A Multiple Centre, Cohort Study of New Continuous Renal Replacement Therapy (CRRT) Membranes oXiris for Patients With Septic Shock
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 590
- Locations
- 2
- Primary Endpoint
- 28-day mortality
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
28-day mortality
Time Frame: 28 days
28-day mortality
The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours
Time Frame: 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 Outcomes
- Changes of Sepsis-related Organ Failure Assessment(SOFA) Score(72 hours after Continuous Renal Replacement Therapy initiation)
- Total length of Continuous Renal Replacement Therapy(Day 28)
- VIS-Norepinephrine dose or equivalent(72 hours after Continuous Renal Replacement Therapy initiation)
- Lactate concentration at 72 hours(72 hours after Continuous Renal Replacement Therapy initiation)
- mechanical ventilation free days(Day 28)
- Change of Norepinephrine dose Over Time(72 hours after Continuous Renal Replacement Therapy initiation)
- Vasopressor-free days(Day 28)
- ICU mortality(through study completion, an average of 1 month)
Investigators
Songqiao Liu
Prof.
Southeast University, China