[{"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,8,0,[8,51,81,114,151,188,217,242],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"100651477","erector-spinae-oxygen-saturation-and-aki-after-opcab-100651477",false,"NCT07760129","Erector Spinae Oxygen Saturation and AKI After OPCAB","Erector Spinae Muscle Oxygen Saturation as an Early Predictor of Acute Kidney Injury in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery","Inclusion Criteria:\n\n1. Adults aged 19 years or older scheduled for elective off-pump coronary artery bypass (OPCAB) surgery.\n2. Able to receive a full explanation of the purpose and procedures of the study and to provide written informed consent voluntarily.\n3. Depth from the skin to the erector spinae muscle at the level of the left renal hilum, measured by ultrasonography in the operating room before anesthetic induction, of less than 2.0 cm, so that stable near-infrared spectroscopy measurement is considered feasible. Consenting patients who do not meet this criterion are not enrolled and are classified as screen failures.\n\nExclusion Criteria:\n\n1. Emergency surgery.\n2. Concomitant surgery performed by another department.\n3. Preoperative or postoperative cardiogenic shock, or need for mechanical circulatory support.\n4. Estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m2.\n5. Previous kidney transplantation.\n6. Left renal disease or a solitary kidney.\n7. Body mass index above 30 kg\u002Fm2.\n8. Active bleeding or active infection.\n9. Inability to read and voluntarily consent to the informed consent document (for example, because of illiteracy, language barrier, or cognitive impairment).\n10. Refusal to participate in the study.","ALL","19 Years",{"count":19,"type":20},138,"ESTIMATED","OBSERVATIONAL","Acute kidney injury (AKI) is a frequent and serious complication after cardiac surgery, including off-pump coronary artery bypass (OPCAB). Because AKI is diagnosed on the basis of serum creatinine, which rises 1 to 2 days after the actual renal insult, early detection and timely intervention remain difficult. Near-infrared spectroscopy (NIRS) allows non-invasive and continuous measurement of regional tissue oxygen saturation, but the effective penetration depth of commercially available devices is only approximately 2 to 2.5 cm. In most adults the renal cortex lies deeper than this, so the signal obtained from a flank sensor may originate largely from the abdominal wall musculature rather than from renal parenchyma. This limitation may explain the inconsistent association between renal regional oxygen saturation (renal rSO2) and AKI reported so far.\n\nThe erector spinae muscle at the level of the renal hilum lies within 2 cm of the skin in most patients and is supplied by the lumbar arteries and by vessels adjacent to the renal hilum. Erector spinae muscle regional oxygen saturation (ESrSO2) may therefore provide a technically more reliable NIRS signal that reflects perfusion of a vascular territory close to that of the kidney, particularly during the transient low cardiac output state induced by mechanical displacement of the heart for coronary anastomosis during OPCAB.\n\nThis single-center prospective observational cohort study will enroll 138 adult patients scheduled for elective OPCAB at Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea. ESrSO2 and renal rSO2 will be measured continuously with an INVOS oximeter from before anesthetic induction until the end of surgery, in addition to cerebral rSO2, which is part of standard care at the participating institution. The ESrSO2 and renal rSO2 channels will be physically masked on the monitor display during surgery, no alarms will be set for these two channels, and their values will not be used for any intraoperative clinical decision. The recorded data will be extracted after surgery using the INVOS Analytics Tool. Apart from placement of the additional NIRS sensors and a brief pre-induction ultrasound measurement of tissue depth, no study-specific procedure, laboratory test, or imaging study will be performed, and all anesthetic, surgical, and postoperative care will follow the standard institutional protocol.\n\nThe primary objective is to identify which ESrSO2-derived variable best predicts postoperative AKI, defined by the Kidney Disease: Improving Global Outcomes (KDIGO) criteria within 7 days after surgery. The candidate variables are the baseline value, the intraoperative nadir, the area under the threshold (AUT), and the duration under the threshold below absolute values of 60%, 55%, and 50% and below 80% of the baseline value, calculated separately for the period before cardiac displacement and for the cardiac displacement period. Secondary objectives are to assess whether the selected ESrSO2 variable provides independent and incremental predictive information beyond a pre-specified baseline risk model, to compare the predictive performance of ESrSO2 with that of cerebral rSO2 and renal rSO2, and to evaluate the prediction of severe AKI (KDIGO stage 2 to 3) and persistent AKI (lasting 48 hours or longer).