Acute Kidney Injury, Septic Shock
Conditions
Keywords
Oxiris, Renal Replacement Therapy, Continuous Renal Replacement Therapy, Hemofilter, Cytokine Adsorption, Endotoxin Removal, Intensive Care Unit
Brief summary
Sepsis and septic shock are major causes of mortality in critically ill patients and are frequently associated with acute kidney injury requiring renal replacement therapy. The Oxiris filter is a hemofilter designed to provide both renal support and adsorption of endotoxins and inflammatory mediators. This study aims to evaluate the association between the use of the Oxiris filter and clinical outcomes in critically ill patients with septic shock requiring renal replacement therapy. A retrospective cohort design will be used, including patients admitted to an intensive care unit who received renal replacement therapy. Outcomes such as mortality and renal function will be analyzed and compared between patients treated with Oxiris and those treated with other filters.
Detailed description
Sepsis and septic shock are leading causes of morbidity and mortality in critically ill patients and are commonly associated with acute kidney injury requiring renal replacement therapy (RRT). Extracorporeal blood purification techniques have been proposed as an adjunctive therapy to modulate the host inflammatory response. The Oxiris filter is a modified AN69-based membrane designed to provide renal support while simultaneously adsorbing endotoxins and cytokines. This retrospective cohort study aims to assess the impact of Oxiris filter use on clinical outcomes in patients with septic shock requiring RRT. The study will include adult patients admitted to an intensive care unit over a defined study period who required RRT due to acute kidney injury in the context of septic shock. Patients will be categorized according to the type of hemofilter used (Oxiris versus standard filters). The primary outcome will be mortality within a defined follow-up period. Secondary outcomes will include renal recovery, duration of renal replacement therapy, and length of stay in the intensive care unit. Statistical analyses will be performed to compare outcomes between groups and adjust for potential confounding factors. Appropriate multivariable models will be used to evaluate the association between Oxiris use and clinical outcomes. Given the retrospective nature of the study, no interventions will be assigned, and all treatments will have been administered according to routine clinical practice.
Interventions
DEVICEOxiris filter
Hemofilter used for renal replacement therapy with cytokine and endotoxin adsorption properties.
DEVICEStandard Hemofilter
Standard hemofilters used for continuous renal replacement therapy without specific adsorption properties for endotoxins or cytokines. These filters provide conventional renal support and are used according to routine clinical practice.
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years old) * Admission to the intensive care unit * Diagnosis of septic shock * Requirement of renal replacement therapy due to acute kidney injury * Treatment with either Oxiris filter or standard hemofilters
Exclusion criteria
* Patients under 18 years of age * Chronic dialysis prior to ICU admission * Missing key clinical data * Patients not meeting criteria for septic shock
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day all-cause mortality | Up to 28 days | All-cause mortality within 28 days from the initiation of renal replacement therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU length of stay | From ICU admission to ICU discharge, assessed up to 28 days | Length of stay in the intensive care unit measured in days. |
| Renal recovery | Assessed at hospital discharge, up to 90 days | Recovery of kidney function defined as independence from renal replacement therapy at discharge. |
| Duration of renal replacement therapy | From initiation to discontinuation of RRT, assessed up to 28 days | Total duration of renal replacement therapy during ICU stay, measured in days. |
| In-hospital mortality | From hospital admission to discharge, assessed up to 90 days | All-cause mortality during hospital stay. |
Countries
Spain
Outcome results
None listed