Status:
COMPLETED
Systems Analysis of Antigen Presenting Cells in Human Sepsis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Sepsis
Acute Circulatory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 affect...
Eligibility Criteria
Inclusion
- 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.
- 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
Exclusion
- 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,
- 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
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2022
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03788772
Start Date
July 15 2019
End Date
August 24 2022
Last Update
September 12 2025
Active Locations (1)
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1
Cochin Hospital, AP-HP
Paris, France, 75014