SepsisREMISENCT05684133
REMISE Study: REMnant Biospecimen Investigation in SEpsis
An observational study of Sepsis, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with Sepsis-3 presenting to eligible emergency departments.
Who may be able to join
- 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
Who cannot join
- Patients who do not have Sepsis-3
- Traumatic injury,
- Inability to consent or contact legal representative,
- Cardiac arrest,
- Stroke,
- Comfort measures only,
Show all 9Show fewer
- Unable to obtain intravenous access, and/or
- Subject declines to participate.
- No residual blood left in clinical sample
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Difference in traditional biomarkers, proteomics, pathogen sequencing, and metabolomics/lipidomics between prospectively collected biospecimens and remnant biospecimens.
Measured: 01/2024
Secondary outcomes (4)
Measurement of traditional biomarkers in all samples
Traditional biomarkers to be measured in remnant and research specimens including inflammatory and endothelial-related biomarkers.
Measured: 1/2024
Measurement of proteomics in all samples
Proteomics to be measured in remnant and research specimens to capture over 50 different plasma proteins.
Measured: 1/2024
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.
Measured: 1/2024
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.
Measured: 1/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start25 Oct 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Christopher Seymour, University of Pittsburgh
- Investigators
- Christopher Seymour, M.D., Principal investigator, University of Pittsburgh / UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684133
- Sponsor's protocol ID
- STUDY21120013
- Other IDs
- 5R21GM144851-02
- Acronym
- REMISE
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REMISE Study: REMnant Biospecimen Investigation in SEpsis
- ClinicalTrials.gov ID
- NCT05684133
- Acronym / sponsor ID
- REMISE / STUDY21120013
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Vanderbilt University, National Institute of General Medical Sciences (NIGMS)
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Sepsis-3 presenting to eligible emergency departments.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Patients who do not have Sepsis-3
- Traumatic injury,
- Inability to consent or contact legal representative,
- Cardiac arrest,
- Stroke,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in traditional biomarkers, proteomics, pathogen sequencing, and metabolomics/lipidomics between prospectively collected biospecimens and remnant biospecimens.
Time frame: 01/2024
4 secondary outcomes
Measurement of traditional biomarkers in all samples
Time frame: 1/2024
Measurement of proteomics in all samples
Time frame: 1/2024
Measurement of metabolomics/lipidomics in all samples
Time frame: 1/2024
Pathogen sequencing in all samples
Time frame: 1/2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Seymour, M.D. principal investigator
University of Pittsburgh / UPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in traditional biomarkers, proteomics, pathogen sequencing, and metabolomics/lipidomics between prospectively collected biospecimens and remnant biospecimens. (time frame: 01/2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.