SepsisDENDRISEPSISNCT03788772
Systems Analysis of Antigen Presenting Cells in Human Sepsis
A study testing Multiple blood sampling and Simple blood sampling in people with Sepsis and Acute Circulatory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Sepsis is a common life-threatening inflammatory response to infection and is the leading cause of death in the intensive care unit. Septic patients exhibit a complex immunosuppressive response affecting both innate and adaptive components of immunity, with a possible link to nosocomial infections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Acute Circulatory Failure
- What is being tested?
- Multiple blood sampling and Simple blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2019to 24 Aug 2022
- Phase
- Interventional
- 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
Who may be able to join
- ICU patients with severe infections (Sepsis-3 definitions):
- clinically or microbiologically documented infection and organ dysfunction graded as follows:
- Sepsis: increase in the Sequential Organ Failure Assessment (SOFA) score of 2 points or more.
- Septic shock: vasopressor requirement to maintain a mean arterial pressure ≥ 65mmHg and serum lactate level > 2 mmol/L in the absence of hypovolemia
- ICU patients with non-septic acute circulatory failure:
- Cardiogenic shock: left ventricle systolic dysfunction (echocardiographic left ventricular ejection fraction < 45%) and the need of vasopressor (norepinephrine at any dose and inotropic support (dobutamine ≥ 5 µg/kg/min or epinephrine at any dose) in the absence of patent infection.
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- Severe hemorrhage: hypotension with acute blood loss requiring transfusion of at least four packed red cells within 24h and vasopressor support by norepinephrine or epinephrine at any dose.
- Healthy controls:
- Blood donors
- Patients undergoing elective cataract surgery
Who cannot join
- All ICU patients
- hematological malignancy (or significant history of bone marrow disease),
- HIV infection at any stage,
- any immunosuppressive drugs including corticosteroids ≥ 0.5 mg/kg equivalent prednisone per day for more 7 days,
- anticancer chemotherapy or chemotherapy received during the last three months before inclusion
- bone marrow or solid organ transplantation,
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- leucopenia (<1000/mm3) excepted if due to sepsis,
- pregnancy
- do-not-resuscitate order at ICU admission
- patients under legal protection regimen.
- Healthy controls
- history of inflammatory disease
- hematological malignancy (or significant history of bone marrow disease),
- HIV infection at any stage,
- any immunosuppressive drugs including corticosteroids ≥ 0.5 mg/kg equivalent prednisone per day for more 7 days,
- anticancer chemotherapy or immunotherapy received during the last three months before inclusion
- bone marrow or solid organ transplantation,
- pregnancy
- infectious symptoms within the previous month
- subjects under legal protection regimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systems Analysis of Antigen Presenting Cells in Human Sepsis.
Sepsis is a common life-threatening inflammatory response to infection and is the leading cause of death in the intensive care unit. Septic patients exhibit a complex immunosuppressive response affecting both innate and adaptive components of immunity, with a possible link to nosocomial infections. However, the molecular and cellular mechanisms resulting in secondary immunosuppression remain poorly understood, but may involve the antigen-presenting cells (APC, including dendritic cells and monocytes/macrophages) that link innate and adaptive immunity. Furthermore, the increasing phenotypic and functional heterogeneity of APC subsets raise the question of their respective role in sepsis. We propose to address the pathophysiologal role of APC using systems biology approaches in human sepsis.
The objective is to go from low- to high-resolution analysis of APC subset diversity and underlying molecular and functional features in sepsis. The global objective will be reached through:
Read more
- Systematic description and phenotypic analysis of circulating APC subsets in sepsis
- Association of APC subsets distribution, phenotype and function with severe sepsis physiopathology and relevant clinical outcomes (ICU-acquired infections and death)
- High-resolution molecular profiling of circulating APC subsets using population level and single cell RNAseq.
To this aim, the investigator designed a prospective interventional study in order to collect blood samples at significant time points in patients with sepsis or septic shock (the population of interest) and relevant control subjects, either critically ill patients with non-septic acute circulatory failure or age-matched healthy subjects. The study's intervention is limited to additional blood samples. The risks and constraints are related to additional blood samples (maximum 120mL), which will be performed either from an arterial catheter when present in ICU patients, or from a venous puncture for patients without arterial catheters and for healthy volunteers.
- Conditions
- Sepsis, Acute Circulatory Failure
- Being tested
- Multiple blood sampling, Simple blood sampling
- Keywords
- dendritic cell, sepsis
- Medical subject headings
- Sepsis, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple blood samplingOther
ICU septic and non-septic patients will be subjected to repeated blood samples at the following time-points: ICU admission, day 4/5, ICU and hospital discharge, 3 months. Patients exhibiting ICU-acquired infection will also be sampled at the time of diagnosis (up to 6 additional blood samples of 20 mL within 3 months = 120mL)
Simple blood samplingOther
Healthy controls (blood donors and patients undergoing elective cataract surgery) will be subjected to one single blood sample of 20 mL.
