SepsisNCT05640037
Urine Interleukin-37 as a Biomarker of Mortality Risk in Patients With Sepsis
An observational study of Sepsis, run by Zhongnan Hospital at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of IL-37 as a biomarker to predict mortality risk in adults with sepsis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2022to 20 Mar 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: ICU admission with a suspicion of infection
Who may be able to join
- Age 18 years or older
- Expected length of stay>24 hours in intensive care unit (ICU)
- Sequential organ failure assessment (SOFA) score ≥ 2 on ICU admission with a suspicion of infection
Who cannot join
- anuria
- ICU readmission in 28 days
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the efficacy of IL-37 as a biomarker to predict mortality risk in adults with sepsis.
Read the detailed description
Sepsis patients admitted in the Department of Critical Care Medicine, Zhongnan Hospital will be included.
There are three groups of patients in this study: control group, sepsis group and septic shock group.
The interleukin-37 (IL-37) concentration in urine was analyzed in the day 1, 2, 4, 6.
Additionally, IL-37 concentration between blood stream infection groups and non-infection groups were analyzed. IL-37 concentration between survivors and non-survivors were also compared. IL-37 concentration were followed from day 1, 2, 4, 6.The correlation between the concentration of IL-37, IL-1β, IL-6、IL-10 and TNF-α were analyzed. Furthermore, the investigators will determine the correlation between the concentration of IL-37, sepsis associated organ dysfunction, 28-day mortality. Lastly, the predictive value of IL-37 to sepsis associated organ dysfunction and prognosis were explored.
- Conditions
- Sepsis
- Keywords
- sepsis, interleukin-37, biomarker
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
Number of patients who were confirmed to be dead within 28-day from enrollment onto the study
Measured: 28 day
Secondary outcomes (3)
ICU all-cause mortality
Number of patients who were confirmed to be dead in ICU from enrollment onto the study
Measured: 28 day
ICU length of stay
Length of intensive care unit stay
Measured: 28 day
Hospital length of stay
Length of hospital stay
Measured: 28day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start23 Mar 2022
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawei Wang, MD, Study chair, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640037
- Sponsor's protocol ID
- Dawei Wang
- Status last verified
- Dec 2023
- First submitted
- 25 Nov 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Interleukin-37 as a Biomarker of Mortality Risk in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT05640037
- Acronym / sponsor ID
- Dawei Wang
- Conditions
- Sepsis
- Keywords
- sepsis, interleukin-37, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 7 Dec 2022 (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 study aims to evaluate the efficacy of IL-37 as a biomarker to predict mortality risk in adults with sepsis.
Detailed description
Sepsis patients admitted in the Department of Critical Care Medicine, Zhongnan Hospital will be included.
There are three groups of patients in this study: control group, sepsis group and septic shock group.
The interleukin-37 (IL-37) concentration in urine was analyzed in the day 1, 2, 4, 6.
Additionally, IL-37 concentration between blood stream infection groups and non-infection groups were analyzed. IL-37 concentration between survivors and non-survivors were also compared. IL-37 concentration were followed from day 1, 2, 4, 6.The correlation between the concentration of IL-37, IL-1β, IL-6、IL-10 and TNF-α were analyzed. Furthermore, the investigators will determine the correlation between the concentration of IL-37, sepsis associated organ dysfunction, 28-day mortality. Lastly, the predictive value of IL-37 to sepsis associated organ dysfunction and prognosis were explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ICU admission with a suspicion of infection
Key inclusion criteria (3 listed)
- Age 18 years or older
- Expected length of stay>24 hours in intensive care unit (ICU)
- Sequential organ failure assessment (SOFA) score ≥ 2 on ICU admission with a suspicion of infection
Key exclusion criteria (2 listed)
- anuria
- ICU readmission in 28 days
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 all-cause mortality
Time frame: 28 day
Number of patients who were confirmed to be dead within 28-day from enrollment onto the study
3 secondary outcomes
ICU all-cause mortality
Time frame: 28 day
ICU length of stay
Time frame: 28 day
Hospital length of stay
Time frame: 28day
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 8 May 2024.
- Individual participant dataSharing planned: No
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Sepsis
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.
Dawei Wang, MD study chair
Wuhan University
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 Zhongnan Hospital at 1 site in China.
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 3 inclusion and 2 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 8 May 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 China. 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?
28-day all-cause mortality (time frame: 28 day). 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 8 May 2024.