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Completed

NCT Number: NCT05684133

REMISE Study: REMnant Biospecimen Investigation in SEpsis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 01/2024

Secondary outcomes

  1. Measurement of traditional biomarkers in all samples

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 1/2024

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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Acronym: REMISE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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