REMISE Study: REMnant Biospecimen Investigation in SEpsis

Completed

• Conditions: Sepsis

• Registration Number: NCT05684133
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-25
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-13
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
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.
Measurement of proteomics in all samples	1/2024	Proteomics to be measured in remnant and research specimens to capture over 50 different plasma proteins.
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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States