Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial

Launched by UNIVERSITY OF MINNESOTA · Feb 24, 2023

Keywords

ClinConnect Summary

The STOP-Sepsis Trial is studying a potential new treatment for older patients who have sepsis, a serious condition caused by an infection that can lead to organ failure. Researchers are testing a medication called fisetin, which may help reduce the severity of sepsis by targeting specific cells in the body that can worsen the condition. The goal is to find out the best dose of fisetin to improve heart, lung, and kidney function within a week of treatment.

To participate in this trial, you need to be at least 65 years old and have a primary diagnosis of an acute infection, which means a sudden and severe infection. You should also have a certain level of organ dysfunction, based on a scoring system used by doctors. However, if you are in intensive care, on life support, or have certain serious health conditions, you may not be eligible to join the study. If you qualify and decide to participate, you will receive treatment and be monitored closely to see how well it works. This study is an important step toward finding better ways to treat sepsis in older adults.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• 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