REMISE Study: REMnant Biospecimen Investigation in SEpsis

NCT ID: NCT05684133

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-25

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Seymour, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh / UPMC

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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5R21GM144851-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY21120013

Identifier Type: -

Identifier Source: org_study_id

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