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NCT Number: NCT06817408

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Aadel A Chaudhuri, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Derek E Vanmeter

CONTACT

[email protected]

507-255-4732

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

One additional blood draw in the Emergency Department as part of their standard of care visit.

Primary outcomes

  1. Patient Survival

    Time frame: From date of patient enrollment until date of death for any cause or up to 1 year after patient enrollment date, whichever comes first.

    Overall survival

Secondary outcomes

  1. ICU Time

    Time frame: Up to 1 year after patient enrollment date

    Time for patient in ICU

  2. Hospital Stay Duration

    Time frame: Up to 1 year after patient enrollment date

    Days

  3. Renal Replacement Therapy

    Time frame: Up to 1 year after patient enrollment date

    If patient needed renal replacement therapy during duration on study.

  4. Ventilator and Vasopressor Free Days

    Time frame: Up to 1 year after patient enrollment date

Study contacts

Contact information is provided by the study sponsor or research team.

Derek E Vanmeter

CONTACT

[email protected]

507-255-4732

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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