[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bin Du\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100643136","phase-4-mgfr-vs-tgfr-in-aki-100643136",false,"NCT07632469","mGFR vs tGFR in AKI","Comparison of Agreement Between mGFR and tGFR in ICU Patients With Acute Kidney Injury","Inclusion Criteria:\n\n* CU stay ≤ 72 hours;\n* meets KDIGO AKI criteria;\n* age 18-85 years;\n* able to complete blood\u002Furine collection and monitoring\n\nExclusion Criteria:\n\n* prior history of CKD stage 4 or higher;\n* anuria;\n* recent contrast agent exposure or kidney transplant history;\n* pregnancy or breastfeeding; expected survival \\\u003C 24 hours.","ALL","18 Years","85 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this study is to learn if the TGFR device (which uses telmapirazin to continuously measure real-time GFR) works to provide accurate and dynamic kidney function assessment in critically ill adults with acute kidney injury (AKI). It will also learn how tGFR compares with the gold standard measured GFR (mGFR) and other commonly used estimate methods. The main questions it aims to answer are:\n\n* Does tGFR show good agreement with mGFR over the 0-12 hour period in AKI patients?\n* How do tGFR, mGFR, 4-hour creatinine clearance, kinetic GFR (keGFR), and CKD-EPI eGFR compare across different AKI stages?\n* What are the bias and variability of each method over time?\n\nResearchers will compare tGFR to mGFR (iohexol clearance) to see if tGFR is a reliable alternative for bedside, continuous GFR monitoring. They will also compare tGFR against 4-hour creatinine clearance, keGFR, and eGFR to assess consistency across AKI stages.\n\nParticipants will:\n\n* Wear a single-use tGFR sensor patch on the chest for continuous GFR monitoring\n* Receive iohexol injection for mGFR measurement (gold standard)\n* Provide blood and urine samples for 4-hour creatinine clearance and other tests\n* Undergo repeated GFR assessments over the 12-hour study period",[27,28],"AKI","GFR",[30,31,32],"acute kidney injury","intensive care","glomerular filtration rate","NOT_YET_RECRUITING","2026-06-06",{"date":36,"type":37},"2026-06-10","ACTUAL",{"date":39,"type":21},"2026-06-08",{"date":41,"type":21},"2027-05-05",{"name":43,"class":44},"Bin Du","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100632276","phase-2-corticosteroids-in-hyperinflammatory-phenotype-of-critical-illness-100632276","NCT07511582","Corticosteroids in Hyperinflammatory Phenotype of Critical Illness","Efficacy, Safety, and Tolerability of Methylprednisolone in Critically Ill Patients With the Hyperinflammatory Phenotype: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Trial","CHIP","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Age ≥18 years.\n2. Diagnosis of acute respiratory distress syndrome (ARDS) or sepsis.\n\nARDS will be defined according to standard criteria:\n\n1. acute onset within 1 week of a known clinical insult or new\u002Fworsening respiratory symptoms;\n2. bilateral pulmonary opacities on chest imaging (X-ray or CT) or bilateral B-lines and\u002For consolidation on lung ultrasound, not fully explained by effusion, atelectasis, or nodules;\n3. respiratory failure not fully explained by cardiac failure or fluid overload;\n4. hypoxemia defined as PaO₂\u002FFiO₂ ≤300 mmHg or SpO₂\u002FFiO₂ ≤315 (with SpO₂ ≤97%) under a minimum positive end-expiratory pressure (PEEP) of 5 cmH₂O.\n\nSepsis will be defined according to the Sepsis-3 criteria as suspected or confirmed infection with an acute increase in SOFA score ≥2 points, assuming a baseline SOFA score of 0 in patients without known prior organ dysfunction.\n\nSepsis-associated ARDS will be defined as ARDS occurring in patients with sepsis.\n\n3\\. Receiving invasive mechanical ventilation. 4. Admission to the intensive care unit (ICU). 5. Hyperinflammatory phenotype, defined as a predicted probability ≥0.5 using a validated AI clinical classifier based on clinical data.\n\n6\\. Randomization within 72 hours of ARDS or sepsis onset. 7. Provision of written informed consent by the patient or their legally authorized representative.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Requirement for high-dose vasopressor support, defined as norepinephrine ≥0.5 μg\u002Fkg\u002Fmin or epinephrine ≥0.25 μg\u002Fkg\u002Fmin.\n2. Post-cardiac surgery patients (e.g., coronary artery bypass grafting or valve replacement).\n3. Conditions requiring systemic corticosteroid therapy exceeding 1 mg\u002Fkg methylprednisolone or an equivalent dose (e.g., acute asthma exacerbation, acute exacerbation of chronic obstructive pulmonary disease, or autoimmune diseases).\n4. Long-term systemic corticosteroid use within the past 6 months.\n5. Pregnancy or lactation.\n6. Brain death.\n7. Advanced malignancy or other end-stage disease with an expected survival of less than 6 months, or anticipated death within 24 hours.\n8. Known hypersensitivity to methylprednisolone, including but not limited to urticaria, eczema, angioedema, bronchospasm, or anaphylaxis.\n9. History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n10. Active life-threatening fungal infection or tuberculosis.\n11. Neuromuscular disorders affecting spontaneous respiration.\n12. Severe inherited or acquired immunodeficiency (e.g., human immunodeficiency virus infection, chronic granulomatous disease, or severe combined immunodeficiency).\n13. Do-not-resuscitate (DNR) orders or withdrawal of life-sustaining treatment.\n14. Concurrent participation in another interventional clinical trial.\n15. Any other condition that, in the opinion of the treating physician or investigator, would make participation in the study inappropriate.",{"count":54,"type":21},150,[56],"PHASE2","The goal of this clinical trial is to learn whether methylprednisolone improves outcomes in critically ill patients with a hyperinflammatory phenotype. It will also evaluate the safety of methylprednisolone at different doses.\n\nThe main questions it aims to answer are:\n\n* Does methylprednisolone improve organ function compared with placebo?\n* Does methylprednisolone reduce the risk of mortality within 30 days?\n\nResearchers will compare high-dose methylprednisolone (160mg\u002Fd), low-dose methylprednisolone (80mg\u002Fd), and placebo (normal saline) to evaluate effectiveness and safety.\n\nParticipants will:\n\n* Receive high-dose methylprednisolone, low-dose methylprednisolone, or placebo every 12 hours for the first 3 days\n* Be reassessed on Day 4 based on their inflammatory status If the hyperinflammatory phenotype persists, the treatment dose will be reduced by half and continued until Day 7 or ICU discharge, whichever occurs first If the patient transitions to a hypoinflammatory phenotype, the study treatment will be discontinued\n* Be monitored daily in the intensive care unit for organ function, inflammatory status, and need for organ support\n* Be followed for up to 30 days after randomization to assess survival and recovery",[59,60],"Sepsis","Acute Respiratory Distress Syndrome",[62,63,59,64],"Corticosteroids","Hyperinflammatory phenotype","Acute respiratory distress syndrome","RECRUITING","2026-05-21",{"date":68,"type":37},"2026-05-26",{"date":70,"type":37},"2026-04-15",{"date":72,"type":21},"2028-06-01",{"name":43,"class":44},1,""]