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

Sponsor
University Hospital, Bordeaux
Study ID
NCT06440317
Status
Recruiting
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Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane) — DEVICE
    The PRISMAFLEX® or PRISMAX® control unit (pre- and post-dilution with a prescribed treatment dose \> 25 ml/kg/h) with regional citrate anticoagulation and a substitution solution by PHOXILLUM will be used regardless of the type of membrane used (the oXiris membrane and the HF 1400 membrane), also as part of routine care provided in the ICU.

Study Details

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.

Key Dates

First listed
Jun 3, 2024
Start date
Apr 30, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Hemofiltration membranes (the oXiris® membrane and the HF1400 ® membrane)
    Eligible patients for this study will undergo renal replacement therapy using two hemofiltration membranes commonly used in intensive care units.

Primary Outcome Measure

Immunothrombosis : Concentration of platelet activation markers [ Time Frame: 12 months after inclusion day ]

Central Contacts

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