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NCT05684133 Clinical Trial

REMISE Study: REMnant Biospecimen Investigation in SEpsis

Sepsis Clinical Trial

— REMISE  

Official title:
REMISE Study: REMnant Biospecimen Investigation in SEpsis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05684133
Other study ID # STUDY21120013
Secondary ID 5R21GM144851-02
Status Completed
Phase
First received
Last updated
Start date October 25, 2022
Est. completion date December 31, 2023

Study information
Verified date February 2024
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (3)
Lead Sponsor Collaborator
University of Pittsburgh National Institute of General Medical Sciences (NIGMS), Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in traditional biomarkers, proteomics, pathogen sequencing, and metabolomics/lipidomics between prospectively collected biospecimens and remnant biospecimens. 01/2024
Secondary 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
Secondary Measurement of proteomics in all samples Proteomics to be measured in remnant and research specimens to capture over 50 different plasma proteins. 1/2024
Secondary 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
Secondary 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
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