Descriptive Study of the Evolution in Proportion of Regulatory B Lymphocytes in Patients Hospitalized in Intensive Care for Severe Sepsis (DELyBREG)
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|ClinicalTrials.gov Identifier: NCT03115125|
Recruitment Status : Unknown
Verified April 2017 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was: Recruiting
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Severe sepsis and septic shock are the most severe forms of sepsis (which associates a systemic inflammatory response with infection). These are serious pathologies with a lethality estimated at almost 40% at 28 days (after the onset of sepsis).
After a first pro-inflammatory phase, a second compensatory phase called Compensatory Anti-Inflammatory Response Syndrome (CARS) takes place quickly. Patients then show signs of immunosuppression and profound alterations in immune functions. It is during this phase that the vast majority of deaths occur, far from the onset of the shock, which is related to the inability of the immune system to eliminate the initial infectious agent and / or a greater susceptibility Important to develop secondary infections (nosocomial infection, latent virus reactivation ...).
The CARS phase has been the subject of studies focusing on measuring the plasma concentration of anti-inflammatory cytokines (such as Interleukin (IL) -10), the percentage of regulatory T lymphocytes (Treg), Or the percentage of monocytic expression of HLA-DR in septic patients.
The investigator proposes to carry out the first study on a newly described regulatory lymphocytic subpopulation: regulatory B lymphocytes (Breg) from a quantitative and functional point of view in severe septic states.
|Condition or disease||Intervention/treatment||Phase|
|Severe Sepsis||Other: Describe for the first time the kinetics of evolution in proportion of the circulating Brég in patients with severe septic state, at times D0, D2, D7 and D14 of hospitalization in medical reanimation.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Descriptive Study of the Evolution in Proportion of Regulatory B Lymphocytes in Patients Hospitalized in Intensive Care for Severe Sepsis|
|Actual Study Start Date :||April 20, 2016|
|Estimated Primary Completion Date :||May 19, 2017|
|Estimated Study Completion Date :||May 19, 2017|
|Adult patients with severe sepsis||
Other: Describe for the first time the kinetics of evolution in proportion of the circulating Brég in patients with severe septic state, at times D0, D2, D7 and D14 of hospitalization in medical reanimation.
Describe for the first time the kinetics of evolution in proportion of the circulating Brég in patients with severe septic state, at times D0, D2, D7 and D14 (or on leaving the service if before D14) of hospitalization in medical reanimation.
- Variation in the proportion of circulating Breg compared to total B lymphocytes in the included cohort of patients [ Time Frame: 28 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115125
|Contact: Jean-Pierre MAROLLEAU, PhDfirstname.lastname@example.org|
|CHU Amiens Picardie||Recruiting|
|Amiens, Picardie, France, 80054|
|Contact: Jean-Pierre MAROLLEAU, PhD +33322455914 email@example.com|