Descriptive Study of the Evolution in Proportion of Regulatory B Lymphocytes in Patients Hospitalized in Intensive Care for Severe Sepsis

Severe Sepsis Clinical Trial

— DELyBREG  

Official title:

Descriptive Study of the Evolution in Proportion of Regulatory B Lymphocytes in Patients Hospitalized in Intensive Care for Severe Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03115125
• Other study ID #: PI2015_843_0028
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2017
• Last updated: April 10, 2017
• Start date: April 20, 2016
• Est. completion date: May 19, 2017

Study information

• Verified date: April 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Jean-Pierre MAROLLEAU, PhD
• Phone: +33322455914
• Email: marolleau.jean-pierre[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 19, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with severe sepsis or septic shock diagnosed less than 24 hours (defined as D0) and hospitalized in the medical resuscitation department of the Amiens-Picardie University Hospital.

• The definitions of severe sepsis and septic shock are the result of the consensus of the Société de Réanimation de Langue Française dating from 2005:

• Sepsis refers to a systemic inflammatory response syndrome (SIRS) in the presence of suspected or identified infection. Sepsis is said to be severe when lactate> 4 mmol / L or arterial hypotension prior to filling or organ dysfunction is present (one is sufficient): hypoxemia with a PaO2 / FIO2 <300 ratio, renal failure with Hepatic insufficiency with INR> 4 or bilirubin> 78 µmol / l, thrombocytopenia (platelets <100 000 / mm3) and hepatic insufficiency> 176 µmol / l, coagulation disorders with INR> 1.5 Disorders of higher functions with a Glasgow Coma Score <13.

• Finally, septic shock is defined as a severe sepsis condition with persistent hypotension despite a well-conducted vascular filling (20-40 ml / kg isotonic saline).

Exclusion Criteria:

• Patient with active neoplasia, immune deficiency, autoimmune disease or autoimmune disease.

• Patient under tutorship or curatorship

• Taking an immunomodulatory or immunosuppressive treatment at the time of the study or the year prior to hospitalization for sepsis.

• Antecedent or haematopoietic graft in progress.

• Pregnancy in progress.

• Known history of infection with human immunodeficiency virus (HIV) type 1 or 2 or with hepatitis B or C virus

• Patient with agranulocytosis (defined as neutrophils <0.5 G / L).

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation in the proportion of circulating Breg compared to total B lymphocytes in the included cohort of patients		28 days