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REMISE Study: REMnant Biospecimen Investigation in SEpsis

REMISE Study: REMnant Biospecimen Investigation in SEpsis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05684133
Acronym
REMISE
Enrollment
71
Registered
2023-01-13
Start date
2022-10-25
Completion date
2023-12-31
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Brief summary

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.

Interventions

None listed

Sponsors

Vanderbilt University
CollaboratorOTHER
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Difference in traditional biomarkers, proteomics, pathogen sequencing, and metabolomics/lipidomics between prospectively collected biospecimens and remnant biospecimens.01/2024

Secondary

MeasureTime frameDescription
Measurement of traditional biomarkers in all samples1/2024Traditional biomarkers to be measured in remnant and research specimens including inflammatory and endothelial-related biomarkers.
Measurement of proteomics in all samples1/2024Proteomics to be measured in remnant and research specimens to capture over 50 different plasma proteins.
Measurement of metabolomics/lipidomics in all samples1/2024Metabolomics and lipidomics to be measured in remnant and research specimens to capture organic acids, amino acids, and phospholipids.
Pathogen sequencing in all samples1/2024Pathogen sequencing will be performed on all remnant and research specimens to precisely identify the causative strain(s) in the infection.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026