REMISE Study: REMnant Biospecimen Investigation in SEpsis (REMISE)

February 27, 2024 updated by: Christopher Seymour, University of Pittsburgh

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in traditional biomarkers, proteomics, pathogen sequencing, and metabolomics/lipidomics between prospectively collected biospecimens and remnant biospecimens.
Time Frame: 01/2024
01/2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1/2024
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.
1/2024
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.
1/2024
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.
1/2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Vanderbilt University
National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: Christopher Seymour, M.D., University of Pittsburgh / UPMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY21120013
  • 5R21GM144851-02 (U.S. NIH Grant/Contract: NIH/NIGMS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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