[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lung-injuryacute-respiratory-distress-syndrome-ards\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lung-injuryacute-respiratory-distress-syndrome-ards":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,71,97],{"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":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100555581","phase-2-anti-cd14-treatment-with-ic14-in-hospitalized-ards-patients-100555581",false,"NCT06513949","Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients","Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Anti-CD14 Treatment With a Recombinant Chimeric Monoclonal Antibody (IC14) in Hospitalized Patients With Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\nPatients may be included in the study only if they meet all the following criteria:\n\n1. Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours)\n\n   1. P:F ratio \\\u003C 300\n   2. Positive end-expiratory pressure (PEEP) ≥5 cm H2O\n   3. Bilateral opacities on chest x-ray or chest computerized tomography (CT)-- not fully explained by effusions, lobar\u002Flung collapse, or nodules\n   4. Respiratory failure not fully explained by cardiac failure or fluid overload\n   5. Within 1 week of known clinical insult or new or worsening respiratory symptoms\n\n   i. Common Risk Factors for ARDS: Pneumonia, aspiration, inhalation injury, pulmonary contusion, pulmonary vasculitis, drowning, non-pulmonary sepsis, major trauma, pancreatitis, severe burns, non-cardiogenic shock, drug overdose, multiple transfusions\n2. Patient or Legal authorized representative able to understand and give written informed consent\n\nExclusion Criteria:\n\nAn individual fulfilling any of the following criteria should be excluded from enrollment in the study:\n\n1. Significant pre-existing organ dysfunction prior to hospitalization\n\n   1. Lung: Currently receiving home oxygen therapy as documented in medical record\n   2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \\\u003C20% as documented in the medical record\n   3. Renal: End-stage renal disease requiring renal replacement therapy or estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin.\n   4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or hepatic transaminases \\>5 times upper limit of normal\n   5. Hematologic: Baseline platelet count \\\u003C50,000\u002Fmm3\n2. Presence of co-existing infection, including, but not limited to:\n\n   1. HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell\u002Fmm3\n   2. Active tuberculosis or a history of inadequately treated tuberculosis\n   3. Active hepatitis B or hepatitis C viral infection\n3. Current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi®), anakinra (Kineret®), rilonacept (Arcalyst®), tocilizumab (Actemra®), sarilumab (Kevzara®), siltuximab (Sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments\n4. Receiving comfort measures only\n5. Requiring \\>2 vasopressors\n6. Pregnant\n7. Prisoners\n8. History of hypersensitivity or idiosyncratic reaction to IC14\n9. Women who are currently breastfeeding\n10. Bronchoscopy safety exclusions\n\n    1. P:F \\\u003C100 on 100% FiO2\n    2. Mean pulmonary artery pressure \\> 55 mmHg\n    3. Marked cardiovascular instability (Mean arterial pressure \\\u003C55 mmHg with vasopressor support)\n    4. Intracranial pressure ≥20 mmHg\n    5. Acute ischemic heart disease (unstable angina or ST-elevation myocardial infarction or Type 1 non-ST-elevation myocardial infarction)\n    6. Supported on extracorporeal membrane oxygenation\n    7. Endotracheal tube \\\u003C6.5 mm","ALL","18 Years",{"count":19,"type":20},56,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Hospitalized patients with ARDS will be randomized to intravenous treatment with a monoclonal antibody against CD14, called IC14, or placebo. They will be followed for 28 days.\n\nThe primary outcome is the day 4 oxygenation index assessed as a continuous measure.",[26,27,28,29],"Acute Respiratory Distress Syndrome","Adult Respiratory Distress Syndrome","Acute Lung Injury","Acute Lung Injury\u002FAcute Respiratory Distress Syndrome (ARDS)",[31,32],"ARDS","IC14","RECRUITING","2025-08-15",{"date":36,"type":37},"2025-08-20","ACTUAL",{"date":34,"type":37},{"date":40,"type":20},"2027-12",{"name":42,"class":43},"Implicit Bioscience","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100525609","aliards-clinical-sub-phenotyping-study-100525609","NCT06123962","ALI\u002FARDS Clinical Sub-phenotyping Study","Acute Lung\u002F Acute Respiratory Distress Syndrome and Extra-pulmonary Organ Injury Clinical Sub-phenotyping Study","Inclusion Criteria:\n\n* Meet the diagnostic criteria for Acute Respiratory Distress Syndrome (ARDS) according to the updated global definition in 2023.\n* The patient or their legal representative signs an informed consent form.\n\nExclusion Criteria:\n\n* Individuals aged less than 18 years old.\n* Those who refuse to participate in the study.",{"count":53,"type":20},1500,"OBSERVATIONAL","1. Construct a structured clinical data and biosample information platform for Chinese patients with acute lung injury\u002F acute respiratory distress syndrome.