A Multiple Centre, Cohort Study of New CRRT Membranes oXiris for Patients With Septic Shock
- Conditions
- Acute Kidney Injury Due to Sepsis (Disorder)
- Interventions
- Device: Continuous renal replacement therapy with oXiris
- Registration Number
- NCT04073771
- Lead Sponsor
- Southeast University, China
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 590
- >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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort study Continuous renal replacement therapy with oXiris Patients with septic shock undergoing continuous renal replacement therapy
- Primary Outcome Measures
Name Time Method 28-day mortality 28 days 28-day mortality
The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours 72 hours after Continuous Renal Replacement Therapy initiation The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours(Scores Range 0-4, higher values represent a worse outcome)
- Secondary Outcome Measures
Name Time Method Changes of Sepsis-related Organ Failure Assessment(SOFA) Score 72 hours after Continuous Renal Replacement Therapy initiation Changes from baseline to 72 hours in Sepsis-related Organ Failure Assessment(SOFA) Score
Total length of Continuous Renal Replacement Therapy Day 28 Total length of Continuous Renal Replacement Therapy to day 28
mechanical ventilation free days Day 28 Total length of mechanical ventilation free days up to to day 28
VIS-Norepinephrine dose or equivalent 72 hours after Continuous Renal Replacement Therapy initiation Norepinephrine dose or equivalent at 72 hours after Continuous Renal Replacement Therapy initiation
Lactate concentration at 72 hours 72 hours after Continuous Renal Replacement Therapy initiation Lactate concentration level at 72 hours after Continuous Renal Replacement Therapy initiation initiation
Change of Norepinephrine dose Over Time 72 hours after Continuous Renal Replacement Therapy initiation Difference of Norepinephrine dose at 72 hours compared with Continuous Renal Replacement Therapy initiation
Vasopressor-free days Day 28 Vasopressor-free days to day 28
ICU mortality through study completion, an average of 1 month All cause mortality in ICU
Trial Locations
- Locations (2)
Zhongda Hospital, Southeast University
🇨🇳Nanjing, Jiangsu, China
Department of Nephrology, Sichuan University West ChinaHospital
🇨🇳Chengdu, Sichuan, China