\n\nIf ESrSO2 proves to be a useful early marker of AKI, it could allow real-time, non-invasive identification of patients at high risk during surgery and provide a basis for future trials of renal protective strategies.",[24,25,26,27,28,29],"Acute Kidney Injury","Coronary Artery Disease","Coronary Artery Bypass, Off-Pump","Postoperative Complications","Cardiac Surgical Procedures","Spectroscopy, Near-Infrared",[31,32,33,34,35,36,37,38],"rector spinae muscle regional oxygen saturation (ESrSO2)","near-infrared spectroscopy (NIRS)","regional oxygen saturation (rSO2","off-pump coronary artery bypass (OPCAB)","acute kidney injury (AKI)","KDIGO","area under the threshold (AUT)","tissue oximetry","NOT_YET_RECRUITING","2026-08-06",{"date":42,"type":43},"2026-08-12","ACTUAL",{"date":45,"type":20},"2026-10-01",{"date":47,"type":20},"2029-12-31",{"name":49,"class":50},"Yonsei University","OTHER",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100649702","phase-2-terbinafine-for-csa-aki-prevention-100649702","NCT07738328","Terbinafine for CSA-AKI Prevention","Terbinafine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged ≥18 and ≤75 years, without restriction on gender.\n* Patients with a definite clinical diagnosis scheduled for elective cardiac and macrovascular surgery with cardiopulmonary bypass (CPB) support, including but not limited to coronary artery bypass grafting (CABG), cardiac valve replacement\u002Frepair, structural heart disease surgery, aortic arch plasty, or combined procedures of the above surgeries.\n* Classified as high risk by AKI risk scoring system, with a total score ≥4 points.\n* The subject or their legal representative shall fully understand the purpose, procedures, potential risks and benefits of this study, and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* Patients with severe chronic renal insufficiency (eGFR \\\u003C 50 mL\u002Fmin\u002F1.73 m² or serum creatinine \\> 300 μmol\u002FL), or those receiving any form of renal replacement therapy (e.g., hemodialysis, peritoneal dialysis).\n* Pre-existing acute kidney injury.\n* Presence of chronic or active liver diseases, including decompensated liver cirrhosis, active viral hepatitis, autoimmune liver disease, etc.; or preoperative laboratory tests showing ALT\u002FAST ≥ 2 times the upper limit of normal (ULN).\n* Severe hematological diseases (preoperative white blood cell count \\\u003C 3.0 × 10⁹\u002FL, platelet count \\\u003C 80 × 10⁹\u002FL).\n* Uncontrolled active infections, or known immunodeficiency disorders (e.g., HIV infection, status post organ transplantation).\n* History of severe hypersensitivity to terbinafine or any excipients of its formulation.\n* Pregnant or lactating women, as well as women of childbearing potential who plan to conceive during the study and refuse to use effective contraception.\n* Participation in any other clinical trial of investigational drugs or medical devices within 3 months prior to screening.\n* Patients deemed inappropriate for enrollment in this study at the investigator's clinical discretion.","18 Years","75 Years",{"count":61,"type":20},208,"INTERVENTIONAL",[64],"PHASE2","Primary Objective: To evaluate the efficacy and safety of perioperative oral terbinafine in reducing the incidence of cardiac surgery-associated acute kidney injury (CSA-AKI).Secondary Objectives:To assess the effects of terbinafine on the severity of post-cardiac surgery AKI, length of hospital stay, and 30-day major adverse kidney events (MAKE30);To evaluate its impacts on biomarkers of renal injury and inflammation.",[24,28],[24,68,69,70],"Cardiac Surgery-Associated Acute Kidney Injury","Terbinafine","Randomized","2026-07-27",{"date":73,"type":43},"2026-07-31",{"date":75,"type":20},"2026-09-01",{"date":77,"type":20},"2028-05-01",{"name":79,"class":50},"Guangdong Provincial People's Hospital",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":93,"studyType":21,"phases":4,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":110,"leadSponsor":112,"locationsCount":80},"100646455","dynamic-multimodal-delirium-warning-after-cardiac-surgery-100646455","NCT07686900","Dynamic Multimodal Delirium Warning After Cardiac Surgery","A Dynamic Early Warning System for Postoperative Delirium After Cardiac Surgery Integrating EEG, Cerebral Oxygenation, Hemodynamic Physiology, and Clinical Risk Factors","DEW-POD","Inclusion Criteria:\n\n1. Adult patients (18-80 years) admitted to the Department of Critical Care Medicine.\n2. Underwent cardiac surgery.\n3. Under multimodal monitoring (including EEG, cerebral oximetry, and invasive arterial blood pressure).\n4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Pre-existing dementia, history of psychiatric disorders, or long-term use of antipsychotic medications, preventing accurate assessment of delirium.\n2. Preoperative severe hepatic or renal insufficiency (Child-Pugh Class C or eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n3. Severe craniocerebral injury, intracranial space-occupying lesion, or history of epilepsy.\n4. Inability to obtain continuous EEG or cerebral oximetry signals due to technical reasons (e.g., scalp injury, abnormal probe placement site).\n5. Patients expected to die within 24 hours.