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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxiris Group | Patients with septic shock requiring renal replacement therapy treated with the Oxiris filter. |
| |
| Standard Filter Group | Patients with septic shock requiring renal replacement therapy treated with standard hemofilters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxiris filter | Device | Hemofilter used for renal replacement therapy with cytokine and endotoxin adsorption properties. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28-day all-cause mortality | All-cause mortality within 28 days from the initiation of renal replacement therapy. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| ICU length of stay | Length of stay in the intensive care unit measured in days. | From ICU admission to ICU discharge, assessed up to 28 days |
| Renal recovery | Recovery of kidney function defined as independence from renal replacement therapy at discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill adult patients admitted to an intensive care unit with septic shock and acute kidney injury requiring renal replacement therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClĂnica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| Standard Hemofilter | Device | 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. |
|
| Assessed at hospital discharge, up to 90 days |
| Duration of renal replacement therapy | Total duration of renal replacement therapy during ICU stay, measured in days. | From initiation to discontinuation of RRT, assessed up to 28 days |
| In-hospital mortality | All-cause mortality during hospital stay. | From hospital admission to discharge, assessed up to 90 days |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |