Sepsis immune cell study ends early
NCT ID NCT03115125
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looked at a type of immune cell called regulatory B lymphocytes in 10 patients with severe sepsis in the intensive care unit. The goal was to track how these cells change over time after infection. The study was terminated early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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Apr 2016
- Finished
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Aug 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Amiens Picardie
Amiens, Picardie, 80054, France
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Other studies related to the condition(s) this trial covers.
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