| Study group | Role | What they receive |
|---|---|---|
| Adults patients hospitalized in ICU | Experimental | Adult patients hospitalized in the intensive care unit (ICU) for severe infections (sepsis and septic shock) or or non-septic shock (cardiogenic or hemorrhagic shock) Receives: Other: Multiple blood sampling; Other: Simple blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU-acquired infections (nosocomial infections)
Infections not present at the time of ICU admission and diagnosed at least after 48 hours in the ICU
Measured: up to 3 months after the inclusion
Secondary outcomes (1)
In-hospital death
date of death
Measured: up to 3 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start15 Jul 2019
- Primary completion23 May 2022
- Study completion24 Aug 2022
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Frédéric PENE, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisVassili SOUMELIS, MD PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788772
- Sponsor's protocol ID
- APHP180016
- Other IDs
- 2018-A01934-51
- Acronym
- DENDRISEPSIS
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2018
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saichi M, Ladjemi MZ, Korniotis S, Rousseau C, Ait Hamou Z, Massenet-Regad L, Amblard E, Noel F, Marie Y, Bouteiller D, Medvedovic J, Pene F, Soumelis V. Single-cell RNA sequencing of blood antigen-presenting cells in severe COVID-19 reveals multi-process defects in antiviral immunity. Nat Cell Biol. 2021 May;23(5):538-551. doi: 10.1038/s41556-021-00681-2. Epub 2021 May 10.
PubMed 33972731
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Analysis of Antigen Presenting Cells in Human Sepsis.
- ClinicalTrials.gov ID
- NCT03788772
- Acronym / sponsor ID
- DENDRISEPSIS / APHP180016
- Conditions
- Sepsis, Acute Circulatory Failure
- Keywords
- dendritic cell, sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 28 Dec 2018 (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.
Sepsis is a common life-threatening inflammatory response to infection and is the leading cause of death in the intensive care unit. Septic patients exhibit a complex immunosuppressive response affecting both innate and adaptive components of immunity, with a possible link to nosocomial infections. However, the molecular and cellular mechanisms resulting in secondary immunosuppression remain poorly understood, but may involve the antigen-presenting cells (APC, including dendritic cells and monocytes/macrophages) that link innate and adaptive immunity. Furthermore, the increasing phenotypic and functional heterogeneity of APC subsets raise the question of their respective role in sepsis. We propose to address the pathophysiologal role of APC using systems biology approaches in human sepsis.
The objective is to go from low- to high-resolution analysis of APC subset diversity and underlying molecular and functional features in sepsis. The global objective will be reached through:
- Systematic description and phenotypic analysis of circulating APC subsets in sepsis
- Association of APC subsets distribution, phenotype and function with severe sepsis physiopathology and relevant clinical outcomes (ICU-acquired infections and death)
- High-resolution molecular profiling of circulating APC subsets using population level and single cell RNAseq.
To this aim, the investigator designed a prospective interventional study in order to collect blood samples at significant time points in patients with sepsis or septic shock (the population of interest) and relevant control subjects, either critically ill patients with non-septic acute circulatory failure or age-matched healthy subjects. The study's intervention is limited to additional blood samples. The risks and constraints are related to additional blood samples (maximum 120mL), which will be performed either from an arterial catheter when present in ICU patients, or from a venous puncture for patients without arterial catheters and for healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults patients hospitalized in ICU | Experimental | Other: Multiple blood sampling, Other: Simple blood samplingAdult patients hospitalized in the intensive care unit (ICU) for severe infections (sepsis and septic shock) or or non-septic shock (cardiogenic or hemorrhagic shock) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ICU patients with severe infections (Sepsis-3 definitions):
- clinically or microbiologically documented infection and organ dysfunction graded as follows:
- ICU patients with non-septic acute circulatory failure:
- Healthy controls:
Key exclusion criteria (20 listed)
- All ICU patients
- Healthy controls
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 |
|---|---|---|
| Multiple blood samplingICU septic and non-septic patients will be subjected to repeated blood samples at the following time-points: ICU admission, day 4/5, ICU and hospital discharge, 3 months. Patients exhibiting ICU-acquired infection will also be sampled at the time of diagnosis (up to 6 additional blood samples of 20 mL within 3 months = 120mL) | Other | Adults patients hospitalized in ICU |
| Simple blood samplingHealthy controls (blood donors and patients undergoing elective cataract surgery) will be subjected to one single blood sample of 20 mL. | Other | Adults patients hospitalized in ICU |
Primary outcome
ICU-acquired infections (nosocomial infections)
Time frame: up to 3 months after the inclusion
Infections not present at the time of ICU admission and diagnosed at least after 48 hours in the ICU
1 secondary outcome
In-hospital death
Time frame: up to 3 months after the inclusion
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 12 Sep 2025.
- Results publication: PubMed 33972731Saichi M, Ladjemi MZ, Korniotis S, Rousseau C, Ait Hamou Z, Massenet-Regad L, Amblard E, Noel F, Marie Y, Bouteiller D, Medvedovic J, Pene F, Soumelis V. Single-cell RNA sequencing of blood antigen-presenting cells in severe COVID-19 reveals multi-process defects in antiviral immunity. Nat Cell Biol. 2021 May;23(5):538-551. doi: 10.1038/s41556-021-00681-2. Epub 2021 May 10.
- Individual participant dataSharing planned: No
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
Frédéric PENE, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Vassili SOUMELIS, MD PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple blood sampling and Simple blood sampling in people with Sepsis and Acute Circulatory Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 20 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 12 Sep 2025. 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 France. 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?
ICU-acquired infections (nosocomial infections) (time frame: up to 3 months after the inclusion). 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 NCT03788772, 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 12 Sep 2025.