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

February 5, 2024 updated by: Clinica CES

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050012
        • Clinica Ces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 28 days
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 28 days
Demographic variables such as age (years), gender, body mass index (Kg / Mt2) and previous comorbid pathologies will be taken from the electronic medical record.
28 days
Cardiovascular status: Lactate
Time Frame: 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.
Changes from baseline Lactate (mmol/L) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
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
Time Frame: 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.
Changes from baseline pH measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
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
Time Frame: 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.
Changes from baseline IL-6 (pg/mL) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
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
Time Frame: 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.
Changes from baseline Procalcitonin (ng/mL) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
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: CRP
Time Frame: 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.
Changes from baseline C-Reactive Protein (mg/dL) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
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.
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.
Time Frame: 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.
The parameters used in renal replacement therapy (anticoagulation, duration and time to start in days) will be taken from the electronic medical record.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica CES

Collaborators

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: David Yepes-Gómez, MD, MSc, Clinica Ces

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

April 11, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acta240Proy010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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