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NCT Number: NCT06440317

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Immunothrombosis : Concentration of platelet activation markers

    Time frame: 12 months after inclusion day

    Dosages of platelet activation markers, before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane

Secondary outcomes

  1. NETosis : Concentration of Neutrophil Extracellular Traps

    Time frame: 12 months after inclusion day

    Dosages of Neutrophil Extracellular Traps, before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane

  2. Monocyte activation : Concentration of monocyte (CD14+)

    Time frame: 12 months after inclusion day

    Dosages of monocyte (CD14+), before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine DEWITTE, Dr

CONTACT

[email protected]

05 57 65 68 66 ext. +33

Sarah CRONIER

CONTACT

[email protected]

05 57 65 68 66 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

Investigation of Immunothrombosis in Intensive Care Patients With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane

Acronym: PLAQSIRIS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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