Acute Kidney Injury Due to Sepsis (Disorder)
Conditions
Keywords
Septic shock, AKI, CRRT
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.
Interventions
DEVICEContinuous renal replacement therapy with oXiris
Continuous renal replacement therapy with oXiris in patient with septic shock
Sponsors
Baxter Healthcare Corporation
Southeast University, China
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| mechanical ventilation free days | Day 28 | Total length of mechanical ventilation free days up to to day 28 |
| Total length of Continuous Renal Replacement Therapy | Day 28 | Total length of Continuous Renal Replacement Therapy to day 28 |
| ICU mortality | through study completion, an average of 1 month | All cause mortality in ICU |
| 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 |
Countries
China
Outcome results
None listed