[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484735":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":44,"locations":50,"responsibleParty":68,"collaborators":70,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":9,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":10,"enrollmentInfo":86,"targetDuration":89,"studyType":90,"phases":10,"briefSummary":91,"conditions":92,"keywords":102,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"ESTABLISH",null,"Adults over 18 years of age admitted to the ICU within 48 hours and whose presentation to the Emergency Department was within 72h of ICU admission.",[13,14,15,16],"Procedure: Phelebotomy","Procedure: Broncheoalveolar Lavage","Procedure: Tracheal Aspirate","Procedure: Rectal Swab",{"label":18,"type":10,"description":19,"interventionNames":20},"Healthy Controls","Adults over 18 years of age with no infectious symptoms, interaction with the health care system, or antimicrobial use in the past 14 days and no history of immunosuppression.",[13],[22,27,31,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"PROCEDURE","Phelebotomy","Collection of 10mL of heparin anticoagulated blood, 10mL of EDTA anticoagulated blood, and 3mL of blood in a PAX gene tube",[9,18],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Broncheoalveolar Lavage","Bronchioalveolar lavage fluid (BALF) samples will be obtained from participants who are mechanically ventilated, and a bronchoscopy is indicated as part of routine clinical care. The BALF will be collected by a qualified ICU physician using standard clinical practice. Briefly, patients will receive appropriate sedation and analgesia, a flexible video-bronchoscope will be inserted into the patient's airway, and bronchial segments will be identified. The bronchoscope will be wedged in the most appropriate lung segment and 40-100mL of sterile normal saline (NS) as clinically indicated, will be injected into the bronchoscope port with using a 50mL syringe. Next, the instilled NS (i.e.: lavage fluid) will be collected in a sterile container using gentle suction. The BALF will then be partitioned and sent to clinical laboratories, and the remaining BALF (10-20mL) will be used in the ESTABLISH research study.",[9],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"Tracheal Aspirate","Tracheal Aspirate (TA) will be obtained from participants who have an endotracheal tube or a tracheostomy in situ at the time of ICU admission through out the ICU admission on the study days, as long as distal airway access is available.",[9],{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"Rectal Swab","A Rectal will be obtained at the time of ICU admission and on all study days during the ICU admission",[9],[40],{"name":41,"affiliation":42,"role":43},"Aleks Leligdowicz, MD PhD","Western University","PRINCIPAL_INVESTIGATOR",[45],{"name":41,"role":46,"phone":47,"phoneExt":48,"email":49},"CONTACT","519-661-2111","87241","aleligdo@uwo.ca",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Aleks Leligdowicz","RECRUITING","London","Ontario","N6A 3K7","Canada","CA",{"type":60,"coordinates":61},"Point",[62,63],-81.23304,42.98339,{"lat":63,"lon":62},[66],{"name":41,"role":46,"phone":47,"phoneExt":48,"email":67},"aleks.leligdowicz@lhsc.on.ca",{"type":43,"investigatorFullName":52,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Clinician Scientist",[71,73,75],{"name":72,"class":6},"London Health Sciences Centre",{"name":74,"class":6},"Western University, Canada",{"name":42,"class":6},"100484735","early-severe-illness-translational-biology-informatics-in-humans-100484735",false,"NCT05591924","Early Severe Illness TrAnslational BioLogy InformaticS in Humans","Prospective Observational Study of Biology of Critical Illness","Inclusion Criteria:\n\n* Age ≥18 years old\n* ≤48h since ICU admission\n* ICU admission within 72h of presentation to the emergency department (ER)\n* Clinical critical illness suspected on the basis of any one of the following:\n\n  1. Altered mental status (GCS\\\u003C15)\n  2. Cardiovascular collapse (presence of any: Heart rate \\>90, systolic blood pressure \\\u003C90, presence of vasopressors, lactate \\>2.0)\n  3. Respiratory collapse (presence of any: respiratory rate \\>20, PaCO₂ \\\u003C32 mm Hg, supplemental oxygen, invasive or non-invasive ventilation)\n  4. Suspected severe infection (presence of any: temperature \\>38°C or \\\u003C36°C, white blood cell (WBC) count \\>12,000\u002Fmm³ or \\\u003C4,000\u002Fmm³, presence of 1 or more antibiotics at the time of ICU admission)\n\nExclusion Criteria:\n\n* Age \\\u003C18 years old\n* \\>72h since ICU admission\n* Admission to ICU in patients \\>72h after the presentation to the ER\n* No evidence of critical illness (ICU admission due to bed-spacing)",true,"ALL","18 Years",{"count":87,"type":88},1000,"ESTIMATED","24 Months","OBSERVATIONAL","Advanced stages of the response to life-threatening infection, severe trauma, or other physiological insults often lead to exhaustion of the homeostatic mechanisms that sustain normal blood pressure and oxygenation. These syndromic presentations often meet the diagnostic criteria of sepsis and\u002For the acute respiratory distress syndrome (ARDS), the two most common syndromes encountered in the intensive care unit (ICU). Although critical illness syndromes, such as sepsis and ARDS, have separate clinical definitions, they often overlap clinically and share several common injury mechanisms. Moreover, there are no specific therapies for critically ill patients, and as a consequence, approximately 1 in 4 patients admitted to the ICU will not survive.\n\nThe purpose of this observational study is to identify early patient biologic factors that are present at the time of ICU admission that will help diagnose critical illness syndromes earlier, identify who could benefit most from specific therapies, and enable the discovery of new treatments for syndromes such as sepsis and ARDS.",[93,94,95,96,97,98,99,100,101],"Sepsis","ARDS","Critical Illness","Neurocognitive Dysfunction","Shock, Septic","Ventilator Associated Pneumonia","Immune Suppression","Inflammation","SIRS",[103,93,94,100,104,105,106,107],"Critical Care","Immune responses","Neurocognition","Critical illness","Translational Biology","2025-10-01",{"date":110,"type":111},"2025-10-06","ACTUAL",{"date":113,"type":111},"2024-04-26",{"date":115,"type":88},"2034-12-31",{"name":5,"class":6},1]