Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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

Inclusion Criteria:

  • Patients aged 18 years and older
  • Admitted to the intensive care unit with septic shock, defined as an increase in the Sequential Organ Failure Assessment (SOFA) score of at least 2 points due to infection, requiring vasopressor drugs to maintain a mean arterial pressure (MAP) ≥ 65 mmHg, and a lactate level > 2 mmol/L (18 mg/dL) despite adequate fluid resuscitation
  • Requiring renal replacement therapy according to consensus indications:
    • KDIGO stage 3 acute kidney injury with oliguria or anuria persisting for more than 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 with PaCO2 > 50 mmHg without the possibility of improving alveolar ventilation)
    • Acute pulmonary edema secondary to hydrosaline overload resulting in severe hypoxemia (oxygen flow > 5 L/min or FiO2 > 50% during mechanical ventilation to maintain SaO2 > 95%) despite diuretic therapy
  • Receiving continuous renal replacement therapy with a high-adsorption membrane

    (oXiris membrane) or a conventional membrane (HF1400 membrane)

Exclusion Criteria:

  • Known history of constitutional thrombopathy (Bernard Soulier disease, Glanzmann thrombasthenia, 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 to inclusion, 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 details
    Sepsis

NCT06440317

University Hospital, Bordeaux

8 September 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.