[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiac-surgery-associated---acute-kidney-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiac-surgery-associated---acute-kidney-injury":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,72,103,124,152,175,197],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100605616","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-bx-001n-in-preventing-cardiac-surgery-associated-acute-kidney-injury-csa-aki-and-major-adverse-kidney-events-make-100605616",false,"NCT07164833","A Study to Evaluate the Efficacy and Safety of BX-001N in Preventing Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Major Adverse Kidney Events (MAKE)","Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a Clinical Trial of BX-001N to Prevent From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE)","Inclusion Criteria:\n\n1. 19 to 90 years of age\n2. Participants with aortic disease scheduled for cardiac surgery via total circulatory arrest (TCA)\n3. Body weight ≥ 30 kg\n4. Participants with vital signs within the following ranges\n\n   * Temperature : 35.0\\~37.5°C\n   * Blood pressure : Systolic blood pressure(SBP) 100\\~160 mmHg, Diastolic blood pressure(DBP) \\\u003C 100 mmHg\n   * Pulse : 50\\~100 bpm (regardless of drug use)\n5. Willing to comply with the schedule and sign the informed consent\n6. Participants with moderate renal impairement\n\nExclusion Criteria:\n\n1. Participants scheduled for emergent or salvage cardiac surgery\n2. Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI)\n3. Participants at risk of bleeding\n4. Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease\n5. Participants who received cardiopulmonary resuscitation within 30 days prior to cardiac surgery\n6. Recipient of a solid organ or bone marrow transplantation\n7. Participants with cardiogenic shock or hemodynamics instability, or planned use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device\n8. Active systemic bacterial, viral, or fungal infection\n9. History of HIV\n10. Positive serology test for HAV, HBV, HCV or Syphilis\n11. Participants with impaired liver function due to cirrhosis, or those with 2x UNR blood levels of ALP, AST, or ALT, or with total bilirubin levels outside the normal range\n12. Uncontrolled hypertension\n13. History of congenital immunodeficiency\n14. Genetic disorder with severe and abnormal bilirubin metabolism\n15. Participants deemed unsuitable for the study in the discretion of the investigator\n16. History of malignancy\n17. Planned use of any pharmacologic agent other than the IP assigned in this study for the prevention or treatment of acute kidney injury\n18. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents\n19. History of participation in other clinical trials within 30 days\n20. Presence of a do-not-resuscitate order or life expectancy of \\\u003C 3 months\n21. Female subjects of childbearing potential\n22. Male subjects and their spouse\u002Fpartner are not willing to use appropriate contraception, or if their spouse\u002Fpartner is pregnant, breastfeeding or has a plan\n23. Poorly controlled type 2 diabetes mellitus\n24. New York Heart Association (NYHA) Class IV heart failure","ALL","19 Years","90 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a clinical trial of BX-001N to prevent patients from Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and subsequent Major Adverse Kidney Events (MAKE) in approximately 50 participants.",[27,28],"Ischemia Reperfusion Injury","Cardiac Surgery Associated - Acute Kidney Injury","RECRUITING","2026-06-28",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2025-08-26",{"date":37,"type":21},"2028-04",{"name":39,"class":40},"Bilix Co.,Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100625100","prognostic-value-of-novel-biomarkers-on-adverse-renal-outcomes-in-high-risk-cardiac-surgery-patients-100625100","NCT07418242","Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients","Prognostic Value of Novel Biomarker on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients","Adult patients were included in the study if they were scheduled for elective open chest cavity cardiac surgeries, with or without the use of cardiopulmonary bypass (CPB). Inclusion criteria required that patients undergoing surgery with CPB must have at least one AKI risk factor, whereas those undergoing surgery without CPB needed to have at least two AKI risk factors.