SepsisNCT02883218
Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis Patients
An observational study of Sepsis, run by Jianfeng Xie at 1 site in China.
Trial summary
To evaluate the dynamic alterations of Th2/Th1 for the prediction of clinical immunity and how it was related to 28 day-prognosis and ICU-acquired infections among critically ill patients of community-acquired severe sepsis with new onset. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to 1 Aug 2018
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We enroll patients with community-acquired severe sepsis and then the patients admitted to ICU without the diagnosis of severe sepsis as ICU control group, and the heathy volunteers as healthy control group.
Who may be able to join
- at least 18 years of age and no more than 90 years of age
- sepsis was defined according to consensus criteria
- diagnosis of sepsis and complicatied with organ dysfunction no longer than 48 h
- provided written informed consent.
- at least 18 years of age and no more than 90 years of age
- without diagnosis of sepsis and admitted to ICU
Show all 9Show fewer
- provided written informed consent.
- at least 18 years of age and no more than 90 years of age
- provided written informed consent.
Who cannot join
- diagnosis of hematological,immunological disease or cancer
- treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization
- For non-severe sepsis ICU control group:
- diagnosis of hematological,immunological disease or cancer
- treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization
- For healthy control group:
- diagnosis of hematological,immunological disease or cancer
- treatment with chemotherapy agents or corticosteroids within 6 months prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis
To evaluate the dynamic alterations of Th2/Th1 for the prediction of clinical immunity and how it was related to 28 day-prognosis and ICU-acquired infections among critically ill patients of community-acquired severe sepsis with new onset.
- Conditions
- Sepsis
- Keywords
- immunosuppression, community-acquired sepsis, mortality
- 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 |
|---|---|---|
| Comunity-acquired severe sepsis patients | Patients with new-onset community-acquired severe sepsis within 24h without confounding factors in immune status | |
| Non-severe sepsis patients | Patients between 18 and 90 years of age and be admitted to the ICU without a diagnosis of severe sepsis. | |
| Healthy controls | Heathy vonlunteers between 18 and 90 years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Th2/Th1 upon enrollment
The blood samples were collected for T helper 1 cells and T helper 2 cells populations measured by flow cytometry. All groups are needed.
Measured: Day 0 after enrollment for community-acquired severe sepsis group and Day 0 after enrollment for the non-severe sepsis patients and heathy control group
Th2/Th1 on Day 3
populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.
Measured: Day 3 after enrollment for community-acquired severe sepsis group
Th2/Th1 on Day 7
populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.
Measured: Day 7 after enrollment for community-acquired severe sepsis group
Secondary outcomes (2)
28-day mortality for community-acquired severe sepsis group
Measured: 28-day
ICU-acquired infection for community-acquired severe sepsis group
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startSep 2014
- Primary completion20 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883218
- Sponsor's protocol ID
- 2014ZDSYLL087.0
- Status last verified
- Aug 2018
- First submitted
- 25 Aug 2016
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xue M, Xie J, Liu L, Huang Y, Guo F, Xu J, Yang Y, Qiu H. Early and dynamic alterations of Th2/Th1 in previously immunocompetent patients with community-acquired severe sepsis: a prospective observational study. J Transl Med. 2019 Feb 27;17(1):57. doi: 10.1186/s12967-019-1811-9.
PubMed 30813927
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Alterations of Th2/Th1 With New Onset of Community-acquired Severe Sepsis
- ClinicalTrials.gov ID
- NCT02883218
- Acronym / sponsor ID
- 2014ZDSYLL087.0
- Conditions
- Sepsis
- Keywords
- immunosuppression, community-acquired sepsis, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 30 Aug 2016 (estimated)
- 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.
To evaluate the dynamic alterations of Th2/Th1 for the prediction of clinical immunity and how it was related to 28 day-prognosis and ICU-acquired infections among critically ill patients of community-acquired severe sepsis with new onset.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Comunity-acquired severe sepsis patients | – | –Patients with new-onset community-acquired severe sepsis within 24h without confounding factors in immune status |
| Non-severe sepsis patients | – | –Patients between 18 and 90 years of age and be admitted to the ICU without a diagnosis of severe sepsis. |
| Healthy controls | – | –Heathy vonlunteers between 18 and 90 years of age. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We enroll patients with community-acquired severe sepsis and then the patients admitted to ICU without the diagnosis of severe sepsis as ICU control group, and the heathy volunteers as healthy control group.
Key inclusion criteria (9 listed)
- at least 18 years of age and no more than 90 years of age
- sepsis was defined according to consensus criteria
- diagnosis of sepsis and complicatied with organ dysfunction no longer than 48 h
- provided written informed consent.
- at least 18 years of age and no more than 90 years of age
Key exclusion criteria (8 listed)
- diagnosis of hematological,immunological disease or cancer
- treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization
- diagnosis of hematological,immunological disease or cancer
- treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization
- diagnosis of hematological,immunological disease or cancer
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
Th2/Th1 upon enrollment
Time frame: Day 0 after enrollment for community-acquired severe sepsis group and Day 0 after enrollment for the non-severe sepsis patients and heathy control group
The blood samples were collected for T helper 1 cells and T helper 2 cells populations measured by flow cytometry. All groups are needed.
Th2/Th1 on Day 3
Time frame: Day 3 after enrollment for community-acquired severe sepsis group
populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.
Th2/Th1 on Day 7
Time frame: Day 7 after enrollment for community-acquired severe sepsis group
populations measured by flow cytometry. Only community-acquired severe sepsis group is needed.
2 secondary outcomes
28-day mortality for community-acquired severe sepsis group
Time frame: 28-day
ICU-acquired infection for community-acquired severe sepsis group
Time frame: 28-day
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 21 Aug 2018.
- Derived from this study: PubMed 30813927Xue M, Xie J, Liu L, Huang Y, Guo F, Xu J, Yang Y, Qiu H. Early and dynamic alterations of Th2/Th1 in previously immunocompetent patients with community-acquired severe sepsis: a prospective observational study. J Transl Med. 2019 Feb 27;17(1):57. doi: 10.1186/s12967-019-1811-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Jianfeng Xie 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 9 inclusion and 8 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 21 Aug 2018. 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?
Th2/Th1 upon enrollment (time frame: Day 0 after enrollment for community-acquired severe sepsis group and Day 0 after enrollment for the non-severe sepsis patients and heathy control group). The study lists 3 primary outcomes in all. 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 NCT02883218, which also lists 1 linked publication.
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 21 Aug 2018.