Acute Kidney InjuryNCT04952714
RRT With a Cytokine Absorption Filter (oXiris ®) in Patients With Septic Shock
An observational study of Acute Kidney Injury and Septic Shock, run by Clinica CES at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Septic Shock
- What is being tested?
- Oxiris
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 1 siteColombia
- Study dates
- 1 Sep 2021to 10 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the institutional Intensive Care Unit (CES Clinic) with acute kidney injury induced by sepsis and requiring renal replacement therapy.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Oxiris
- Keywords
- Renal Replacement Therapy
- Medical subject headings
- Acute Kidney Injury, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxirisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Oxiris |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Demographic variables such as age (years), gender, body mass index (Kg / Mt2) and previous comorbid pathologies will be taken from the electronic medical record.
Measured: 28 days
Cardiovascular status: Lactate
Changes from baseline Lactate (mmol/L) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
Measured: 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
Changes from baseline pH measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
Measured: 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
Changes from baseline IL-6 (pg/mL) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
Measured: 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
Changes from baseline Procalcitonin (ng/mL) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
Measured: 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
Changes from baseline C-Reactive Protein (mg/dL) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
Measured: 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.
The parameters used in renal replacement therapy (anticoagulation, duration and time to start in days) will be taken from the electronic medical record.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Sep 2021
- Primary completion1 Jun 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica CES
- Sponsor type
- Research network
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- David Yepes-Gómez, MD, MSc, Principal investigator, Clinica CES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952714
- Sponsor's protocol ID
- Acta240Proy010
- Status last verified
- Feb 2024
- First submitted
- 11 Apr 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Replacement Therapy With a Cytokine Absorption Filter (oXiris ®) in Patients With Septic Shock: a Case-control Study Nested in a Cohort
- ClinicalTrials.gov ID
- NCT04952714
- Acronym / sponsor ID
- Acta240Proy010
- Conditions
- Acute Kidney Injury, Septic Shock
- Keywords
- Renal Replacement Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Clinica CESResearch network
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic Cohort | – | Device: OxirisInitially, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the institutional Intensive Care Unit (CES Clinic) with acute kidney injury induced by sepsis and requiring renal replacement therapy.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxirisThrough 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. | Device | Dynamic Cohort |
Primary outcome
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).
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).
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).
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).
7 secondary outcomes
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
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Yepes-Gómez, MD, MSc principal investigator
Clinica CES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Septic Shock, run by Clinica CES at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.