\n\nThe AKI risk factors were as follows:\n\n* age \\>70 years;\n* 30 \\\u003C estimated glomerular filtration rate (eGFR) \\\u003C60 mL·min-1·1.73 m-2;\n* diabetes mellitus, proteinuria;\n* a history of congestive heart failure within the previous year;\n* a left ventricular ejection fraction of 40% or lower;\n* prior cardiac surgery;\n* combined coronary artery bypass\u002Fvalve procedure;\n* urgent procedure;\n* preoperative intra-aortic balloon pump.\n\nExclusion criteria:\n\n* pre-existing chronic kidney disease (preoperative estimated glomerular filtration rate \\[eGFR\\] \\\u003C 30 mL\u002Fmin\u002F1.73 m2);\n* previous RRT before cardiac surgery;\n* present AKI at screening;\n* a history of kidney transplant or other kidney diseases;\n* known pregnancy;\n* multiple operation during the hospital stay;\n* being in a moribund state (with an anticipated likelihood of death within 48 hours).","18 Years",{"count":50,"type":21},1491,"OBSERVATIONAL","This project aims to detect novel biomarkers from preoperative and early postoperative serum and urine samples of patients to screen and analyze the risk factors for predicting adverse postoperative renal outcomes in high-risk patients in cardiac surgery.",[28,54],"Critical Illness",[56,57,58,59,60,28],"Acute kidney injury","Biomarker","Poor outcome","AKI occurrence","Prognostic value","2026-05-14",{"date":63,"type":33},"2026-05-18",{"date":65,"type":33},"2026-02-23",{"date":67,"type":21},"2029-05-31",{"name":69,"class":70},"Guowei Tu","OTHER",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100634781","inhaled-nitric-oxide-for-prevention-of-postoperative-aki-in-high-risk-cardiac-surgery-patients-100634781","NCT07544147","Inhaled Nitric Oxide for Prevention of Postoperative AKI in High-Risk Cardiac Surgery Patients","Intraoperative Inhaled Nitric Oxide to Reduce Postoperative Acute Kidney Injury in High-Risk Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass","Inclusion Criteria:\n\n* Age ≥18 years\n* Scheduled for elective cardiac surgery with cardiopulmonary bypass, including valve surgery and\u002For coronary artery bypass grafting (CABG)\n* Mayo Clinic renal risk score ≥2\n\nExclusion Criteria:\n\n* Emergency surgery\n* Cardiac or major vascular surgery requiring deep hypothermic circulatory arrest\n* Use of potentially nephrotoxic drugs (e.g., radiocontrast agents, aminoglycosides, amphotericin) within 24 hours before surgery\n* Preoperative heart failure or low cardiac output syndrome requiring life support devices (ECMO, Impella or other left ventricular assist devices, mechanical ventilation), or left ventricular ejection fraction \\\u003C30%, or other equivalent severe cardiac dysfunction\n* Receipt of inhaled nitric oxide or inhaled prostacyclin within 7 days before randomization\n* End-stage renal disease with eGFR \\\u003C15 mL\u002Fmin, or currently receiving renal replacement therapy, or prior kidney transplantation\n* Hemophilia A or B\n* Other end-stage chronic disease with estimated life expectancy \\\u003C1 year (as assessed by the attending physician)\n* Pregnancy\n* Active endocarditis or other active infection",{"count":80,"type":21},330,[82],"NA","The goal of this clinical trial is to learn if giving inhaled nitric oxide during heart surgery can prevent acute kidney injury (AKI) in patients who are at high risk of developing this complication. AKI is a serious problem after heart surgery and can lead to longer hospital stays, higher costs, and increased risk of death or long-term kidney disease. Currently, there is no effective medicine to prevent AKI after heart surgery.\n\nThe main questions it aims to answer are:\n\n* Does inhaled nitric oxide reduce the chance of developing AKI within 7 days after heart surgery compared to placebo?\n* Does inhaled nitric oxide help preserve kidney function up to 90 days after surgery?