Clinical trial NCT04073771: A Multiple Centre, Cohort Study of New CRRT Membranes oXiris for Patients With Septic Shock
Official title: A Multiple Centre, Cohort Study of New Continuous Renal Replacement Therapy (CRRT) Membranes oXiris for Patients With Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury Due to Sepsis (Disorder)
Keywords: Septic shock, AKI, CRRT
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2019-08-29
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Septic shock patients due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection) treated by 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.

Eligibility criteria: 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

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
measure: The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours
timeFrame: 72 hours after Continuous Renal Replacement Therapy initiation
Secondary outcomes:
measure: Changes of Sepsis-related Organ Failure Assessment(SOFA) Score
timeFrame: 72 hours after Continuous Renal Replacement Therapy initiation
measure: VIS-Norepinephrine dose or equivalent
timeFrame: 72 hours after Continuous Renal Replacement Therapy initiation
measure: Change of Norepinephrine dose Over Time
timeFrame: 72 hours after Continuous Renal Replacement Therapy initiation
measure: Vasopressor-free days
timeFrame: Day 28
measure: Lactate concentration at 72 hours
timeFrame: 72 hours after Continuous Renal Replacement Therapy initiation
measure: ICU mortality
timeFrame: through study completion, an average of 1 month
measure: mechanical ventilation free days
timeFrame: Day 28
measure: Total length of Continuous Renal Replacement Therapy
timeFrame: Day 28
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
city: Chengdu
country: China
facility: Department of Nephrology, Sichuan University West ChinaHospital
state: Sichuan
Study officials:
References:
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