REMISE Study: REMnant Biospecimen Investigation in SEpsis

Study Overview
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Brief Summary
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In the REMISE is study, we will compare blood proteins, biomarkers, and other -omics prospectively collected from patients with sepsis from two sources, i.) remnant (discarded) samples from the clinical laboratory, and ii.) prospectively collected in UPMC Presbyterian hospital research coordinator specimen collected biospecimens. Analyses will include traditional biomarkers, quantitative proteomics, metabolomics, lipidomics, transcriptomics, and pathogen genomic sequencing in both sets of samples. This data will allow the assessment of the feasibility, integrity, and scientific value of remnant samples compared to research coordinator samples collected at the bedside for mechanistic sepsis research.

Official Title
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REMISE Study: REMnant Biospecimen Investigation in SEpsis

Conditions
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Sepsis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient, at least 18 years of age Meeting Sepsis-3 criteria within 6 hours of admission Biospecimens obtained for routine clinical care and measurement Peripheral intravenous access Exclusion Criteria: Patients who do not have Sepsis-3 Traumatic injury, Inability to consent or contact legal representative, Cardiac arrest, Stroke, Comfort measures only, Unable to obtain intravenous access, and/or Subject declines to participate. No residual blood left in clinical sample

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Sepsis<br>Adult patients (18 years or older) meeting Sepsis-3 criteria within 6 hours of emergency department admission. Patients will be excluded with the following conditions: traumatic injury, cardiac arrest, stroke, comfort measures only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in traditional biomarkers, proteomics, pathogen sequencing, and metabolomics/lipidomics between prospectively collected biospecimens and remnant biospecimens. |  | 01/2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of traditional biomarkers in all samples | Traditional biomarkers to be measured in remnant and research specimens including inflammatory and endothelial-related biomarkers. | 1/2024 | 
| Measurement of proteomics in all samples | Proteomics to be measured in remnant and research specimens to capture over 50 different plasma proteins. | 1/2024 | 
| Measurement of metabolomics/lipidomics in all samples | Metabolomics and lipidomics to be measured in remnant and research specimens to capture organic acids, amino acids, and phospholipids. | 1/2024 | 
| Pathogen sequencing in all samples | Pathogen sequencing will be performed on all remnant and research specimens to precisely identify the causative strain(s) in the infection. | 1/2024 |