\n\nResearchers will compare inhaled nitric oxide (the device is turned on) to a placebo (the same device is connected to the breathing circuit but not turned on, so no nitric oxide is given). The device panel is covered so that both participants and the research team do not know who receives active treatment or placebo (double-blind).\n\nParticipants in this study will:\n\n* Have the nitric oxide device connected to their breathing circuit during heart surgery; they will receive either active nitric oxide or no nitric oxide (device off)\n* Provide blood and urine samples to test kidney function during and after surgery\n* Be followed for 90 days after surgery to monitor kidney health and any side effects",[28,85],"Cardiac Surgery With Cardiopulmonary Bypass",[87,88,89,90,91],"Acute Kidney Injury","Nitric Oxide","Cardiac surgery","Cardiopulmonary Bypass","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-04-19",{"date":95,"type":33},"2026-04-22",{"date":97,"type":21},"2026-04-30",{"date":99,"type":21},"2028-12-31",{"name":101,"class":70},"Shanghai Zhongshan Hospital",1,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":18,"enrollmentInfo":109,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":102},"100633061","prognostic-value-of-metabolic-characteristics-in-high-risk-populations-for-acute-kidney-injury-after-cardiac-surgery-100633061","NCT07521787","Prognostic Value of Metabolic Characteristics in High-Risk Populations for Acute Kidney Injury After Cardiac Surgery","Inclusion Criteria:\n\n* All patients is going to undergo non-emergency cardiac surgeries, including cardiopulmonary bypass or non-cardiopulmonary bypass surgeries;\n* Patients must have the risk of developing AKI, and at least meet one of the following criteria: cardiopulmonary bypass cardiac surgery + at least one risk factor; or non-cardiopulmonary bypass surgery such as simple coronary artery bypass grafting + at least two AKI risk factors.\n\nThe risk factors includes:\n\n* Age ≥ 70 years;\n\n  * Diabetes (type 1 or type 2), requiring at least one oral hypoglycemic drug or insulin;\n\n    * 30 ≤ eGFR ≤ 60 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula);\n\n      * Recorded history of proteinuria (random urine albumin-to-creatinine ratio UACR \\> 30 mg\u002Fg, or 24-hour urine albumin \\> 300 mg\u002F24 hours, or urine protein ≥ +1 in urine test strips\u002Furine routine tests);\n\n        * Previous history of hospitalization for congestive heart failure or NYHA classification III\u002FIV;\n\n          * Left ventricular ejection fraction (LVEF) ≤ 40%; ⑦ Previous history of open-chest cardiac surgery;\n\n            * CABG combined with valve surgery; ⑨ Surgery involving more than one heart valve; ⑩ Emergency surgery; ⑪ Preoperative IABP\n\nExclusion Criteria:\n\n* There were urgent indications for initiating RRT at the time of enrollment, including serum potassium ≥ 6.0 mmol\u002FL, pH value ≤ 7.20, serum bicarbonate ≤ 12 mmol\u002FL, oxygenation index ≤ 200 mmHg; presence of volume overload, severe respiratory failure, etc.;\n* Preoperative end-stage CKD (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2; or RRT treatment had been received within 4 weeks before enrollment);\n* AKI was present at screening. But transient (≤ 5 days) stage 1 AKI after iodinated contrast agent exposure will be included in this study.\n* Previous kidney transplantation or urinary tract obstruction and other urinary system diseases;\n* End-stage heart disease, HIV infection, hematological tumors, etc.,\n* with an expected survival period of \\\u003C 1 year;\n* being in a moribund state (with an anticipated likelihood of death within 48 hours);\n* Multiple transfers to ICU;\n* Pregnant or lactating women;\n* Medical or psychological conditions that the investigator believed might interfere with the subject's participation in the study, or confuse the subject's assessment or study outcome.",{"count":110,"type":21},540,"This project aims to explore the metabolic characteristics of adverse renal outcomes in high-risk populations after cardiac surgery by using multi-omics techniques, in order to understand the metabolic changes in patients during the process of renal function decline and recovery. At the same time, this project will search for combinations of metabolic markers that predict the occurrence of adverse outcomes, establish predictive models, to help clinical early identification and warning of AKI, and implement prevention and intervention strategies, thereby improving the prognosis of patients and enhancing the safety and success rate of cardiac surgery.",[28,54],[56,57,114,58,60,115],"Metabolic characteristics","Cardiac surgery associated AKI","2026-04-07",{"date":118,"type":33},"2026-04-13",{"date":120,"type":21},"2026-04-23",{"date":122,"type":21},"2029-12-30",{"name":101,"class":70},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":71},"100602471","safety--efficacy-of-renalguard-therapy-in-the-prevention-of-cardiac-surgery-associated-acute-kidney-injury-100602471","NCT07123935","Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury","Assessing the Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) - SAFEGUARD Study","SAFEGUARD","Inclusion Criteria:\n\n1. Male or female and \\>18 years old.\n2. Patient able to give written consent.\n3. Scheduled for the following non-emergent cardiac surgery procedure requiring CPB, isolated or in combination:\n\n   * coronary artery bypass graft (CABG)\n   * aortic valve replacement or repair alone, with or without aortic root repair\n   * mitral, tricuspid, or pulmonic valve replacement or repair\n   * simultaneous replacement of several cardiac valves\n   * CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair\n   * Surgery on the aorta: aortic root and\u002F or ascending aorta\n   * AF ablation surgery if combined with other cardiac procedures.\n   * ASD closure if combined with other cardiac procedures.\n   * Excision of myxoma if combined with other cardiac procedures\n4. Have at least one of the following risk factors for CSA-AKI:\n\n   * CKD-EPI eGFR 20-59 mL\u002Fmin\u002F1.73 m²\n   * Undergoing combined surgery (e.g. CABG + Valve)\n   * STS Score ≥4 or Logistic EuroScore of ≥5 or, Euroscore II of ≥4\n   * Left ventricular ejection fraction (LVEF) ≤ 35%\n   * Insulin-requiring diabetes\n   * Non-insulin-requiring diabetes with HbA1C ≥ 6.1% in the last 6 months\n   * Preoperative anemia (hemoglobin ≤11g\u002Fdl for men and women) within 4 weeks of surgery\n\nExclusion Criteria:\n\n1. Patient requiring emergency surgery\n2. Surgery to be performed without CPB\n3. Patient receiving furosemide at a dose\\>100 mg\u002Fday orally (or the equivalent dose of an alternative loop diuretic) in the last week\n4. Patient who cannot be urethrally catheterize for any reason\n5. Patients already dialysis dependent\n6. Patients with CKD-EPI eGFR \\\u003C20 mL\u002Fmin\u002F1.73 m²\n7. Known or suspected AKI (KDIGO criteria) at the time of screening\n8. IV contrast within 48 hours of surgery\n9. Patients participating in another interventional drug or device study or have received an investigational drug or device treatment within the last 30 days\n10. Pregnant patient, self-reported\n11. Patients whose planned surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature \\\u003C 28°Celsius (82.4° Fahrenheit)\n12. Patient with suspected or confirmed bacteraemia, endocarditis, or pyelonephritis at hospital admission\n13. Patients with pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious aetiology reported on chest x-ray or CT scan in the last 7 days\n14. Patients in cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices (Impella, IABP) within 24 hours prior to surgery\n15. Patients on extracorporeal membrane oxygenation (ECMO) or durable ventricular assist device (VAD) at the time of screening, or planned use within 24h prior to surgery\n16. Patients currently treated with chemotherapy or radiation therapy that may have an impact on kidney function.\n17. Patient underwent prior solid organ transplantation\n18. Patients underwent major surgery within the last 3 months\n19. Any condition which, in the judgement of the investigator, might increase the risk to the patient",{"count":133,"type":21},300,[82],"The goal of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated AKI (CSA-AKI) compared to standard-of-care (SoC).\n\nThe study is planned to be conducted in 2 clinical sites in the Malaysia - Universiti Malaya Medical Centre and Institut Jantung Negara, Kuala Lumpur, Malaysia.