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NCT Number: NCT04952714

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica CES

Medellín, Antioquia, 050012, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Clinica CES

Network

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2021
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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