Immunology of Septic ShockIMMUNOSEPSISNCT02803346
Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration (IMMUNOSEPSIS)
An observational study of Immunology of Septic Shock, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Septic syndromes (systemic inflammatory response associated with infection) remain a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunology of Septic Shock
- What is being tested?
- Circulating blood (leukocytes)
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Dec 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: septic shock patients
Who may be able to join
- septic shock is defined by an identifiable site of infection, persisting hypotension despite fluid resuscitation requiring vasopressor therapy, and evidence of a systemic inflammatory response
Who cannot join
- age < 18
- immunosuppressive disease (HIV, cancer, primary immune deficiency)
- immunosuppressive treatment or corticoid treatment (dosage > 10mg/day or cumulative dose >700 mg equivalent prednisolone)
- aplasia as defined by number of circulating neutrophils < 500 cells / mm3
- extracorporeal circulation during the month prior ICU admission
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon - Hopital Edouard Herriot
Lyon, 69003
Guillaume Monneret, +33 4 72 11 97 58, guillaume.monneret@chu-lyon.fr:
About this study
Septic syndromes (systemic inflammatory response associated with infection) remain a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units. While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immunologic response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (CMV or HSV) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. Both arms of immunity (innate and adaptive) are indeed markedly suppressed (including enhanced leukocyte apoptosis, lymphocyte anergy and deactivated monocyte functions). New promising therapeutic avenues are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. The prerequisite for immunostimulation administration (IFNg, GM-CSF, IL-7) however relies on the investigators capacity in identifying the patients who could benefit from it, as there is no clinical sign of immune dysfunctions. The main objectives are:
- to identify the best biomarkers for sepsis-induced immunosuppression and
- to evaluate ex vivo whether drugs could rejuvenate immune functions.
- Conditions
- Immunology of Septic Shock
- Being tested
- Circulating blood (leukocytes)
- Keywords
- sepsis, septic shock, immunosuppression, HLA-DR, lymphopenia
- Medical subject headings
- Sepsis, Shock, Septic, Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating blood (leukocytes)Other
mHLA-DR measurement (in vitro)
| Study group | Role | What they receive |
|---|---|---|
| septic shock patients | Not described Receives: Other: Circulating blood (leukocytes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 28 days post diagnosis
Secondary outcomes (2)
occurrence of nosocomial infection
Measured: 28 days post diagnosis
decreased monocyte HLA-DR expression
Measured: day 3 post diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJan 2009
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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 Immunology of Septic ShockStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803346
- Sponsor's protocol ID
- D50620
- Acronym
- IMMUNOSEPSIS
- Status last verified
- Jun 2016
- First submitted
- 14 Jun 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bodinier M, Peronnet E, Brengel-Pesce K, Conti F, Rimmele T, Textoris J, Vedrine C, Quemeneur L, Griffiths AD, Tan LK, Venet F, Maucort-Boulch D, Monneret G; REALISM study group. Monocyte Trajectories Endotypes Are Associated With Worsening in Septic Patients. Front Immunol. 2021 Nov 29;12:795052. doi: 10.3389/fimmu.2021.795052. eCollection 2021.
PubMed 34912347
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration (IMMUNOSEPSIS)
- ClinicalTrials.gov ID
- NCT02803346
- Acronym / sponsor ID
- IMMUNOSEPSIS / D50620
- Conditions
- Immunology of Septic Shock
- Keywords
- sepsis, septic shock, immunosuppression, HLA-DR, lymphopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 16 Jun 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.
Septic syndromes (systemic inflammatory response associated with infection) remain a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units. While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immunologic response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (CMV or HSV) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. Both arms of immunity (innate and adaptive) are indeed markedly suppressed (including enhanced leukocyte apoptosis, lymphocyte anergy and deactivated monocyte functions). New promising therapeutic avenues are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. The prerequisite for immunostimulation administration (IFNg, GM-CSF, IL-7) however relies on the investigators capacity in identifying the patients who could benefit from it, as there is no clinical sign of immune dysfunctions. The main objectives are:
- to identify the best biomarkers for sepsis-induced immunosuppression and
- to evaluate ex vivo whether drugs could rejuvenate immune functions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| septic shock patients | – | Other: Circulating blood (leukocytes) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- septic shock patients
Key inclusion criteria (1 listed)
- septic shock is defined by an identifiable site of infection, persisting hypotension despite fluid resuscitation requiring vasopressor therapy, and evidence of a systemic inflammatory response
Key exclusion criteria (5 listed)
- age < 18
- immunosuppressive disease (HIV, cancer, primary immune deficiency)
- immunosuppressive treatment or corticoid treatment (dosage > 10mg/day or cumulative dose >700 mg equivalent prednisolone)
- aplasia as defined by number of circulating neutrophils < 500 cells / mm3
- extracorporeal circulation during the month prior ICU admission
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 |
|---|---|---|
| Circulating blood (leukocytes)mHLA-DR measurement (in vitro) | Other | septic shock patients |
Primary outcome
mortality
Time frame: 28 days post diagnosis
2 secondary outcomes
occurrence of nosocomial infection
Time frame: 28 days post diagnosis
decreased monocyte HLA-DR expression
Time frame: day 3 post diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Derived from this study: PubMed 34912347Bodinier M, Peronnet E, Brengel-Pesce K, Conti F, Rimmele T, Textoris J, Vedrine C, Quemeneur L, Griffiths AD, Tan LK, Venet F, Maucort-Boulch D, Monneret G; REALISM study group. Monocyte Trajectories Endotypes Are Associated With Worsening in Septic Patients. Front Immunol. 2021 Nov 29;12:795052. doi: 10.3389/fimmu.2021.795052. eCollection 2021.
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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.
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 Immunology of Septic Shock, run by Hospices Civils de Lyon 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 1 inclusion and 5 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 16 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Monneret (+33 4 72 11 97 58, guillaume.monneret@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 28 days post diagnosis). 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 NCT02803346, 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 16 Jun 2016.