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

NCT ID: NCT06440317

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-02-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria MAMANI, Pr

Role: STUDY_CHAIR

ImmunoConcEpT, Bordeaux University

Locations

Hopital Haut-Lévêque

Pessac, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Antoine DEWITTE, Dr

Role: CONTACT

Phone: 05 57 65 68 66

Email: antoine.dewitte@u-bordeaux.fr

Sarah CRONIER

Role: CONTACT

Phone: 05 57 65 68 66

Email: sara.cronier@chu-bordeaux.fr

Facility Contacts

Antoine DEWITTE, Dr

Role: primary

Sarah CRONIER

Role: backup

Other Identifiers

CHUBX 2023/93

Identifier Type: -

Identifier Source: org_study_id