NCT06817408

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Sepsis

Interventions

Type	Name	Description
OTHER	Observation	One additional blood draw in the Emergency Department as part of their standard of care visit.

Timeline

• Start date: 2025-03-25
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2025-02-10
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States