Clinical trial NCT04952714: RRT With a Cytokine Absorption Filter (oXiris ®) in Patients With Septic Shock
Official title: Renal Replacement Therapy With a Cytokine Absorption Filter (oXiris ®) in Patients With Septic Shock: a Case-control Study Nested in a Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Septic Shock
Keywords: Renal Replacement Therapy
Lead sponsor: Clinica CES
Sponsor class: NETWORK
Collaborators: name: Baxter Healthcare Corporation
First posted: 2021-07-07
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mortality
timeFrame: 28 days
measure: Cardiovascular support
timeFrame: 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.
measure: Pulmonary support
timeFrame: 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.
measure: Inflammatory markers
timeFrame: 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:
measure: 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.
timeFrame: 28 days
measure: Cardiovascular status: Lactate
timeFrame: 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.
measure: Cardiovascular status: pH
timeFrame: 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.
measure: Inflammatory status: IL-6
timeFrame: 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.
measure: Inflammatory status: Procalcitonin
timeFrame: 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.
measure: Inflammatory status: CRP
timeFrame: 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.
measure: Describe the treatment 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.
timeFrame: 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.
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Clinica CES
state: Antioquia
Study officials:
affiliation: Clinica CES
name: David Yepes-Gómez, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: