, stratified by age (\\\u003C65 vs ≥65 years) and surgery type. The intervention group will use the LLM-based mobile health management application in addition to standard postoperative care, while the control group will receive standard postoperative care alone. The application integrates multimodal clinical data into a personalized health profile and provides surgery-type-specific postoperative management recommendations, medication adherence reminders, complication early warning, and cardiac rehabilitation guidance. The primary outcome is the composite endpoint of major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke, or unplanned cardiovascular reoperation\u002Freintervention, within 12 months after randomization. Secondary outcomes include health-related quality of life (EQ-5D-5L), cardiovascular rehospitalization rate, medication adherence (MMAS-8), postoperative complication rate, and cardiac rehabilitation achievement rate. Follow-up visits are scheduled at 1, 3, 6, 9, and 12 months post-randomization.",[68,69,70,71,72,28],"Coronary Artery Bypass Grafting","Heart Valve Disease","Aortic Aneurysm","Aortic Dissection","Congenital Heart Disease",[74,75,76,77,78,79,80,81,82,83],"Large Language Model","Artificial Intelligence","Cardiac Surgery","Postoperative Health Management","Digital Health","Medication Adherence","Cardiac Rehabilitation","MACCE","Mobile Health Application","Personalized Health Management","2026-04-08",{"date":86,"type":45},"2026-04-13",{"date":47,"type":21},{"date":89,"type":21},"2027-12-31",{"name":91,"class":92},"Beijing Anzhen Hospital","OTHER",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":110,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":53},"100629597","effect-of-transcutaneous-auricular-vagus-nerve-stimulation-on-postoperative-delirium-and-negative-emotions-in-patients-undergoing-cardiac-surgery-100629597","NCT07476742","Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium and Negative Emotions in Patients Undergoing Cardiac Surgery","Effect of Intraoperative Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Delirium and Negative Emotional States in Patients Undergoing Cardiac Surgery: A Multicenter, Randomized, Double-Blind, Sham-Controlled Trial","Inclusion Criteria:\n\n* Aged 18 to 85 years. Scheduled for elective cardiac surgery (e.g., CABG, valve replacement\u002Frepair). NYHA cardiac function class I-III. Willing and able to provide informed consent. Expected surgery duration ≥ 2 hours.\n\nExclusion Criteria:\n\n* Preoperative MMSE score \\\u003C 24; severe communication barriers. History of diagnosed delirium, dementia, Parkinson's disease, schizophrenia, bipolar disorder, major depressive disorder, or long-term use of psychotropic drugs.\n\nSkin lesions, infection, or deformity of bilateral ears; history of ear surgery or nerve injury; allergy to electrode materials.\n\nSevere arrhythmia; implanted electronic devices (e.g., pacemaker, ICD). Participation in another interventional trial within 3 months. Other conditions deemed unsuitable by investigators.","85 Years",{"count":102,"type":21},270,[65],"A multicenter, randomized, double-blind, sham-controlled trial to investigate the effects of intraoperative transcutaneous auricular vagus nerve stimulation (taVNS) on the incidence of postoperative delirium and negative emotional states (anxiety, depression) in patients undergoing elective cardiac surgery.",[106,107,108,109,28],"Postoperative Delirium (POD)","Postoperative","Anxiety","Depression",[111,76,112,109,108,113],"Transcutaneous Vagus Nerve Stimulation","Postoperative Delirium","Randomized Controlled Trial","2026-03-12",{"date":116,"type":45},"2026-03-17",{"date":118,"type":21},"2026-02-28",{"date":120,"type":21},"2027-02-28",{"name":122,"class":92},"Chinese PLA General Hospital",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":144,"leadSponsor":146,"locationsCount":53},"100619737","diuretic-effect-of-aminophylline-and-furosemide-in-adult-patients-undergoing-cardiac-surgical-procedures-100619737","NCT07348510","Diuretic Effect of Aminophylline and Furosemide in Adult Patients Undergoing Cardiac Surgical Procedures","Comparison Between the Diuretic Effect of Aminophylline and Furosemide in Adult Patients Undergoing Cardiac Surgical Procedures: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age from 18-65 years.\n* Both sexes.\n* All adult patients presenting for elective cardiac surgical procedures performed on cardiopulmonary bypass (Coronary artery bypass surgery, Cardiac valve repair and\u002For replacement, Repair of large septal defects, Repair and\u002For palliation of congenital heart defects, Transplantation, surgery of thoracic aneurysms.).\n* Body mass index (BMI) ranged between 20 and 40 kg\u002Fm2.\n\nExclusion Criteria:\n\n* Sensitivity or contraindication to Aminophylline or furosemide\n* Stage-5 chronic kidney disease (CKD) \\[Glomerular filtration rate (GFR) of less than 15 mL\u002Fmin\\].\n* The presence of both factors (GFR less than 60 mL\u002Fmin and albumin greater than 30 mg per gram of creatinine) along with abnormalities of kidney structure or function for greater than three months signifies chronic kidney disease.\n* Recipients of dialysis before surgery.\n* Recipients of solid-organ transplantation before surgery.\n* Emergency cardiac surgical procedures (e.g. left main coronary artery bypass graft, stuck valves, etc).\n* Patient refusal.","65 Years",{"count":132,"type":21},106,[65],"This work aims to investigate the diuretic effect of Aminophylline in comparison to Furosemide in adult patients undergoing cardiac surgical procedures.",[136,137,138,28],"Diuretic Effect","Aminophylline","Furosemide","RECRUITING","2026-01-17",{"date":142,"type":45},"2026-01-21",{"date":140,"type":45},{"date":145,"type":21},"2026-07-26",{"name":147,"class":92},"Cairo University",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":167,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"100589322","femoral-versus-radial-invasive-arterial-pressure-monitoring-in-cardiac-surgery-patients-100589322","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",{"count":157,"type":21},340,[65],"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.",[161,162,28,163,164,165,166],"Vasoplegia Syndrome","Vasoplegia","Arterial Pressure","Hypotension During Surgery","Hypotension Postprocedural","Norepinephrine",[168,169,35,166],"Invasive arterial blood pressure monitoring","Vasoplegia syndrome","2025-12-16",{"date":172,"type":45},"2025-12-22",{"date":174,"type":45},"2025-06-15",{"date":176,"type":21},"2027-08-01",{"name":178,"class":92},"Guillaume BESCH",2]