\n\nParticipants will be randomized (1:1) to one of the two study groups. The Treatment study group will be managed with the RenalGuard System. The RenalGuard treatment will start after induction of anesthesiology and will run during surgery and for 6-7 hours in the Intensive Care Unit (ICU). The treatment will aim to achieve a urine rate above a predefined urine rate threshold. Patients in the control group will be managed based on the usual clinical practice in cardiac surgery centres as detailed in the recommendations for CSA-AKI prevention by accepted clinical guidelines.\n\nFor both study groups general anaesthesia, cardiopulmonary bypass (CPB) run and overall patient care will be based on SoC for cardiac surgery.\n\nPatients will be followed up for up to 7 days post surgery or until discharge, which ever comes first.\n\nLong-term follow up will be performed at 90 days post surgery.",[28,137],"AKI - Acute Kidney Injury",[139,140,141,142],"acute kidney injury","cardiac surgery","RenalGuard Therapy","matched enhanced diuresis","2025-08-12",{"date":145,"type":33},"2025-08-14",{"date":147,"type":21},"2025-09-01",{"date":149,"type":21},"2027-06-30",{"name":151,"class":40},"CardioRenal Systems, Inc.",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":158,"targetDuration":160,"studyType":51,"phases":4,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":102},"100570331","a-comparison-of-renal-vs-limb-nirs-for-predicting-cardiac-surgery-associated-acute-kidney-injury-100570331","NCT06705855","A Comparison of Renal vs Limb NIRS for Predicting Cardiac Surgery Associated Acute Kidney Injury","Inclusion Criteria:\n\n* We will enroll a convenience sample of adult cardiac surgery patients undergoing procedures that require cardiopulmonary bypass (CPB) and who are at risk for AKI.\n\nExclusion Criteria:\n\n* Exclusion criteria will include less than age 18 years old, preoperative end-stage kidney disease requiring dialysis, emergency surgery, or patient refusal.",{"count":159,"type":21},100,"30 Days","Acute kidney injury (AKI) is a complication of cardiac surgery that can affect outcome. Near Infrared Spectroscopy (NIRS) is a technology that uses light to determine how well oxygenated tissues are. This technology is routinely used in cardiac surgery to measure the oxygen level in the brain by placing a sensor sticker on the forehead. The purpose of the study is to determine whether NIRS sensor stickers placed on the skin over the kidney can predict AKI better than when sensors are placed on the skin over the participant's limbs. This study is being conducted by investigators from the department of anesthesiology at the University of Utah.",[163,28,164,137],"NIRS","Cardiac Surgery Requiring Cardiopulmonary Bypass",[166],"Cardiovascular",{"date":168,"type":33},"2025-08-17",{"date":170,"type":33},"2025-05-29",{"date":172,"type":21},"2026-08-30",{"name":174,"class":70},"University of Utah",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":102},"100590796","prevention-and-treatment-of-aki-vexus-guided-post-cardiac-surgery-100590796","NCT06972082","Prevention and Treatment of AKI VEXUS Guided Post Cardiac Surgery","Prevention and Treatment of Acute Kidney Injury After Cardiac Surgery Guided by Combined Cardiac and Splanchnic Sonographic Assessment","VEXAKI","Inclusion Criteria:\n\n* Patients in the Cardiac Surgery ICU who develop acute kidney injury according to KDIGO criteria, within 48 hours of ICU admission after cardiac surgery\n* Elective and non-elective cardiac surgery.\n\nExclusion Criteria:\n\n* Patient refusal\n* Severe chronic renal failure (GFR\\\u003C15 mL\u002Fmin\u002Fm2 or on hemodialysis).\n* Critical preoperative condition (severe cardiogenic shock, resuscitated cardiac arrest, support with mechanical circulatory assist devices).\n* Liver cirrhosis or inferior vena cava obstruction.\n* Pregnancy.\n* Morbid obesity (BMI\\>40 kg\u002Fm2).\n* Delirium or other condition that prevents the performance of an ultrasound study.",{"count":184,"type":21},304,[82],"The main goal of this clinical trial is to learn if evaluation by ultrasound of venous congestion of liver and kidneys can guide treatment and prevent and treat acute kidney injury post cardiac surgery (CSA-AKI).