Dynamics of Organ Damage and Immune Exhaustion During Sepsis

Cell-free DNA Epigenomics to Track the Dynamics of Organ Damage and Immune Exhaustion During Sepsis

This is a prospective, non-randomized study investigating if organ damage and immune changes can be measured by liquid biopsy NGS through advanced analytical methods.

Study Overview

• Status: Active, not recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: Observation

Detailed Description

To determine the sample size needed to derive a signature matrix to identify novel biomarkers in sepsis, investigators performed a mathematical modeling exercise of the lower limits of sensitivity of this liquid biopsy approach. The detection limit of cell-free nucleic acid analysis is determined in part by the number of independent transcripts or "reporters" that are interrogated. Using an established and independently validated binomial model that was previously applied to the prediction of circulating tumor nucleic acid detection limits, investigators estimated the probability of cell-free nucleic acid detection in sepsis patients based on the number of unique tissue-specific reporters (i.e., hepatic transcripts that may reflect disease severity). This yields a result of n=18 per group to achieve 0.90 power at alpha=0.05. The investigators will thus plan to analyze data from n=18 per cell/tissue type to derive the signature matrix for this project.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who've developed a shocked state or clinical concern that are going thru the Emergency Department.

Description

Inclusion Criteria:

• Patients who've developed a shocked state (Hypotension or Lactate grade >4) or Clinical Concern

Exclusion Criteria:

• <18 years of age
• Pregnant Women
• Nursing women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Survival	Overall survival	From date of patient enrollment until date of death for any cause or up to 1 year after patient enrollment date, whichever comes first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Time	Time for patient in ICU	Up to 1 year after patient enrollment date
Hospital Stay Duration	Days	Up to 1 year after patient enrollment date
Renal Replacement Therapy	If patient needed renal replacement therapy during duration on study.	Up to 1 year after patient enrollment date
Ventilator and Vasopressor Free Days		Up to 1 year after patient enrollment date

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Aadel A Chaudhuri, M.D., Ph.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: 24-009707; 7R35GM142710-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No