SepsisNCT02957279
Dendritic Cells-Derived Exosomes in Human Sepsis
An observational study of Sepsis, run by Jinling Hospital, China at 1 site in China.
Trial summary
The amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced infection. The primary objectives of this study are to compare the changes of peripheral blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Antibiotics
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Oct 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were admitted to Jinling Hospital from November, 2016.
Who may be able to join
- Patients were selected with the diagnostic standard "Sepsis 3.0".
- Healthy volunteers do not have serious illness.
Who cannot join
- Patients or volunteers do not agree to provide written informed consent and / or can not be legally authorized to provide informed consent.
- Patients give up treatments.
- Patients or volunteers withdrew from the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Jianan Ren, MD, 862580860108, jiananr@gmail.com
Yuan Li, MD, 8615751866716, liyuan9006@gmail.com
About this study
Official title: A Cohort Study to Investigate the Impacts of Peripheral Blood Dendritic Cells-Derived Exosomes at Early Phase on the Prognosis in Human Sepsis
The amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced infection. The primary objectives of this study are to compare the changes of peripheral blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls.
Read the detailed description
This is a prospective, single-centered, clinical cohort study.
- Conditions
- Sepsis
- Being tested
- Antibiotics
- Keywords
- sepsis, exosomes, dendritic cell
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
In the sepsis group, antibiotics were used when needed.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis group | The patients were admitted to the Jinling Hospital, who met the diagnosis of sepsis(Sepsis 3.0). Receives: Drug: Antibiotics | |
| Healthy control group | Healthy volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of dendritic cell-derived exosomes
Measured: The first 4 hour after admission
Secondary outcomes (1)
Compositions of microRNA in the dendritic cell-derived exosomes
Measured: The first 4 hour after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianan Ren, Jinling Hospital, China
- Investigators
- Jianan Ren, MD, Principal investigator, Jinling Hospital, Medical School of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957279
- Sponsor's protocol ID
- 20161103
- Status last verified
- Nov 2016
- First submitted
- 4 Nov 2016
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study to Investigate the Impacts of Peripheral Blood Dendritic Cells-Derived Exosomes at Early Phase on the Prognosis in Human Sepsis
- ClinicalTrials.gov ID
- NCT02957279
- Acronym / sponsor ID
- 20161103
- Conditions
- Sepsis
- Keywords
- sepsis, exosomes, dendritic cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 7 Nov 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.
The amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced infection. The primary objectives of this study are to compare the changes of peripheral blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls.
Detailed description
This is a prospective, single-centered, clinical cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis group | – | Drug: AntibioticsThe patients were admitted to the Jinling Hospital, who met the diagnosis of sepsis(Sepsis 3.0). |
| Healthy control group | – | –Healthy volunteers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were admitted to Jinling Hospital from November, 2016.
Key inclusion criteria (2 listed)
- Patients were selected with the diagnostic standard "Sepsis 3.0".
- Healthy volunteers do not have serious illness.
Key exclusion criteria (3 listed)
- Patients or volunteers do not agree to provide written informed consent and / or can not be legally authorized to provide informed consent.
- Patients give up treatments.
- Patients or volunteers withdrew from the study.
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 |
|---|---|---|
| AntibioticsIn the sepsis group, antibiotics were used when needed. | Drug | Sepsis group |
Primary outcome
Amount of dendritic cell-derived exosomes
Time frame: The first 4 hour after admission
1 secondary outcome
Compositions of microRNA in the dendritic cell-derived exosomes
Time frame: The first 4 hour after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
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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.
Jianan Ren, MD principal investigator
Jinling Hospital, Medical School of Nanjing 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 Jinling Hospital, China 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 2 inclusion and 3 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 7 Nov 2016. 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 Jianan Ren, MD (862580860108, jiananr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of dendritic cell-derived exosomes (time frame: The first 4 hour after admission). 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 7 Nov 2016.