NCT04073771

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

A Multiple Centre, Cohort Study of New Continuous Renal Replacement Therapy (CRRT) Membranes oXiris for Patients With Septic Shock

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 590 (actual)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Acute Kidney Injury Due to Sepsis (Disorder)

Interventions

Type	Name	Description
DEVICE	Continuous renal replacement therapy with oXiris	Continuous renal replacement therapy with oXiris in patient with septic shock

Timeline

• Start date: 2019-09-21
• Primary completion: 2021-06-30
• Completion: 2021-10-31
• First posted: 2019-08-29
• Last updated: 2022-12-02

Locations

2 sites across 1 country: China