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Recruiting NCT06440317

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

— Observational Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane).
Who it may be relevant to
Registry conditions: Sepsis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

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.

Primary outcome measures

  • Immunothrombosis : Concentration of platelet activation markers [Time frame: 12 months after inclusion day]
Secondary outcome measures (2)
  • NETosis : Concentration of Neutrophil Extracellular Traps [Time frame: 12 months after inclusion day]
  • Monocyte activation : Concentration of monocyte (CD14+) [Time frame: 12 months after inclusion day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hopital Haut-Lévêque — Pessac

Identifiers

NCT: NCT06440317 · CHUBX 2023/93

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