SepsisNCT01976884
Expression and the Clinical Significance of Neutrophil PD-L1 During Sepsis
An observational study of Sepsis and Immunosuppression, run by Changhai Hospital.
Trial summary
Immunosuppression is the leading cause of death in septic patients. Neutrophils are classical components of innate immunology, but recent studies showed that neutrophils might display antigen presenting function and inhibit lymphocyte proliferation by expressing programmed cell death 1 ligand 1 (PD-L1). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Immunosuppression
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jan 2013
- 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: Patients admitted in ICU at Changhai Hospital
Who may be able to join
- patients with severe sepsis
- patients with sepsis after PCNL for infectious kidney stone
- patients with pancreatic cancer
- healthy volunteers
Who cannot join
- patients with immunodeficient diseases
- patients who accept glucocorticoid or immunosuppressant
- patients with an age older than 18 years
- patients providing the informed consent
About this study
Immunosuppression is the leading cause of death in septic patients. Neutrophils are classical components of innate immunology, but recent studies showed that neutrophils might display antigen presenting function and inhibit lymphocyte proliferation by expressing programmed cell death 1 ligand 1 (PD-L1). Whether neutrophils express PD-L1 and its role in immunosuppression during sepsis remain unclear.
- Conditions
- Sepsis, Immunosuppression
- Keywords
- sepsis, immunosuppression, PD-L1
- 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 |
|---|---|---|
| Severe sepsis | Patients with severe sepsis | |
| Infectious kidney stone | Patients with sepsis after PCNL for infectious kidney stone | |
| Tumor | Patients with pancreatic cancer | |
| Volunteer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD-L1 level on neutrophils
PD-L1 level on neutrophils was compared between different populations.
Measured: within 24h after recruitment
Secondary outcomes (1)
28-day mortality
Measured: 28 days after diagnosis of sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionJan 2013
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 Changhai HospitalThe 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-control
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-feng Wang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976884
- Sponsor's protocol ID
- NeutrophilPD-L1
- Status last verified
- Oct 2013
- First submitted
- 30 Oct 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression and the Clinical Significance of Neutrophil PD-L1 During Sepsis
- ClinicalTrials.gov ID
- NCT01976884
- Acronym / sponsor ID
- NeutrophilPD-L1
- Conditions
- Sepsis, Immunosuppression
- Keywords
- sepsis, immunosuppression, PD-L1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 6 Nov 2013 (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.
Immunosuppression is the leading cause of death in septic patients. Neutrophils are classical components of innate immunology, but recent studies showed that neutrophils might display antigen presenting function and inhibit lymphocyte proliferation by expressing programmed cell death 1 ligand 1 (PD-L1). Whether neutrophils express PD-L1 and its role in immunosuppression during sepsis remain unclear.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Severe sepsis | – | –Patients with severe sepsis |
| Infectious kidney stone | – | –Patients with sepsis after PCNL for infectious kidney stone |
| Tumor | – | –Patients with pancreatic cancer |
| Volunteer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU at Changhai Hospital
Key inclusion criteria (4 listed)
- patients with severe sepsis
- patients with sepsis after PCNL for infectious kidney stone
- patients with pancreatic cancer
- healthy volunteers
Key exclusion criteria (4 listed)
- patients with immunodeficient diseases
- patients who accept glucocorticoid or immunosuppressant
- patients with an age older than 18 years
- patients providing the informed consent
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
PD-L1 level on neutrophils
Time frame: within 24h after recruitment
PD-L1 level on neutrophils was compared between different populations.
1 secondary outcome
28-day mortality
Time frame: 28 days after diagnosis of sepsis
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 6 Nov 2013.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Immunosuppression, run by Changhai Hospital.
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 4 inclusion and 4 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 6 Nov 2013. 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?
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?
PD-L1 level on neutrophils (time frame: within 24h after recruitment). 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 6 Nov 2013.