REMISE Study: REMnant Biospecimen Investigation in SEpsis

NCT05684133 | Completed

• 2 other identifiers: STUDY211200135R21GM144851-02
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Difference in traditional biomarkers, proteomics, pathogen sequencing, and metabolomics/lipidomics between prospectively collected biospecimens and remnant biospecimens.

  01/2024

Secondary Outcomes (4)

• Measurement of traditional biomarkers in all samples

  1/2024

• Measurement of proteomics in all samples

  1/2024

• Measurement of metabolomics/lipidomics in all samples

  1/2024

• Pathogen sequencing in all samples

  1/2024

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Sepsis-3 presenting to eligible emergency departments.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Remnant/leftover blood samples collected after usual patient care in comparison to newly obtained blood samples to evaluate 1) validity and stability of remnant blood samples vs fresh, newly obtained blood samples. 2) blood proteins, biomarkers, and other -omics

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Seymour, M.D.

  University of Pittsburgh / UPMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: October 25, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)