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

NCT06440317 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-01-15

No results posted yet for this 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.

Conditions

Interventions

DEVICE

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

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.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Maria MAMANI, Pr · ImmunoConcEpT, Bordeaux University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2027-05-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06440317 on ClinicalTrials.gov