SepsisNCT04979767
Function of Circulating Exosomes in Sepsis-induced Immunosuppression
An observational study of Sepsis and Septic Shock, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Sepsis Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 30 Jun 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized adult patients admitted to the intensive care unit with sepsis
Who may be able to join
- ≥ 50 years with ≥ 2 chronic comorbidities
- Highly suspected bacterial infection based on clinical or radiologic evidence
- ≥ 2 systemic inflammatory response syndrome (SIRS) criteria
- Actual/anticipated admission to intensive care unit (ICU)
- Anticipated length of hospital stay ≥ 5 days
Who cannot join
- Pregnancy
- Underlying immunosuppression (solid organ transplant, hematopoietic stem cell transplant, neutropenia, HIV infection, long-term corticosteroid use (≥ 20 mg prednisone equivalents for ≥ 14 days), immunosuppressants, radiation, chemotherapy, immune-modifying biologics, viral hepatitis, or systemic autoimmune diseases)
- Current immunotherapy use
- Confirmed COVID-19 infection
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Luigi R Boccardi, BS, 913-588-4022, lboccardi@kumc.edu
Vaughn D Craddock, BS, 316-708-7352, vcraddock2@kumc.edu
About this study
This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.
- Conditions
- Sepsis, Septic Shock, Sepsis Syndrome, Sepsis Bacterial, Sepsis, Severe, Sepsis Bacteremia
- Medical subject headings
- Sepsis, Shock, Septic, Systemic Inflammatory Response Syndrome
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 |
|---|---|---|
| Sepsis | I. ≥ 50 years with ≥ 2 chronic comorbidities II. Highly suspected bacterial infection based on clinical or radiologic evidence III. ≥ 2 systemic inflammatory response syndrome (SIRS) criteria IV. Actual/anticipated admission to intensive care unit (ICU) V. Anticipated length of hospital stay ≥ 5 days | |
| Control | I. ≥ 50 years with ≥ 2 chronic comorbidities II. No suspected bacterial infection III. Actual/anticipated admission to intensive care unit (ICU) IV. Anticipated length of hospital stay ≥ 5 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
All-cause mortality
Measured: From enrollment to 28 days
Secondary outcomes (4)
Hospital mortality
All-cause mortality
Measured: From enrollment until hospital discharge, up to 90 days
90-day mortality
All-cause mortality
Measured: From enrollment to 90 days
Length of stay
Hospital length of stay
Measured: From enrollment until hospital discharge, up to 90 days
Duration of infection
Time to resolution of infection
Measured: From enrollment until resolution of SIRS, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start15 Apr 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
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.
- 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas
- Responsible party
- Principal investigator, Nicholas Britt, University of Kansas Medical Center
- Investigators
- Nicholas S Britt, PharmD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979767
- Sponsor's protocol ID
- STUDY#00145638
- Status last verified
- Jul 2021
- First submitted
- 14 May 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function of Circulating Exosomes in Sepsis-induced Immunosuppression
- ClinicalTrials.gov ID
- NCT04979767
- Acronym / sponsor ID
- STUDY#00145638
- Conditions
- Sepsis, Septic Shock, Sepsis Syndrome, Sepsis Bacterial, Sepsis, Severe, Sepsis Bacteremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- University of Kansas
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 28 Jul 2021 (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.
This is a single-center prospective bio-specimen analysis and observational study aiming to define immune pathways disrupted in bacterial sepsis and to identify clinically useful biomarkers of immune status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | –I. ≥ 50 years with ≥ 2 chronic comorbidities II. Highly suspected bacterial infection based on clinical or radiologic evidence III. ≥ 2 systemic inflammatory response syndrome (SIRS) criteria IV. Actual/anticipated admission to intensive care unit (ICU) V. Anticipated length of hospital stay ≥ 5 days |
| Control | – | –I. ≥ 50 years with ≥ 2 chronic comorbidities II. No suspected bacterial infection III. Actual/anticipated admission to intensive care unit (ICU) IV. Anticipated length of hospital stay ≥ 5 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adult patients admitted to the intensive care unit with sepsis
Key inclusion criteria (5 listed)
- ≥ 50 years with ≥ 2 chronic comorbidities
- Highly suspected bacterial infection based on clinical or radiologic evidence
- ≥ 2 systemic inflammatory response syndrome (SIRS) criteria
- Actual/anticipated admission to intensive care unit (ICU)
- Anticipated length of hospital stay ≥ 5 days
Key exclusion criteria (4 listed)
- Pregnancy
- Underlying immunosuppression (solid organ transplant, hematopoietic stem cell transplant, neutropenia, HIV infection, long-term corticosteroid use (≥ 20 mg prednisone equivalents for ≥ 14 days), immunosuppressants, radiation, chemotherapy, immune-modifying biologics, viral hepatitis, or systemic autoimmune diseases)
- Current immunotherapy use
- Confirmed COVID-19 infection
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
28-day mortality
Time frame: From enrollment to 28 days
All-cause mortality
4 secondary outcomes
Hospital mortality
Time frame: From enrollment until hospital discharge, up to 90 days
90-day mortality
Time frame: From enrollment to 90 days
Length of stay
Time frame: From enrollment until hospital discharge, up to 90 days
Duration of infection
Time frame: From enrollment until resolution of SIRS, up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Nicholas S Britt, PharmD principal investigator
University of Kansas Medical Center
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 and Septic Shock, run by University of Kansas Medical Center 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi R Boccardi, BS (913-588-4022, lboccardi@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: From enrollment to 28 days). 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 Jul 2021.