Use of Oxiris Filter in Septic Shock Patients Requiring Renal Replacement Therapy: A Retrospective Cohort Study
Impact of Oxiris Filter Use on Mortality and Renal Outcomes in Critically Ill Patients With Septic Shock Requiring Renal Replacement Therapy: A Retrospective Cohort Study
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Navarre
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Pamplona、Navarre、西班牙、31008
- Clinica Universidad de Navarra
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Oxiris Group
Patients with septic shock requiring renal replacement therapy treated with the Oxiris filter.
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Hemofilter used for renal replacement therapy with cytokine and endotoxin adsorption properties.
|
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Standard Filter Group
Patients with septic shock requiring renal replacement therapy treated with standard hemofilters.
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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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
28-day all-cause mortality
大体时间:Up to 28 days
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All-cause mortality within 28 days from the initiation of renal replacement therapy.
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Up to 28 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ICU length of stay
大体时间:From ICU admission to ICU discharge, assessed up to 28 days
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Length of stay in the intensive care unit measured in days.
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From ICU admission to ICU discharge, assessed up to 28 days
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Renal recovery
大体时间:Assessed at hospital discharge, up to 90 days
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Recovery of kidney function defined as independence from renal replacement therapy at discharge.
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Assessed at hospital discharge, up to 90 days
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Duration of renal replacement therapy
大体时间:From initiation to discontinuation of RRT, assessed up to 28 days
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Total duration of renal replacement therapy during ICU stay, measured in days.
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From initiation to discontinuation of RRT, assessed up to 28 days
|
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In-hospital mortality
大体时间:From hospital admission to discharge, assessed up to 90 days
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All-cause mortality during hospital stay.
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From hospital admission to discharge, assessed up to 90 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- OXIRIS
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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