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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Hopital Haut-Lévêque
RECRUITING
Pessac
Contact Information
Primary
Antoine DEWITTE, Dr
antoine.dewitte@u-bordeaux.fr
05 57 65 68 66
Backup
Sarah CRONIER
sara.cronier@chu-bordeaux.fr
05 57 65 68 66
Time Frame
Start Date: 2025-01
Estimated Completion Date: 2026-02
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux
Collaborators: Baxter Healthcare Corporation

This content was sourced from clinicaltrials.gov