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

NCT06440317 | Recruiting

• 1 other identifier: CHUBX 2023/93
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Sepsis

Keywords

Intensive Care; Immunothrombosis; NETs; Neutrophils; Platelets

Outcome Measures

Primary Outcomes (1)

• Immunothrombosis : Concentration of platelet activation markers

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

  12 months after inclusion day

Secondary Outcomes (2)

• NETosis : Concentration of Neutrophil Extracellular Traps

  12 months after inclusion day

• Monocyte activation : Concentration of monocyte (CD14+)

  12 months after inclusion day

Study Arms (1)

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients for this study will undergo renal replacement therapy using two hemofiltration membranes commonly used in intensive care units

You may qualify if:

• 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)

You may not qualify if:

• 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
• Active HIV infection or hepatitis B or C
• Pregnant woman
• Not affiliated to a social security system or not benefiting from such a system

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Hopital Haut-Lévêque

Pessac, 33604, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected in citrate and EDTA tubes before and after the membrane on the day of initiating renal replacement therapy (Day 0), the day after starting therapy (Day 1), and 5 days after (Day 5). Extraction of peripheral blood mononuclear cells (PBMCs) will be done.

MeSH Terms

Conditions

Sepsis; Thromboinflammation

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Maria MAMANI, Pr

  ImmunoConcEpT, Bordeaux University

  STUDY CHAIR

Central Study Contacts

Antoine DEWITTE, Dr

CONTACT

05 57 65 68 66; antoine.dewitte@u-bordeaux.fr

Sarah CRONIER

CONTACT

05 57 65 68 66; sara.cronier@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: June 3, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)