[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05758246":3,"trial-entities:NCT05758246":222,"trial-summary:NCT05758246":227},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":45,"secondary_outcomes":50,"sex":83,"minimum_age":84,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":85,"std_ages":107,"locations":109,"central_contacts":208,"overall_officials":213,"references":216,"see_also_links":221},"NCT05758246","HRP-XXX","Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial","RECRUITING","2026-08-23","2025-10","2025-10-15","2023-08-23","University of Minnesota","OTHER",false,"The long-term goal is to test the clinical efficacy of senolytic therapies to reduce progression to and severity of sepsis in older patients. The central hypothesis is that a threshold burden of SnCs predisposes to a SASP mediated dysfunctional response to PAMPs, contributing to a disproportionate burden of sepsis in older patients. The study hypothesizes timely treatment with fisetin will interrupt this pathway.\n\nA multicenter, randomized, adaptive allocation clinical trial to identify the most efficacious dose of the senolytic fisetin to reduce the composite cardiovascular, respiratory, and renal sequential organ failure assessment score at 1 week, and predict the probability of success of a definitive phase III clinical trial.",null,[18,19,20],"Sepsis","Acute Infection","Organ Failure",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},220,"ESTIMATED",[30,36,41],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Fisetin-dose 1","20mg\u002Fkg once a day for one day.",[35],"Fisetin- dose 1",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Fisetin-dose 2","20mg\u002Fkg once a day for two days",[40],"Fisetin- dose 2",{"type":31,"name":42,"description":43,"armGroupLabels":44},"Placebo","Placebo treatment",[42],[46],{"measure":47,"description":48,"timeFrame":49},"Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA)","The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure\u002Fhemodynamics) and assigns a score based on the data obtained in each category. This outcome assesses only the cardiovascular, respiratory, and renal categories of the total SOFA score, and calculates the change from day 0 to day 7.","day 7",[51,55,58,61,64,67,68,69,72,76,79,80],{"measure":52,"description":53,"timeFrame":54},"Safety of 2 doses of fisetin in patients with mild sepsis","Outcome is the number of serious adverse event","day 28",{"measure":56,"description":57,"timeFrame":54},"Organ failure free days","Outcome is 28 days minus the last day the patient required any of the following: ventilator support, vasopressors, or dialysis \u002F renal replacement therapy. Patients who die prior to day 28 are given a value of -1.",{"measure":59,"description":60,"timeFrame":49},"Total SOFA score","The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure\u002Fhemodynamics) and assigns a score based on the data obtained in each category.",{"measure":62,"description":63,"timeFrame":49},"Zubrod performance status","A scale for indicating a patient's functional level: 0 asymptomatic - 1 Symptomatic, fully ambulatory - 2 Symptomatic, in bed - 50% of the day - 3 Symptomatic, in bed; 50% of the day but not bedridden - 4 Bedridden - 5 Dead.",{"measure":65,"description":66,"timeFrame":49},"SF-12 score","The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual 39;s everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher.",{"measure":65,"description":66,"timeFrame":54},{"measure":62,"description":63,"timeFrame":54},{"measure":70,"description":71,"timeFrame":54},"Days in the ICU","This outcome is the number of days the patient was admitted to the ICU.",{"measure":73,"description":74,"timeFrame":75},"All-cause mortality","This outcome is the proportion of patients suffering all-cause mortality prior to day 28.","Day 28",{"measure":77,"description":78,"timeFrame":49},"Peripheral CD3+ senescent (SnCs) immune cells","Outcome is the relative expression of p16Ink4a in CD3+ cells.",{"measure":78,"description":78,"timeFrame":54},{"measure":81,"description":82,"timeFrame":49},"TNF-alpha","Outcome is the concentration of TNF-alpha by Luminex human discovery assay","ALL","65 Years",{"inclusion":86,"exclusion":92,"raw_text":106},[87,88,89,90,91],"Age \\>=65 years","Primary diagnosis of acute infection (per investigator judgment)","SOFA \\>1","Admission order to the hospital","Expected length of stay \\>=48 hours (per investigator judgment)",[93,94,95,96,97,98,99,100,101,102,103,104,105],"Admission to the ICU","Vasopressors, mechanical ventilation, or dialysis","Comfort care only","Total bilirubin \\>3X or AST\u002FALT \\>4x upper limit of normal","eGFR \\\u003C 25 ml\u002F min\u002F 1.73 m2","Hemoglobin \\\u003C7 g\u002FdL; white blood cell count ≤ 2,000\u002Fmm3; absolute neutrophil count ≤1 x 10\\^9\u002F;, or platelet count ≤ 40,000\u002FμL","Known HIV, Hepatitis B, or Hepatitis C","Invasive fungal infection (per investigator judgment)","Uncontrolled effusions or ascites (per investigator judgment)","New\u002Factive invasive cancer except non-melanoma skin cancers","Known hypersensitivity or allergy to Fisetin.","Active treatment with potential drug-drug interactions","Enrolled in another sepsis clinical trial","Inclusion Criteria:\n\n* Age \\>=65 years\n* Primary diagnosis of acute infection (per investigator judgment)\n* SOFA \\>1\n* Admission order to the hospital\n* Expected length of stay \\>=48 hours (per investigator judgment)\n\nExclusion Criteria:\n\n* Admission to the ICU\n* Vasopressors, mechanical ventilation, or dialysis\n* Comfort care only\n* Total bilirubin \\>3X or AST\u002FALT \\>4x upper limit of normal\n* eGFR \\\u003C 25 ml\u002F min\u002F 1.73 m2\n* Hemoglobin \\\u003C7 g\u002FdL; white blood cell count ≤ 2,000\u002Fmm3; absolute neutrophil count ≤1 x 10\\^9\u002F;, or platelet count ≤ 40,000\u002FμL\n* Known HIV, Hepatitis B, or Hepatitis C\n* Invasive fungal infection (per investigator judgment)\n* Uncontrolled effusions or ascites (per investigator judgment)\n* New\u002Factive invasive cancer except non-melanoma skin cancers\n* Known hypersensitivity or allergy to Fisetin.