SepsisNCT05410665
The Roles of IL-9/E-cadherin and Ferroptosis in Intestinal Mucosal Barrier Injury in Sepsis
An observational study of Sepsis and Intestinal Mucosal Barrier, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The investigators aim to evaluate the roles of IL-9/E-cadheirin and ferroptosis in the intestinal mucosal barrier injury of sepsis. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Intestinal Mucosal Barrier, Ferroptosis
- What is being tested?
- Standard treatments for sepsis
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2022to 30 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Septic patients and baseline data (including age, sex, body-mass index, disease severity scores) matched adult non-septic critical patients in ICU.
Who may be able to join
- Clinical diagnosis of sepsis
- Within 3 days of sepsis onset before ICU admission
- No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission
Who cannot join
- Ileus
- Digestive tract hemorrhage
- Inflammatory bowel disease
- Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)
- Malnutrition or immunodeficiency
- Long-term use of hormones
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210000
Jie Zhou
About this study
The investigators aim to evaluate the roles of IL-9/E-cadheirin and ferroptosis in the intestinal mucosal barrier injury of sepsis. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis.
- Conditions
- Sepsis, Intestinal Mucosal Barrier, Ferroptosis
- Being tested
- Standard treatments for sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatments for sepsisProcedure or surgery
Standard treatments for others
| Study group | Role | What they receive |
|---|---|---|
| Sepsis group | Adult septic patients admitted into the intensive care unit (ICU) of Nanjing First Hospital. The diagnostic criteria for sepsis were in accordance with the surviving sepsis guidelines. Receives: Procedure: Standard treatments for sepsis | |
| Control group | Baseline data (including age, sex, body-mass index, disease severity scores) matched adult non-septic critical patients in our ICU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intestinal barrier injury incidence of intestinal barrier injury
intestinal barrier injury
Measured: 7 days
Secondary outcomes (1)
Incidence of ferroptosis
ferroptosis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start31 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (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.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia-Kui Sun, Dr., Principal investigator, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410665
- Sponsor's protocol ID
- YKK21134
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2022
- Last updated
- 8 Jun 2022
- 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 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Roles of IL-9/E-cadherin and Ferroptosis in Intestinal Mucosal Barrier Injury in Sepsis
- ClinicalTrials.gov ID
- NCT05410665
- Acronym / sponsor ID
- YKK21134
- Conditions
- Sepsis, Intestinal Mucosal Barrier, Ferroptosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 Jun 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.
The investigators aim to evaluate the roles of IL-9/E-cadheirin and ferroptosis in the intestinal mucosal barrier injury of sepsis. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis group | – | Procedure: Standard treatments for sepsisAdult septic patients admitted into the intensive care unit (ICU) of Nanjing First Hospital. The diagnostic criteria for sepsis were in accordance with the surviving sepsis guidelines. |
| Control group | – | –Baseline data (including age, sex, body-mass index, disease severity scores) matched adult non-septic critical patients in our ICU. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Septic patients and baseline data (including age, sex, body-mass index, disease severity scores) matched adult non-septic critical patients in ICU.
Key inclusion criteria (3 listed)
- Clinical diagnosis of sepsis
- Within 3 days of sepsis onset before ICU admission
- No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission
Key exclusion criteria (6 listed)
- Ileus
- Digestive tract hemorrhage
- Inflammatory bowel disease
- Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)
- Malnutrition or immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatments for sepsisStandard treatments for others | Procedure or surgery | Sepsis group |
Primary outcome
Incidence of intestinal barrier injury incidence of intestinal barrier injury
Time frame: 7 days
intestinal barrier injury
1 secondary outcome
Incidence of ferroptosis
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Jia-Kui Sun, Dr. principal investigator
Nanjing First Hospital, Nanjing Medical 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 and Intestinal Mucosal Barrier, run by Nanjing First Hospital, Nanjing Medical University 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 6 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 8 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Zhou, Dr. (+8613913893984, 565219791@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intestinal barrier injury incidence of intestinal barrier injury (time frame: 7 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 8 Jun 2022.