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| ID | Type | Description | Link |
|---|---|---|---|
| 7R35GM142710-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | One additional blood draw in the Emergency Department as part of their standard of care visit. |
| 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. |
| 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 |
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Inclusion Criteria:
• Patients who've developed a shocked state (Hypotension or Lactate grade >4) or Clinical Concern
Exclusion Criteria:
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Patients who've developed a shocked state or clinical concern that are going thru the Emergency Department.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Derek E Vanmeter | Contact | 507-255-4732 | Vanmeter.Derek@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Aadel A Chaudhuri, M.D., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Blood plasma, peripheral blood leukocytes, cfDNA
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |