SepsisIMITSNCT04903405
Immune Function Monitoring and Immunotherapy in Sepsis
An observational study of Sepsis and Septic Shock, run by Sun Yat-sen University.
Trial summary
At present, the clinical studies of various anti-inflammatory drugs and immune-enhancing drugs show that immunotherapy will bring new hope for the treatment of sepsis. In order to further understand the current status of immunotherapy in China, this study aims to understand the current status and standardization of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 30 Jul 2021
- How long will I take part?
- 28 Days
- 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: The patient was diagnosed with sepsis or septic shock according to Sepsis 3.0
Who may be able to join
- Patients with sepsis or septic shock according to Sepsis 3.0
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Immune Function Monitoring and Immunotherapy in Sepsis: a Cross-sectional Survey in China
At present, the clinical studies of various anti-inflammatory drugs and immune-enhancing drugs show that immunotherapy will bring new hope for the treatment of sepsis. In order to further understand the current status of immunotherapy in China, this study aims to understand the current status and standardization of the use of sepsis immunosurveillance and immunotherapy in hospitals through a cross-sectional survey.
- Conditions
- Sepsis, Septic Shock
- Being tested
- No intervention
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention is involved in this study
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Measured: 28 days
Secondary outcomes (2)
Percentage of sepsis patients receiving immune function monitoring
Measured: 28 days
Percentage of sepsis patients receiving immunotherapy
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Jianfeng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903405
- Sponsor's protocol ID
- IMITS
- Acronym
- IMITS
- Status last verified
- May 2021
- First submitted
- 23 May 2021
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pei F, Zhang GR, Zhou LX, Liu JY, Ma G, Kou QY, He ZJ, Chen MY, Nie Y, Wu JF, Guan XD; China Critical Care Immunotherapy Research Group. Early Immunoparalysis Was Associated with Poor Prognosis in Elderly Patients with Sepsis: Secondary Analysis of the ETASS Study. Infect Drug Resist. 2020 Jun 30;13:2053-2061. doi: 10.2147/IDR.S246513. eCollection 2020.
PubMed 32636658Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.
PubMed 23327199Wu JF, Ma J, Chen J, Ou-Yang B, Chen MY, Li LF, Liu YJ, Lin AH, Guan XD. Changes of monocyte human leukocyte antigen-DR expression as a reliable predictor of mortality in severe sepsis. Crit Care. 2011;15(5):R220. doi: 10.1186/cc10457. Epub 2011 Sep 20.
PubMed 21933399
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Function Monitoring and Immunotherapy in Sepsis: a Cross-sectional Survey in China
- ClinicalTrials.gov ID
- NCT04903405
- Acronym / sponsor ID
- IMITS / IMITS
- Conditions
- Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 26 May 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.
At present, the clinical studies of various anti-inflammatory drugs and immune-enhancing drugs show that immunotherapy will bring new hope for the treatment of sepsis. In order to further understand the current status of immunotherapy in China, this study aims to understand the current status and standardization of the use of sepsis immunosurveillance and immunotherapy in hospitals through a cross-sectional survey.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient was diagnosed with sepsis or septic shock according to Sepsis 3.0
Key inclusion criteria (1 listed)
- Patients with sepsis or septic shock according to Sepsis 3.0
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No interventionNo intervention is involved in this study | Other | Sepsis |
Primary outcome
28-day mortality
Time frame: 28 days
2 secondary outcomes
Percentage of sepsis patients receiving immune function monitoring
Time frame: 28 days
Percentage of sepsis patients receiving immunotherapy
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Background: PubMed 32636658Pei F, Zhang GR, Zhou LX, Liu JY, Ma G, Kou QY, He ZJ, Chen MY, Nie Y, Wu JF, Guan XD; China Critical Care Immunotherapy Research Group. Early Immunoparalysis Was Associated with Poor Prognosis in Elderly Patients with Sepsis: Secondary Analysis of the ETASS Study. Infect Drug Resist. 2020 Jun 30;13:2053-2061. doi: 10.2147/IDR.S246513. eCollection 2020.
- Background: PubMed 23327199Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.
- Background: PubMed 21933399Wu JF, Ma J, Chen J, Ou-Yang B, Chen MY, Li LF, Liu YJ, Lin AH, Guan XD. Changes of monocyte human leukocyte antigen-DR expression as a reliable predictor of mortality in severe sepsis. Crit Care. 2011;15(5):R220. doi: 10.1186/cc10457. Epub 2011 Sep 20.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Sun Yat-sen University.
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 1 inclusion and 1 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 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Jianfeng Wu (020-87755766-8453, wujianf@mail.sysu.edu.cn), 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: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04903405, which also lists 3 linked publications.
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 26 May 2021.