NCT05758246 · University of Minnesota
Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
What this study is about
The long-term goal is to test the clinical effectiveness 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.
View original scientific description
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.
Interventions
DRUG
Fisetin-dose 1
20mg/kg once a day for one day.
DRUG
Fisetin-dose 2
20mg/kg once a day for two days
DRUG
Placebo
Placebo treatment
Primary outcome measures
Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA)
Time frame: day 7
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/hemodynamics) 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age \>=65 years
- Primary diagnosis of acute infection (per investigator judgment)
- Admission order to the hospital
- Expected length of stay \>=48 hours (per investigator judgment)
Exclusion criteria
- Admission to the ICU
- Vasopressors, mechanical ventilation, or dialysis
- Comfort care only
- Total bilirubin \>3X or AST/ALT \>4x upper limit of normal
- eGFR \< 25 ml/ min/ 1.73 m2
- Hemoglobin \<7 g/dL; white blood cell count ≤ 2,000/mm3; absolute neutrophil count ≤1 x 10\^9/;, or platelet count ≤ 40,000/μL
- Known HIV, Hepatitis B, or Hepatitis C
- Invasive fungal infection (per investigator judgment)
- Uncontrolled effusions or ascites (per investigator judgment)
- New/active 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
Where
- Gainesville, Florida
- Iowa City, Iowa
- Burnsville, Minnesota
- Edina, Minnesota
- Maplewood, Minnesota
- Minneapolis, Minnesota
- Jackson, Mississippi
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2025 · Source of record for eligibility and locations