Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane

Phase

N/A

Condition

Soft Tissue Infections

Treatment

Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane)

Clinical Study ID

NCT06440317

CHUBX 2023/93

Ages > 18
All Genders

Study Summary

Sepsis remains a global scourge. Before the SARS-CoV-2 pandemic, the World Health Organization estimated approximately 49 million cases annually, resulting in 11 million deaths. Defined by dysregulated host response to infection, sepsis leads to vital organ failure. Renal dysfunction affects about half of ICU patients, necessitating extracorporeal renal replacement therapy in approximately 10% of cases, alongside coagulation system involvement typified by thrombocytopenia. Immunothrombotic phenomena are pivotal in sepsis pathophysiology, activating coagulation and disrupting immune responses. Microcirculatory impairment, mediated by neutrophils, monocytes, and platelets, worsens vital organ perfusion. Excessive production of Neutrophil Extracellular Traps (NETs) is implicated in microcirculatory compromise during sepsis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients aged 18 years and older
Admitted to the intensive care unit with septic shock, defined as an increase in theSequential Organ Failure Assessment (SOFA) score of at least 2 points due toinfection, requiring vasopressor drugs to maintain a mean arterial pressure (MAP) ≥ 65 mmHg, and a lactate level > 2 mmol/L (18 mg/dL) despite adequate fluidresuscitation
Requiring renal replacement therapy according to consensus indications:
KDIGO stage 3 acute kidney injury with oliguria or anuria persisting for morethan 72 hours
Urea > 40 mmol/L
Plasma potassium > 5.5 mmol/L despite medical treatment
pH < 7.15 (pure metabolic acidosis with PaCO2 < 30 mmHg or mixed acidosis withPaCO2 > 50 mmHg without the possibility of improving alveolar ventilation)
Acute pulmonary edema secondary to hydrosaline overload resulting in severehypoxemia (oxygen flow > 5 L/min or FiO2 > 50% during mechanical ventilation tomaintain SaO2 > 95%) despite diuretic therapy
Receiving continuous renal replacement therapy with a high-adsorption membrane (oXiris membrane) or a conventional membrane (HF1400 membrane)

Exclusion

Exclusion Criteria:

Known history of constitutional thrombopathy (Bernard Soulier disease, Glanzmannthrombasthenia, Gray's syndrome or dense granule disease)
Myelodysplastic or myeloproliferative syndrome
Autoimmune thrombocytopenic purpura
Acute leukemia
Hemorrhagic shock
Platelet transfusion within 7 days prior to inclusion
Antiplatelet therapy with clopidogrel or ticagrelor within 5 days prior toinclusion, prasugrel or dipyridamole within 7 days prior to inclusion
Active HIV infection or hepatitis B or C
Pregnant woman
Not affiliated to a social security system or not benefiting from such a system

Study Design