Official Title: Effect of oXiris Hemofilter Use in Septic Shock: A Multicenter Retrospective Cohort Study Using a Target Trial Emulation Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- In-hospital Mortality
研究概览
简要总结
This study aims to evaluate the clinical effectiveness of the oXiris® hemofilter in patients with septic shock and acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT). While some studies suggest that oXiris® may improve hemodynamic stability by removing endotoxins and cytokines, its impact on survival remains inconsistent.To provide more reliable causal evidence, this multicenter retrospective cohort study utilizes a Target Trial Emulation (TTE) approach. The study will compare patients treated with the oXiris® filter to those treated with standard CRRT filters, focusing on in-hospital mortality and other clinical outcomes such as fluid balance and vasopressor requirements.
详细描述
Background:
Septic shock is characterized by a dysregulated host response to infection, leading to a "cytokine storm" that causes organ dysfunction and hemodynamic instability. Extracorporeal blood purification (EBP) using the oXiris® filter is designed to restore immune homeostasis by adsorbing both endotoxins and cytokines while performing standard CRRT functions. However, existing observational data often suffer from selection and immortal time biases.
Study Design and Methodology:
This study employs the Target Trial Emulation (TTE) framework to mimic the design of a randomized controlled trial using retrospective observational data.
- Target Population: Adult patients (≥19 years) admitted to the ICU with septic shock and AKI requiring CRRT between March 2021 and August 2025.
- Time Zero: Defined as the initiation of CRRT.
- Treatment Strategies:
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older.
- •Admitted to the ICU with septic shock (Sepsis-3 criteria) between March 2021 and August
- •Required Continuous Renal Replacement Therapy (CRRT) due to acute kidney injury (AKI).
排除标准
- •Death or withdrawal of life-sustaining therapy within 48 hours of ICU admission.
- •Patients with End-Stage Renal Disease (ESRD).
- •Patients with missing critical covariates.
研究组 & 干预措施
oXiris Group
Patients with septic shock and acute kidney injury (AKI) who initiated continuous renal replacement therapy (CRRT) using the oXiris® hemofilter at Time zero. Data for this cohort are collected from five tertiary medical centers in South Korea. The oXiris® filter is used for its combined functions of cytokine adsorption, endotoxin removal, and standard CRRT.
Control Group (Standard CRRT)
Patients with septic shock and AKI who initiated CRRT using a standard (non-adsorptive) hemofilter at Time zero. This cohort is identified and extracted from the Korea Sepsis Alliance (KSA) registry, a multicenter prospective sepsis cohort in South Korea. These patients receive standard-of-care CRRT without specific hemoadsorption properties.
结局指标
主要结局
In-hospital Mortality
时间窗: From the initiation of CRRT (Time zero) until hospital discharge or death.
The primary objective is to evaluate the causal effect of oXiris® hemofilter use on survival during the hospital stay compared to standard CRRT. Statistical analysis will be performed using an Inverse Probability of Treatment Weighting (IPTW)-weighted Cox proportional hazards model to adjust for baseline and time-varying confounders.
次要结局
- 3-day Cumulative Fluid Balance(3 days after CRRT initiation.)
- Time to Vasopressor Weaning(From CRRT initiation through ICU discharge, up to 28 days)
- Organ Dysfunction Improvement(Baseline (Day 0) and Days 1, 2, 3, 7 of ICU stay.)
- Changes in Inflammatory Markers(Baseline (Day 0) and Days 1, 2, 3, 7 of ICU stay.)
- Renal Recovery Status(From CRRT initiation through hospital discharge, up to 90 days)
研究者
LIM SUNG YOON
Associate professor
Seoul National University Bundang Hospital