\n* Active treatment with potential drug-drug interactions\n* Enrolled in another sepsis clinical trial",[108],"OLDER_ADULT",[110,125,138,150,159,169,174,180,188,195],{"facility":111,"status":7,"city":112,"state":113,"zip":114,"country":115,"contacts":116,"geoPoint":122},"University of Florida","Gainesville","Florida","32608","United States",[117],{"name":118,"role":119,"phone":120,"email":121},"Faheem W Guirgis, MD","CONTACT","352-265-5911","fguirgis@ufl.edu",{"lat":123,"lon":124},29.65163,-82.32483,{"facility":126,"status":7,"city":127,"state":128,"zip":129,"country":115,"contacts":130,"geoPoint":135},"University of Iowa","Iowa City","Iowa","52242",[131],{"name":132,"role":119,"phone":133,"email":134},"Brett A Faine, PharmD","319-310-8067","brett-faine@uiowa.edu",{"lat":136,"lon":137},41.66113,-91.53017,{"facility":139,"status":7,"city":140,"state":141,"zip":142,"country":115,"contacts":143,"geoPoint":147},"Ridges","Burnsville","Minnesota","55337",[144],{"name":145,"role":119,"email":146},"Lauren Barrett","barre998@umn.edu",{"lat":148,"lon":149},44.76774,-93.27772,{"facility":151,"status":7,"city":152,"state":141,"zip":153,"country":115,"contacts":154,"geoPoint":156},"Southdale","Edina","55435",[155],{"name":145,"role":119,"email":146},{"lat":157,"lon":158},44.88969,-93.34995,{"facility":160,"status":7,"city":161,"state":141,"zip":162,"country":115,"contacts":163,"geoPoint":166},"M Health Fairview St. John's","Maplewood","55109",[164],{"name":165,"role":119},"David Wacker, PhD",{"lat":167,"lon":168},44.95302,-92.99522,{"facility":170,"status":7,"city":161,"state":141,"zip":162,"country":115,"contacts":171,"geoPoint":173},"St. John's",[172],{"name":145,"role":119,"email":146},{"lat":167,"lon":168},{"facility":12,"status":7,"city":175,"state":141,"zip":176,"country":115,"geoPoint":177},"Minneapolis","55414",{"lat":178,"lon":179},44.97997,-93.26384,{"facility":181,"status":7,"city":175,"state":141,"zip":182,"country":115,"contacts":183,"geoPoint":187},"HCMC","55415",[184],{"name":185,"role":119,"email":186},"Audrey Hendrickson","Audrey.Hendrickson@hcmed.org",{"lat":178,"lon":179},{"facility":189,"status":7,"city":175,"state":141,"zip":190,"country":115,"contacts":191,"geoPoint":194},"UMMC","55455",[192],{"name":193,"role":119,"email":146},"Lauryn Barrett",{"lat":178,"lon":179},{"facility":196,"status":7,"city":197,"state":198,"zip":199,"country":115,"contacts":200,"geoPoint":205},"University of Mississippi Medical Center","Jackson","Mississippi","39216",[201],{"name":202,"role":119,"phone":203,"email":204},"James W Galbraith, MD","601-984-5443","jgalbraith@umc.edu",{"lat":206,"lon":207},32.29876,-90.18481,[209],{"name":210,"role":119,"phone":211,"email":212},"Michael Puskarich, MD","612 626 6911","mike-em@umn.edu",[214],{"name":210,"affiliation":12,"role":215},"PRINCIPAL_INVESTIGATOR",[217],{"pmid":218,"type":219,"citation":220},"39434114","DERIVED","Silva M, Wacker DA, Driver BE, Staugaitis A, Niedernhofer LJ, Schmidt EL, Kirkland JL, Tchkonia T, Evans T, Serrano CH, Ventz S, Koopmeiners JS, Puskarich MA; STOP-Sepsis Investigators. Senolytics To slOw Progression of Sepsis (STOP-Sepsis) in elderly patients: Study protocol for a multicenter, randomized, adaptive allocation clinical trial. Trials. 2024 Oct 21;25(1):698. doi: 10.1186\u002Fs13063-024-08474-2.",[],{"nct_id":4,"conditions":223,"biomarkers":226},[224,20,225],"Acute infectious disease","Septicemia",[],{"nct_id":4,"found":228,"summary":229,"prompt_version":239},true,{"design":230,"status":231,"heading":232,"summary":233,"follow_up":234,"word_count":235,"commitments":236,"compensation":237,"drugs_mentioned":238},"This is a multicenter, randomized study, meaning participants are assigned by chance to receive Fisetin or a placebo. It plans to enroll 220 participants.","completed","STOP-Sepsis Trial: Fisetin for Sepsis in Older Adults","This study, called STOP-Sepsis, is testing if a drug called Fisetin can help older adults (age 65 and up) with acute infections and early signs of organ failure. Sepsis is a serious condition where the body's response to an infection damages its own tissues and organs. Researchers believe Fisetin might interrupt a specific pathway that contributes to sepsis in older patients. You would receive either Fisetin (one or two doses) or a placebo (an inactive substance). The main goal is to see if Fisetin can reduce the severity of organ damage (heart, lungs, kidneys) after one week. The study is currently recruiting 220 participants.","The main outcome is measured at day 7, which suggests follow-up for at least one week after treatment.",104,"Not specified in the trial record.","Not stated in the trial record.",[42],"v2"]