Sepsis
Conditions
Keywords
Sepsis
Brief 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.
Interventions
OTHERObservation
One additional blood draw in the Emergency Department as part of their standard of care visit.
Sponsors
Mayo Clinic
National Institute of General Medical Sciences (NIGMS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient 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. | Overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Time | Up to 1 year after patient enrollment date | Time for patient in ICU |
| Hospital Stay Duration | Up to 1 year after patient enrollment date | Days |
| Renal Replacement Therapy | Up to 1 year after patient enrollment date | If patient needed renal replacement therapy during duration on study. |
| Ventilator and Vasopressor Free Days | Up to 1 year after patient enrollment date | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAadel A Chaudhuri, M.D., Ph.D.
Mayo Clinic
Outcome results
None listed