An observational study in Acute Kidney Injury and Septic Shock, sponsored by Clinica CES. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Clinica CES · Observational
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 93 is close to the median of 100 across 298 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →This is the only study on the registry with Clinica CES as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients admitted to the institutional Intensive Care Unit (CES Clinic) with acute kidney injury induced by sepsis and requiring renal replacement therapy.
Exclusion Criteria:
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.
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).
Time frame: 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).
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.
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).
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 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).
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.
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.
Time frame: 28 days
Cardiovascular status: Lactate
Changes from baseline Lactate (mmol/L) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
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
Changes from baseline pH measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
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
Changes from baseline IL-6 (pg/mL) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
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
Changes from baseline Procalcitonin (ng/mL) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
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
Changes from baseline C-Reactive Protein (mg/dL) measurements with the cytokine removal filter (oXiris®) vs. the standard filter.
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.
The parameters used in renal replacement therapy (anticoagulation, duration and time to start in days) will be taken from the electronic medical record.
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.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.