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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 28-day all-cause mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients under 18 years of age
- •Chronic dialysis prior to ICU admission
- •Missing key clinical data
- •Patients not meeting criteria for septic shock
研究组 & 干预措施
Oxiris Group
Patients with septic shock requiring renal replacement therapy treated with the Oxiris filter.
干预措施: Oxiris filter (Device)
Standard Filter Group
Patients with septic shock requiring renal replacement therapy treated with standard hemofilters.
干预措施: Standard Hemofilter (Device)
结局指标
主要结局
28-day all-cause mortality
时间窗: Up to 28 days
All-cause mortality within 28 days from the initiation of renal replacement therapy.
次要结局
- ICU length of stay(From ICU admission to ICU discharge, assessed up to 28 days)
- Renal recovery(Assessed at hospital discharge, up to 90 days)
- Duration of renal replacement therapy(From initiation to discontinuation of RRT, assessed up to 28 days)
- In-hospital mortality(From hospital admission to discharge, assessed up to 90 days)