Dynamics of Organ Damage and Immune Exhaustion During Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation.
- Who it may be relevant to
- Registry conditions: Sepsis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cell-free DNA Epigenomics to Track the Dynamics of Organ Damage and Immune Exhaustion During Sepsis
Overview
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.
Interventions
- Other Observation
One additional blood draw in the Emergency Department as part of their standard of care visit.
Primary outcome measures
- 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.]
Secondary outcome measures (4)
- ICU Time [Time frame: Up to 1 year after patient enrollment date]
- Hospital Stay Duration [Time frame: Up to 1 year after patient enrollment date]
- Renal Replacement Therapy [Time frame: Up to 1 year after patient enrollment date]
- Ventilator and Vasopressor Free Days [Time frame: Up to 1 year after patient enrollment date]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic Rochester — Rochester
Identifiers
NCT: NCT06817408 · 24-009707 · 7R35GM142710-04