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

NCT04952714 | Completed

• 1 other identifier: Acta240Proy010
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Renal Replacement Therapy

Outcome Measures

Primary Outcomes (4)

• Mortality

  Effect of the use of hemofiltration with a cytokine removal filter (oXiris®) in the reduction in mortality at 28 days of patients with acute kidney injury induced by sepsis (SA-AKI).

  28 days

• Cardiovascular support

  Effect of using hemofiltration with a cytokine removal filter (oXiris®) in reducing the dose of vasopressor support (mcg/g/min) in patients with acute kidney injury induced by sepsis (SA-AKI).

  Every 24 hours, from date of admission to the Intensive Care Unit until discharge from the ICU or death from any cause, whichever came first. Assessed up to 2 weeks.

• Pulmonary support

  Effect of using hemofiltration with a cytokine removal filter (oXiris®) in improving the oxygenation parameters (PaO2/FiO2) in patients with acute kidney injury induced by sepsis (SA-AKI).

  Every 24 hours, from date of admission to the Intensive Care Unit until discharge from the ICU or death from any cause, whichever came first. Assessed up to 2 weeks.

• Inflammatory markers

  Effect of using hemofiltration with a cytokine removal filter (oXiris®) in reducing inflammatory markers (CRP, Procalcitonin, IL-6) in patients with sepsis-induced acute kidney injury (SA-AKI).

  Every 48 hours, from date of admission to the Intensive Care Unit until discharge from the ICU or death from any cause, whichever came first. Assessed up to 2 weeks.

Secondary Outcomes (7)

• Demographic characteristics of patients with sepsis-induced acute kidney injury (SA-AKI) on renal replacement therapy treated in the Intensive Care Unit of the CES Clinic.

  28 days

• Cardiovascular status: Lactate

  Every 24 hours, from date of admission to the Intensive Care Unit until discharge from the ICU or death from any cause, whichever came first. Assessed up to 2 weeks.

• Cardiovascular status: pH

  Every 24 hours, from date of admission to the Intensive Care Unit until discharge from the ICU or death from any cause, whichever came first. Assessed up to 2 weeks.

• Inflammatory status: IL-6

  Every 48 hours, from date of admission to the Intensive Care Unit until discharge from the ICU or death from any cause, whichever came first. Assessed up to 2 weeks.

• Inflammatory status: Procalcitonin

  Every 48 hours, from date of admission to the Intensive Care Unit until discharge from the ICU or death from any cause, whichever came first. Assessed up to 2 weeks.

Study Arms (1)

Dynamic Cohort

Initially, participants who meet the inclusion criteria will be recruited to assemble a cohort of patients with sepsis and those who develop sepsis-induced acute kidney injury will be observed. Through a previously established and standardized management protocol, the treating team will prescribe renal replacement therapy by hemodiafiltration (CVVHDF) in the PrismaFlex device (Baxter), at a dose of 25 mL / Kg of PrismaSate dialysis solution (Baxter) and the removal filter oXiris® cytokines (Baxter) vs. the standard filter, for patients who require it, in the presence of a confirmed diagnosis of acute renal failure. Hemodynamic and ventilatory parameters will be monitored every 24 hours, and inflammatory parameters every 48 hours. A follow-up will be done at 28 days to establish mortality.

Device: Oxiris

Interventions

Oxiris DEVICE

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.

Dynamic Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the institutional Intensive Care Unit (CES Clinic) with acute kidney injury induced by sepsis and requiring renal replacement therapy.

You may qualify if:

• Patients who enter the Intensive Care Unit of the CES Clinic during the recruitment period with:
• Diagnosis of septic shock of any origin according to the definition of the Sepsis-3 consensus.
• Acute renal injury according to the KDIGO 2012 classification that requires continuous renal replacement therapy and that its origin is presumed to be septic origin.
• In invasive ventilatory support.
• Informed consent previously filled out by a guardian.

You may not qualify if:

• Patients under 18 years of age and women in pregnancy or postpartum will be excluded.
• Chronic kidney disease that requires RRT on an outpatient basis before admission to the ICU.
• Contraindication to the use of heparins or another anticoagulant
• Dissent to escalate therapeutic measures
• Terminal or irrecoverable condition according to the criteria of the specialist in critical medicine and intensive care

Sponsors & Collaborators

• Clinica CES: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Clinica CES

Medellín, Antioquia, 050012, Colombia

Location

MeSH Terms

Conditions

Acute Kidney Injury; Shock, Septic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• David Yepes-Gómez, MD, MSc

  Clinica CES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: July 7, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: November 10, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)