SepsisNCT01161745
PD-1/PD-L1 Pathway Study on Septic Patients
An observational study of Sepsis, run by Changhai Hospital.
Trial summary
The investigators want to identify that whether PD-1/PD-L1 pathway will change in human sepsis, and whether PD-1/PD-L1 pathway play an important role in sepsis induced immunosuppression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Apr 2010
- 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 who develop sepsis
Who may be able to join
- patients who develop sepsis
Who cannot join
- patients with cirrhosis or renal dysfunction
- patients with dyscrasia
- patients with autoimmunity diseases
- patients with severe cardiac and pulmonary diseases
- patients with hematological diseases
- patients with diabetes mellitus
- patients with malignant tumors
About this study
Official title: PD-1/PD-L1 Pathway in T Lymphocyte Apoptosis and Monocyte Dysfunction in Septic Patients
The investigators want to identify that whether PD-1/PD-L1 pathway will change in human sepsis, and whether PD-1/PD-L1 pathway play an important role in sepsis induced immunosuppression.
Read the detailed description
First, we will detect PD-L1 expression on PBMC of septic patients and healthy controls.
Second, blockade of PD-1/PD-L1 pathway in vitro and stimulate with some biomolecules and then analyze the PBMC function and apoptosis by flow cytometry.
Then, compare with healthy controls and find the differences.
- Conditions
- Sepsis
- Keywords
- sepsis
- Medical subject headings
- Sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startDec 2008
- Primary completionFeb 2010
- Study completionApr 2010
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Investigators
- Xiao-ming Deng, doctor, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161745
- Sponsor's protocol ID
- ANETHDEPT-001
- Status last verified
- Jun 2010
- First submitted
- 13 Jul 2010
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1/PD-L1 Pathway in T Lymphocyte Apoptosis and Monocyte Dysfunction in Septic Patients
- ClinicalTrials.gov ID
- NCT01161745
- Acronym / sponsor ID
- ANETHDEPT-001
- Conditions
- Sepsis
- Keywords
- sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Jul 2010 (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 investigators want to identify that whether PD-1/PD-L1 pathway will change in human sepsis, and whether PD-1/PD-L1 pathway play an important role in sepsis induced immunosuppression.
Detailed description
First, we will detect PD-L1 expression on PBMC of septic patients and healthy controls.
Second, blockade of PD-1/PD-L1 pathway in vitro and stimulate with some biomolecules and then analyze the PBMC function and apoptosis by flow cytometry.
Then, compare with healthy controls and find the differences.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who develop sepsis
Key inclusion criteria (1 listed)
- patients who develop sepsis
Key exclusion criteria (7 listed)
- patients with cirrhosis or renal dysfunction
- patients with dyscrasia
- patients with autoimmunity diseases
- patients with severe cardiac and pulmonary diseases
- patients with hematological diseases
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
Not reported in the source record.
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 14 Jul 2010.
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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.
Xiao-ming Deng, doctor principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, 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 1 inclusion and 7 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 14 Jul 2010. 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.
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 14 Jul 2010.