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REMISE Study: REMnant Biospecimen Investigation in SEpsis

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT05684133
Collaborator
Vanderbilt University (Other), National Institute of General Medical Sciences (NIGMS) (NIH)
225
Enrollment
1
Location
26.2
Anticipated Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    225 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    REMISE Study: REMnant Biospecimen Investigation in SEpsis
    Actual Study Start Date :
    Oct 25, 2022
    Anticipated Primary Completion Date :
    Dec 30, 2024
    Anticipated Study Completion Date :
    Dec 30, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with Sepsis

    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.

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Measurement of traditional biomarkers in all samples [1/2024]

      Traditional biomarkers to be measured in remnant and research specimens including inflammatory and endothelial-related biomarkers.

    2. Measurement of proteomics in all samples [1/2024]

      Proteomics to be measured in remnant and research specimens to capture over 50 different plasma proteins.

    3. Measurement of metabolomics/lipidomics in all samples [1/2024]

      Metabolomics and lipidomics to be measured in remnant and research specimens to capture organic acids, amino acids, and phospholipids.

    4. Pathogen sequencing in all samples [1/2024]

      Pathogen sequencing will be performed on all remnant and research specimens to precisely identify the causative strain(s) in the infection.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • University of Pittsburgh
    • Vanderbilt University
    • National Institute of General Medical Sciences (NIGMS)

    Investigators

    • Principal Investigator: Christopher Seymour, M.D., University of Pittsburgh / UPMC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christopher Seymour, Associate Professor, Dept. of Critical Care Medicine, University of Pittsburgh School of Medicine Associate Professor, Depts. of Emergency Medicine & Clinical Translational Science The CRISMA Center, Director, Translational and Clinical Science Program, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT05684133
    Other Study ID Numbers:
    • STUDY21120013
    • 5R21GM144851-02
    First Posted:
    Jan 13, 2023
    Last Update Posted:
    Jan 13, 2023
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of Jan 13, 2023