RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. A 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.

Official Title

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

Quick Facts

Study Start:2023-08-23
Study Completion:2026-08-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05758246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>=65 years
  2. * Primary diagnosis of acute infection (per investigator judgment)
  3. * SOFA \>1
  4. * Admission order to the hospital
  5. * Expected length of stay \>=48 hours (per investigator judgment)
  1. * Admission to the ICU
  2. * Vasopressors, mechanical ventilation, or dialysis
  3. * Comfort care only
  4. * Total bilirubin \>3X or AST/ALT \>4x upper limit of normal
  5. * eGFR \< 25 ml/ min/ 1.73 m2
  6. * Hemoglobin \<7 g/dL; white blood cell count ≤ 2,000/mm3; absolute neutrophil count ≤1 x 10\^9/;, or platelet count ≤ 40,000/μL
  7. * Known HIV, Hepatitis B, or Hepatitis C
  8. * Invasive fungal infection (per investigator judgment)
  9. * Uncontrolled effusions or ascites (per investigator judgment)
  10. * New/active invasive cancer except non-melanoma skin cancers
  11. * Known hypersensitivity or allergy to Fisetin.
  12. * Active treatment with potential drug-drug interactions
  13. * Enrolled in another sepsis clinical trial

Contacts and Locations

Study Contact

Michael Puskarich, MD
CONTACT
612 626 6911
mike-em@umn.edu

Principal Investigator

Michael Puskarich, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

Ridges
Burnsville, Minnesota, 55337
United States
Southdale
Edina, Minnesota, 55435
United States
M Health Fairview St. John's
Maplewood, Minnesota, 55109
United States
St. John's
Maplewood, Minnesota, 55109
United States
University of Minnesota
Minneapolis, Minnesota, 55414
United States
HCMC
Minneapolis, Minnesota, 55415
United States
UMMC
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Michael Puskarich, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-23
Study Completion Date2026-08-23

Study Record Updates

Study Start Date2023-08-23
Study Completion Date2026-08-23

Terms related to this study

Additional Relevant MeSH Terms

  • Sepsis
  • Acute Infection
  • Organ Failure