NCT04952714

RRT With a Cytokine Absorption Filter (oXiris ®) in Patients With Septic Shock

Renal Replacement Therapy With a Cytokine Absorption Filter (oXiris ®) in Patients With Septic Shock: a Case-control Study Nested in a Cohort

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Clinica CES · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acute kidney injury (AKI) is a common complication in critically ill patients. Multiple studies have reported evidence that the main cause of ARF is sepsis, as part of the Multiple Organ Dysfunction Syndrome: up to 50% of septic patients develop acute renal failure. RRT continues to be the standard management for severe acute renal failure, especially in its continuous modality and applied to the septic patient, generally with hemodynamic instability. The presence of SA-AKI (sepsis-associated acute kidney injury) is associated with short-term and long-term adverse events, which include: prolonged hospital stay, the development of chronic kidney disease (CKD), increased cardiovascular risk and increased risk of death. Its presence is even considered a factor with an independent association with mortality and has a higher fatality rate than ARF developed by another etiology. Different clinical studies have been developed based on the addition of hemoadsorption membranes to RRT that, although they have not shown significant differences in the reduction of mortality, have impacted secondary outcomes such as the reduction of pro-inflammatory cytokines, decrease in vasopressor support requirements, decrease in serum lactate, significant improvement in the SOFA score, improvement in oxygenation indices and decrease in hospital stay. These benefits are presented without reports of adverse events associated with its use. The oXiris® filter was recently developed: a single high permeability membrane capable of removing cytokines and endotoxins during renal support with the addition of antithrombotic properties. The experience of its use is limited to in vitro studies, case reports, retrospective cohorts and an RCT that provide consistent evidence of its benefits. A longitudinal, bi-directional, observational analytical study is proposed. A case-control study nested in a dynamic cohort will be developed to determine the effect of the use of hemofiltration with a cytokine removal filter (oXiris®) on the decrease in mortality at 28 days of patients with acute kidney injury induced by sepsis. (SA-AKI), as well as the dose of vasopressor support, oxygenation parameters and inflammatory markers.

Conditions

• Acute Kidney Injury
• Septic Shock

Interventions

Type	Name	Description
DEVICE	Oxiris	Through a previously established and standardized management protocol, the treating team will prescribe renal replacement therapy by hemodiafiltration (CVVHDF) in the PrismaFlex device, at a dose of 25 mL / Kg of PrismaSate dialysis solutio and the removal filter oXiris® cytokines (Baxter) vs. the standard filter.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-06-01
• Completion: 2023-11-10
• First posted: 2021-07-07
• Last updated: 2024-02-07

Locations

1 site across 1 country: Colombia