[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100447784":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":25,"centralContacts":33,"locations":43,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":10,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":10,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Sepsis",null,"Blood collection: Blood will be collected from patient at day 4, day 7, day 14-21 and at 3 and 6 months.",[13],"Other: Blood sampling",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy Controls","Blood Collection.\n\nThe healthy volunteer participants will donate a blood sample. These controls will allow the investigators to determine if the values obtained are accurate, reliable, and repeatable.",[13],{"label":19,"type":10,"description":11,"interventionNames":20},"Trauma",[13],[22],{"type":6,"name":23,"description":23,"armGroupLabels":24,"otherNames":10},"Blood sampling",[15,9,19],[26,29,31],{"name":27,"affiliation":5,"role":28},"Lyle Moldawer, PhD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"Philip Efron, MD",{"name":32,"affiliation":5,"role":28},"Tyler Loftus, MD",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Jennifer Lanz, MSN","CONTACT","352-273-5497","jennifer.lanz@surgery.ufl.edu",{"name":40,"role":36,"phone":41,"phoneExt":10,"email":42},"Ruth Davis, BSN","352-273-5897","ruth.davis@surgery.ufl.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"UF Health at Shands hospital","RECRUITING","Gainesville","Florida","32610","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-82.32483,29.65163,{"lat":56,"lon":55},[59,60],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},{"name":40,"role":36,"phone":61,"phoneExt":10,"email":42},"325-273-5897",{"type":63,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[65],{"name":66,"class":67},"National Institute of General Medical Sciences (NIGMS)","NIH","100447784","dysfunctional-myelopoiesis-and-myeloid-derived-suppressor-cells-in-sepsis-100447784",false,"NCT05110937","Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis","Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology Subtitle: Pathological Myeloid Activation After Sepsis and Trauma","Sepsis participant:\n\nInclusion Criteria:\n\n1. age ≥18 years\n2. meets criteria for sepsis\u002Fseptic shock by Sepsis-3 consensus criteria.\n\nExclusion Criteria:\n\n1. have disease states that predispose to significant immune system dysfunction\n2. have comorbidity burden or goals of care that preclude recovery after sepsis. These criteria include:\n\n   a. irreversible shock (death \\\u003C12 hours) b. uncontrollable surgical source of sepsis c. patients deemed to be futile care or have advanced directives limiting resuscitative efforts d. alternative diagnoses causing shock state (e.g., hemorrhage, myocardial infarction or pulmonary embolus) e. known HIV infection with CD4+ count \\\u003C200 cells\u002Fmm3 g. severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to the intensive care unit.\n3. known pregnancy\n4. enrollment \\>96 hours after suspected sepsis onset\n5. pre-hospitalization bedridden performance status (WHO\u002FZubrod score ≥4)\n6. subsequent clinical adjudication diagnosis not consistent with sepsis\u002Fseptic shock by Sepsis-3 criteria.\n7. Burn injury greater than 20% total body surface area (tBSA)\n\nTrauma Participant:\n\nInclusion Criteria\n\n1. All adults age ≥ 18 years\n2. Blunt trauma patient with a. Injury Severity Score (ISS) greater than or equal to 25 b. ISS \\> 15 and one of the following: i. \\> 4 units of PRBC or \\>3 units of whole blood or \\>1500 ml of autogenous blood product in the first 24 hours of admission ii. AIS (acute injury score) \\> 2 spine iii. Shock on arrival (Systolic blood pressure (SBP) \\\u003C 90)\n\nOR\n\nc. ISS \\> 15 and two of the following: i. Age \\> 55 ii. AIS \\> 2 chest iii. +ETOH (ethyl alcohol) on arrival iv. Any red blood cell transfusion in first 24 hours\n\nExclusion Criteria\n\n1. Patients not expected to survive greater than 48 hours.\n2. Prisoners.\n3. Pregnancy.\n4. Previous bone marrow transplantation.\n5. Patients with End Stage Renal Disease.\n6. Patients with any pre-existing hematological disease.\n7. Patients deemed to be futile care or have advanced directives limiting resuscitative efforts.\n8. Known HIV infection with CD4+ count \\\u003C200 cells\u002Fmm3\n9. Burn injury greater than 20% tBSA",true,"ALL","18 Years","100 Years",{"count":80,"type":81},450,"ESTIMATED","OBSERVATIONAL","Adverse outcomes in surgical sepsis patients are secondary to dysregulated emergency myelopoiesis, and expansion of myeloid-derived suppressor cells. Here we propose to determine the underlying mechanisms behind the increased expansion of these leukocyte populations and the underlying mechanisms that drive inflammation and immune suppression.",[9,85],"Trauma Injury","2025-12-23",{"date":88,"type":89},"2025-12-26","ACTUAL",{"date":91,"type":89},"2022-01-04",{"date":93,"type":81},"2027-04",{"name":5,"class":6},1]