\n\nParticipants will:\n\nBe evaluated by liver and kidney veins ultrasound (treatment group) or a placebo post CSA-AKI.\n\nFluid management for the treatment group will be based on a score that emerges from this evaluation (Venous Excess Ultrasound Score, VEXUS).\n\nKidney function will be daily monitored and followed-up for 7 days and until discharge.\n\nDaily fluid balance and laboratory examination will be performed. Data will be recorded and collected and a statistical analysis will provide the results that will show or not a probable superiority of this evaluation comparing to the usual care.",[87,28],"2025-05-06",{"date":190,"type":33},"2025-05-14",{"date":192,"type":33},"2023-06-29",{"date":194,"type":21},"2025-10",{"name":196,"class":70},"Onassis Cardiac Surgery Centre",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":102},"100564702","phase-2-efficacy-and-safety-of-enn0403-in-patients-at-high-risk-for-acute-kidney-injury-following-elective-cardiac-surgery-100564702","NCT06632613","Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery","A Phase 2 Clinical Study Evaluating the Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery Requiring Cardiopulmonary Bypass","Inclusion Criteria:\n\n1. Ability to understand and comply with the study requirements and able to provide written informed consent;\n2. Age ≥18 and ≤85 years;\n3. Male subjects (and their fertile female spouses\u002Fpartners) do not have pregnancy plans during the screening period and within 3 months after the last dose, voluntarily take highly effective contraception, and must not donate sperm or ova. Only non-fertile women will be enrolled, and female subjects who meet the following criteria are not considered fertile: Postmenopausal status has been achieved, normal menstruation has stopped for at least 12 consecutive months with an FSH \\>30 IU\u002FL in the absence of other pathophysiological causes, or there is a medical record showing hysterectomy \\\\ bilateral tubal resection and\u002For bilateral ovariectomy.\n4. Subjects must be scheduled for cardiac surgery requring cardiopulmonary bypass: Coronary artery bypass grafting (CABG) and\u002For heart valve surgery and\u002For aortic root, ascending aorta and aortic arch surgery;\n5. Subjects have the risk of developing AKI with at least one of the following criteria: coronary artery bypass grafting combined with one or more heart valves surgery plus at least one risk factor for AKI; Multiple heart valves surgery plus at least one AKI risk factor; Coronary artery bypass grafting or aortic valve surgery combined with aortic root, ascending aorta, and aortic arch surgery (non-aortic dissection) plus at least one risk factor for AKI; Coronary artery bypass grafting alone or single heart valve surgery plus at least 2 risk factors for AKI.\n\nExclusion Criteria:\n\n1. Receive ICD or permanent pacemaker implantation, mechanical ventilation, IABP, LVAD or other mechanical circulatory AIDS within 1 week before surgery;\n2. Cardiopulmonary resuscitation is performed within 14 days prior to screening;\n3. Abnormal renal function with eGFR\\\u003C20 mL\u002Fmin\u002F1.73 m2 within 30 days before screening;\n4. Receive renal replacement therapy or the presence of AKI within 30 days before surgery, except for transient (≤5 days) stage 1 AKI after iodized contrast agent exposure;\n5. Participate in other clinical trials within the past 1 month;\n6. Have a known allergy to investigational drug or any of its constituents, or allery to any constituents used during the study;\n7. Subjects with intractable hypotension, severe hypoxemia or other emergency during surgery.","85 Years",{"count":206,"type":21},200,[24],"The is a two-stage study. Stage 1 is to evaluate the safety, tolerability, PK and PD of ENN0403 in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass. Stage 2 is to evaluate the efficacy, safety, PK and PD of ENN0403 to prevent and treat AKI after multiple administraions in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass.",[28],"2025-01-09",{"date":212,"type":33},"2025-01-13",{"date":214,"type":33},"2024-11-05",{"date":216,"type":21},"2026-03",{"name":218,"class":40},"EnnovaBio"]