\n2. By deciphering the heterogeneity of patients with acute lung injury\u002F acute respiratory distress syndrome, achieve clinical, longitudinal physiological, and biological sub-phenotyping to guide individualized precision treatment and improve prognosis.",[29],[29,58,59],"Sub-phenotypes","Treatment strategies","2025-02-10",{"date":62,"type":37},"2025-02-12",{"date":64,"type":37},"2023-12-14",{"date":66,"type":20},"2025-12-31",{"name":68,"class":69},"China-Japan Friendship Hospital","OTHER",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":70},"100577985","vexus-in-ards-patients-and-association-with-aki-100577985","NCT06805409","VExUS in Ards Patients and Association with AKI","Evaluation of Venous Congestion Using Doppler and Venous Excess Ultrasound Score (VExUS) During Acute Respiratory Distress Syndrome and Its Association with Acute Kidney Injury","VEXAKI","Inclusion Criteria:\n\n* Patients ≥18 years old\n* Moderate to severe ARDS according to the Berlin definition\n* Requiring catecholamine support\n* Undergoing invasive mechanical ventilation for less than 48 hours\n\nExclusion Criteria:\n\n* Patients presenting with acute kidney injury KDIGO III requiring renal replacement therapy before the initial ultrasound evaluation\n* Requirement for veno-venous or veno-arterial ECMO circulatory support before inclusion\n* Patients with end-stage chronic kidney disease, on dialysis, and\u002For kidney transplant recipients\n* History of Child C cirrhosis and\u002For liver transplantation and\u002For portal hypertension\n* History of portal thrombosis\n* Known history of pulmonary hypertension\n* Pregnant women\n* Patients under legal protection\n* Patients who have expressed opposition to participating in the research","100 Years",{"count":81,"type":20},120,"A single-center prospective observational study will be conducted with the aim of determining the prevalence of venous congestion during ARDS using venous Doppler and the VExUS score.",[29],[85,86,87],"Acute respiratory distress syndrome","acute kidney injury","Venous Congestion","2025-01-30",{"date":90,"type":37},"2025-02-03",{"date":92,"type":37},"2024-12-02",{"date":94,"type":20},"2027-12-09",{"name":96,"class":69},"Assistance Publique - Hôpitaux de Paris",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":70},"100439452","infants-with-severe-acute-respiratory-distress-syndrome-the-prone-trial-100439452","NCT05002478","Infants with Severe Acute Respiratory Distress Syndrome: the Prone Trial","Short-Term Effect of Prone Positioning in Infants with Severe Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n* Patients hospitalized at Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) of the Medical University Vienna.\n* Patients aged \\>36 weeks (corrected gestational age) and \\\u003C24 months.\n* Patient intubated and mechanically ventilated for at least 6 hours, with an expected requirement of invasive ventilatory support for at least 12 hours.\n* Clinical picture strongly suggestive for acute bronchiolitis or pneumonia (fever, fine crackles, prolonged expiration, lung hyperinflation and\u002For findings of new infiltrates consistent with acute pulmonary parenchymal disease on chest X-ray).\n* Severe pediatric acute respiratory distress syndrome (ARDS), defined by OSI ≥12.3 (wean FIO2 to maintain SpO2 ≤ 97% to calculate oxygen saturation index).\n* Written informed consent obtained from parents.\n\nExclusion Criteria:\n\n* Clinical context\n\n  * Need for O2 supplementation to maintain SpO2\\>94% in the 4 weeks preceding hospitalization in the PICU\u002FNICU\n  * Cyanotic congenital heart disease Cardiogenic pulmonary edema\n  * Severe pulmonary hypertension\n  * Untreated pneumothorax\n  * Severe neurological abnormalities\n  * Other severe congenital anomalies such as congenital diaphragmatic hernia\n  * Ongoing cardiopulmonary resuscitation or limitation of life support\n* Contradictions for prone positioning (adapted from Guerin, C., et al., Prone positioning in severe acute respiratory distress syndrome. N Engl J Med, 2013. 368(23): p. 2159-68):\n\n  * Intracranial pressure \\>30 millimeters of mercury (mmHg) in supine position or cerebral perfusion pressure \\\u003C60 mmHg\n  * Massive hemoptysis requiring an immediate surgical or interventional radiology procedure\n  * Tracheal surgery or sternotomy during the previous 15 days\n  * Serious facial trauma or facial surgery during the previous 15 days\n  * Deep venous thrombosis treated for less than 2 days\n  * Cardiac pacemaker inserted in the last 2 days\n  * Unstable spine, femur, or pelvic fractures\n  * Use of extracorporeal membrane oxygenation (ECMO) before inclusion\n  * Lung transplantation\n  * Burns on more than 20% of the body surface\n* Other non-inclusion criteria\n\n  * Indication not to attempt resuscitation\n  * Patient already recruited for other clinical studies\n  * Patients who already received surfactant in the last 4 weeks\n  * Thoracic skin lesions or wounds on the thorax, where the EIT-electrode-belt would be placed","12 Months",{"count":106,"type":20},14,[108],"NA","The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome. The investigators compare oxygenation parameters and measurements from electrical impedance tomography (EIT) and lung ultrasonography (LUS) in mechanically ventilated infants in prone position versus supine position after surfactant administration.",[29,111,112],"Surfactant Dysfunction","Infant",[26,114,115,116,117],"Electrical Impedance Tomography","Lung Ultrasonography","Prone Position","Infants","2024-11-18",{"date":120,"type":37},"2024-11-20",{"date":122,"type":37},"2022-07-30",{"date":124,"type":20},"2026-12-31",{"name":126,"class":69},"Medical University of Vienna"]