A Multiple Centre, Cohort Study of New CRRT Membranes oXiris for Patients With Septic Shock

Southeast University, China

Status: Completed

Conditions: Acute Kidney Injury Due to Sepsis (Disorder)

Treatments: Device: Continuous renal replacement therapy with oXiris

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04073771

2018ZDSYLL152-P01

18CECACAP1004 (Other Grant/Funding Number)

Details and patient eligibility

About

The objectives of this study are to determine whether Continuous Renal Replacement Therapy (CRRT) with oXiris in patients with septic shock would improve clinical outcomes such as the sepsis-related organ failure assessment (SOFA) , hemodynamic, mortality compared CRRT with conventional membrane.

Full description

Sepsis is the leading cause of death in ICU, resulting in multi-organ failure in critically ill patients. Patients with septic shock combined sepsis-associated Acute kidney injury (AKI)have even poorer outcome.

Endotoxin activity, inflammation and immune dysfunction, have been consider relevant to their pathogenesis of sepsis. High levels of Inflammation are associated with worse clinical outcomes. However, all studies of anti-inflammation treatment in sepsis patient are failed and anti-inflammation treatment of sepsis still remains controversial.

oXiris is a new filter with adsorptive membrane, which removes endotoxin and inflammatory mediator from plasma. But current evidence of oXiris is limited, and only some small sample studies have proved that it can improve the haemodynamics and the sepsis-related organ failure assessment(SOFA) score.

Our hypothesis was that oXiris would be associated with better clinical outcomes, such as decreased SOFA score, improved survival rate, better hemodynamic, and improved of organ function.

Enrollment: 590 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 Years
• Treated by CRRT using oXiris or conventional membrane
• SOFA cardiovascular Score ≥ 3
• Septic shock due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection)
• Written informed consent

Exclusion criteria

• Chronic Kidney Disease
• Renal replacement therapy (RRT) in the last 30 days
• Pregnancy
• Immunosuppressive treatment or steroids (prednisone > 0.5 mg/kg/day or equivalent).
• Autoimmune disorder.
• Transplant receptor.
• Inclusion in other ongoing studies within the last 30 days.
• Coexisting illness with a high probability of death

Trial design

590 participants in 1 patient group

Cohort study

Description:

Patients with septic shock undergoing continuous renal replacement therapy

Treatment:

Device: Continuous renal replacement therapy with oXiris