[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06809868":3,"trial-entities:NCT06809868":113,"trial-summary:NCT06809868":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":26,"study_type":32,"primary_purpose":16,"phases":33,"enrollment_info":34,"interventions":37,"primary_outcomes":45,"secondary_outcomes":48,"sex":54,"minimum_age":55,"maximum_age":16,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":71,"locations":74,"central_contacts":104,"overall_officials":107,"references":111,"see_also_links":112},"NCT06809868","23-39420","Role of Transposable Elements in Septic Immune Aging","RECRUITING","2028-08-14","2026-01","2026-01-30","2025-02-14","University of California, San Francisco","OTHER",false,"The goal of this observational study is to learn about how transposable element levels affect the patient outcomes in sepsis. The main questions it aims to answer is:\n\n1. Do transposable elements prematurely age the immune systems of patients with sepsis?\n2. Do transposable elements correlate with increased mortality in patients with sepsis in the ICU?\n3. Do transposable elements correlate with increased amount of secondary infections in patients with sepsis in the ICU?\n\nParticipants will have blood drawn from them but will not be subjected to additional interventions.",null,[18,19,20,21,22,23,24,25],"Sepsis","Sepsis and Septic Shock","Sepsis With Multiple Organ Dysfunction (MOD)","Sepsis With Acute Organ Dysfunction","Sepsis, Severe","Sepsis at Intensive Care Unit","Sepsis, Severe Sepsis and Septic Shock","Sepsis, Septic Shock",[18,27,28,29,30,31],"Transposable Elements","Immune Aging","Mortality","Secondary Infections","Critical Care Medicine (ICU)","OBSERVATIONAL",[],{"count":35,"type":36},116,"ESTIMATED",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42},"GENETIC","RNA and DNA Sequencing","DNA and RNA sequencing will be conducted on both control participants and patients with sepsis who are admitted to the ICU.",[43,44],"Healthy Individual Controls","Patients with Sepsis",[46],{"measure":28,"timeFrame":47},"6 weeks",[49,52],{"measure":50,"timeFrame":51},"Mortality (30-day)","30 days",{"measure":53,"timeFrame":51},"Secondary Infection","ALL","18 Years",true,{"inclusion":58,"exclusion":62,"raw_text":70},[59,60,61],"Age 18 or older","Admitted to ICU with sepsis (Sepsis 3 Criteria)","SOFA score of at least 2 at time of enrollment",[63,64,65,66,67,68,69],"Patients on organ transplantation immunosuppression","Patients with preexisting leukopenia","Cancer patients receiving CAR-T therapy","Patients who are under 18 years of age or otherwise deemed pediatric","Patients with an ongoing bleeding diathesis (ie: DIC, hemorrhagic shock)","Patients with a chronic hemoglobin below 7.0","Patients who, prior to their ICU admission, are blood transfusion dependent","Inclusion Criteria:\n\n* Age 18 or older\n* Admitted to ICU with sepsis (Sepsis 3 Criteria)\n* SOFA score of at least 2 at time of enrollment\n\nExclusion Criteria:\n\n* Patients on organ transplantation immunosuppression\n* Patients with preexisting leukopenia\n* Cancer patients receiving CAR-T therapy\n* Patients who are under 18 years of age or otherwise deemed pediatric\n* Patients with an ongoing bleeding diathesis (ie: DIC, hemorrhagic shock)\n* Patients with a chronic hemoglobin below 7.0\n* Patients who, prior to their ICU admission, are blood transfusion dependent",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":12,"status":7,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":101},"San Francisco","California","94143","United States",[81,86,89,91,93,94,97,99],{"name":82,"role":83,"phone":84,"email":85},"Alexendar R Perez, M.D., Ph.D","CONTACT","415-476-1000","Alexendar.Perez@ucsf.edu",{"name":87,"role":83,"phone":84,"email":88},"Matthieu Legrand, M.D., Ph.D","matthieu.legrand@ucsf.edu",{"name":82,"role":90},"PRINCIPAL_INVESTIGATOR",{"name":92,"role":90},"Judith Hellman, M.D.",{"name":87,"role":90},{"name":95,"role":96},"Elizabeth Whitlock, M.D.","SUB_INVESTIGATOR",{"name":98,"role":96},"Orestes Mavrothalassitis, M.D.",{"name":100,"role":96},"Joana Vidigal, Ph.D",{"lat":102,"lon":103},37.77493,-122.41942,[105,106],{"name":82,"role":83,"phone":84,"email":85},{"name":87,"role":83,"phone":84,"email":88},[108,109,110],{"name":82,"affiliation":12,"role":90},{"name":92,"affiliation":12,"role":90},{"name":87,"affiliation":12,"role":90},[],[],{"nct_id":4,"conditions":114,"biomarkers":116},[115],"Septicemia",[],{"nct_id":4,"found":56,"summary":118,"prompt_version":128},{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is an observational study, meaning participants will be monitored without receiving new treatments. It plans to enroll 116 participants.","completed","Observational Study on Transposable Elements in Sepsis","This study is looking at how 'transposable elements' (pieces of DNA that can move around in our genes) might affect people with sepsis. Researchers want to see if these elements make the immune system age faster, increase the risk of death, or lead to more infections in patients with sepsis in the ICU (Intensive Care Unit). You could join if you are 18 or older and admitted to the ICU with sepsis. The study will measure 'immune aging' (how old your immune system appears) at 6 weeks. The current recruitment status is unclear.","Immune aging will be measured at 6 weeks.",93,"Participants will have blood drawn but will not undergo any additional procedures or interventions.","Not stated in the trial record.",[],"v2"]