\n6. Patients deemed unsuitable for the study by the investigator.","15 Years","80 Years",{"count":92,"type":20},200,"28 Days","After heart surgery, up to half of all patients may develop a state of sudden confusion called postoperative delirium. This condition can lead to longer time on a breathing machine, extended stays in the intensive care unit (ICU), and a slower overall recovery. Currently, doctors have no reliable way to predict delirium early enough to take preventive action. This study aims to build a computer-based early warning system. The system will combine continuous, real-time measurements of brain waves (EEG), the oxygen level in the brain, and heart and blood pressure function. It will also include information about each patient's health status. By analyzing all of these signals together, the model is designed to give an alert 1 to 6 hours before delirium might start, giving the care team a window of time to intervene. The study will take place in the ICU at Zhongda Hospital, Southeast University. Adults between 18 and 80 years old who are admitted to the ICU after heart surgery will be invited to participate. All patients will receive the usual standard of care; the study does not test any new treatment. Participation means the investigators will continuously record the brain, oxygen, and heart signals that are already being monitored, and a researcher will regularly assess the patient's thinking and alertness with a simple bedside check.",[96,28],"Postoperative Delirium",[96,98,99,100,101,102,103,104,105],"Cardiac Surgery","Electroencephalography","EEG","Cerebral Oximetry","Near-Infrared Spectroscopy","Hemodynamics","Multimodal Monitoring","Early Warning System","2026-07-06",{"date":108,"type":43},"2026-07-08",{"date":106,"type":20},{"date":111,"type":20},"2027-12-30",{"name":113,"class":50},"Southeast University, China",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":62,"phases":124,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":80},"100640008","phase-4-rhbnp-for-prevention-of-cardiac-surgery-associated-acute-kidney-injury-csa-aki-100640008","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",{"count":123,"type":20},694,[125],"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.",[128,28,129],"AKI - Acute Kidney Injury","Cardiopulmonary Bypass",[131,132,133,134,135,136,137,138,139,140],"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","2026-05-29",{"date":143,"type":43},"2026-06-01",{"date":145,"type":20},"2026-05-01",{"date":147,"type":20},"2029-07-31",{"name":149,"class":150},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":62,"phases":161,"briefSummary":163,"conditions":164,"keywords":170,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":184,"leadSponsor":186,"locationsCount":80},"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":160,"type":20},500,[162],"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.",[165,166,167,168,169,28],"Coronary Artery Bypass Grafting","Heart Valve Disease","Aortic Aneurysm","Aortic Dissection","Congenital Heart Disease",[171,172,98,173,174,175,176,177,178,179],"Large Language Model","Artificial Intelligence","Postoperative Health Management","Digital Health","Medication Adherence","Cardiac Rehabilitation","MACCE","Mobile Health Application","Personalized Health Management","2026-04-08",{"date":182,"type":43},"2026-04-13",{"date":145,"type":20},{"date":185,"type":20},"2027-12-31",{"name":187,"class":50},"Beijing Anzhen Hospital",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":62,"phases":198,"briefSummary":199,"conditions":200,"keywords":205,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":80},"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":197,"type":20},270,[162],"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.",[201,202,203,204,28],"Postoperative Delirium (POD)","Postoperative","Anxiety","Depression",[206,98,96,204,203,207],"Transcutaneous Vagus Nerve Stimulation","Randomized Controlled Trial","2026-03-12",{"date":210,"type":43},"2026-03-17",{"date":212,"type":20},"2026-02-28",{"date":214,"type":20},"2027-02-28",{"name":216,"class":50},"Chinese PLA General Hospital",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":62,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":238,"leadSponsor":240,"locationsCount":80},"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":226,"type":20},106,[162],"This work aims to investigate the diuretic effect of Aminophylline in comparison to Furosemide in adult patients undergoing cardiac surgical procedures.",[230,231,232,28],"Diuretic Effect","Aminophylline","Furosemide","RECRUITING","2026-01-17",{"date":236,"type":43},"2026-01-21",{"date":234,"type":43},{"date":239,"type":20},"2026-07-26",{"name":241,"class":50},"Cairo University",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":62,"phases":252,"briefSummary":253,"conditions":254,"keywords":261,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":273},"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":251,"type":20},340,[162],"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.",[255,256,28,257,258,259,260],"Vasoplegia Syndrome","Vasoplegia","Arterial Pressure","Hypotension During Surgery","Hypotension Postprocedural","Norepinephrine",[262,263,135,260],"Invasive arterial blood pressure monitoring","Vasoplegia syndrome","2025-12-16",{"date":266,"type":43},"2025-12-22",{"date":268,"type":43},"2025-06-15",{"date":270,"type":20},"2027-08-01",{"name":272,"class":50},"Guillaume BESCH",2]