Endotoxin and Cytokine Adsorption Properties of the Oxiris Hemofilter in Septic Shock: Evaluation of Saturation Phenomena and Inflammatory Mediators' Clearance Capacity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Endotoxin adsorptive capacity of the Oxiris® membrane
研究概览
简要总结
This study examines how well the Oxiris® hemofilter works over time in adults with septic shock who require continuous kidney support in the intensive care unit (ICU).
Septic shock is a severe form of infection that leads to organ failure, including acute kidney injury. Many people with septic shock require continuous renal replacement therapy (CRRT), a form of dialysis that runs continuously to support the kidneys. The Oxiris® hemofilter is a special type of CRRT filter designed not only to replace kidney function but also to remove harmful substances from the blood, including endotoxins from bacteria and inflammatory proteins (cytokines).
Although Oxiris® is widely used, it is not known how long the filter continues to remove these substances effectively. Over time, the membrane of the filter may become filled with endotoxins and cytokines, which could reduce its ability to clean the blood. This study aims to determine whether and when this loss of adsorption occurs during a standard twenty-four-hour treatment period.
Adults with septic shock who receive Oxiris® as part of routine ICU care will take part in this observational study. No experimental treatment will be given. Blood samples will be taken before and after the filter, and fluid leaving the filter will be collected, to measure how endotoxins and cytokines are removed over time.
The study will also assess how changes in filter performance relate to clinical markers such as blood pressure support, blood lactate levels, organ function scores, kidney recovery, and twenty-eight-day survival.
The results will help define the optimal timing for Oxiris® filter replacement and support more effective use of blood purification therapy in patients with septic shock.
详细描述
This is a prospective, single-center, observational study designed to characterize the adsorption capacity and saturation dynamics of the AN69-polyethylenimine membrane (Oxiris® hemofilter) during continuous veno-venous hemofiltration (CVVH) in adult patients with septic shock.
The Oxiris® hemofilter is approved for continuous renal replacement therapy (CRRT) for up to 72 hours in patients with sepsis-associated acute kidney injury; however, in routine clinical practice the filter is commonly replaced after 12-24 hours because of concerns regarding declining adsorption efficiency. The biological basis for this practice remains insufficiently defined. This study aims to provide in vivo quantitative evidence on how endotoxin and cytokine adsorption by the Oxiris® membrane changes over time and whether cytokine clearance persists through convective transport when adsorption capacity is reduced.
The primary objective is to quantify the adsorption capacity of the AN69-polyethylenimine membrane for endotoxins and inflammatory mediators over a continuous 24-hour CVVH treatment period. Secondary objectives are to determine whether membrane adsorption efficiency declines over time in a manner consistent with saturation, to quantify cytokine clearance via convective transport into the effluent, and to evaluate whether reduced membrane adsorption is associated with clinical course and outcomes in septic shock.
Adult patients (≥18 years) with septic shock admitted to the intensive care unit of Pauls Stradiņš Clinical University Hospital will be enrolled. All patients will receive CVVH with the Oxiris® hemofilter as part of standard-of-care management. Eligibility requires fulfillment of Sepsis-3 septic shock criteria, a Dynamic Scoring System (DSS) score of 6-8, and treatment with CVVH for at least 24 hours. Baseline endotoxin concentration will be used to define the primary analytical cohort.
All patients will be treated using CVVH with the PrisMax platform and Oxiris® membrane under standardized conditions to ensure comparability of adsorption kinetics: blood flow 100-150 mL/min, filtration dose 25-30 mL/kg/h, regional citrate anticoagulation, replacement fluid 1000-1500 mL/h with 50% pre- and post-dilution, and net ultrafiltration of 0 mL/h.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •(should meet all the criteria mentioned below):
- •Septic shock patient with a Dynamic scoring system of 6-8 points /Septic shock definition based on Sepsis-3: a vasopressor requirement to maintain a mean arterial pressure of 65 mmHg or greater and serum lactate greater than 2mmol/L despite optimal (30ml/kg body weight) bolus fluid resuscitation/
- •CVVH with AN69-polyethylenimine (Oxiris) membrane for at least 24 hours
- •Age >18 years
排除标准
- •Age < 18 years
- •Pregnancy
- •Known contraindications to citrate anticoagulation
- •High likelihood of death within 24 hours due to irreversible comorbidities (e.g., end-stage cardiac, pulmonary, or hepatic disease; hepatorenal syndrome; advanced uncontrolled malignancy)
- •Simultaneous treatment with another adsorption device during the study period
研究组 & 干预措施
Oxiris CVVH Septic Shock Cohort
Adult patients with septic shock admitted to the intensive care unit and treated with continuous veno-venous hemofiltration (CVVH) using the Oxiris® hemofilter as part of standard-of-care therapy. All participants receive the same CRRT modality; no comparator or control group is included. The cohort is used to evaluate time-dependent endotoxin and cytokine removal, membrane adsorption performance, and cytokine convective clearance during a 24-hour Oxiris® treatment period.
干预措施: AN69-polyethylenimine hemofilter (Oxiris®) used for continuous veno-venous hemofiltration (CVVH) (Device)
结局指标
主要结局
Endotoxin adsorptive capacity of the Oxiris® membrane
时间窗: Baseline, and 1, 3, 6, 12 and 24 hours after initiation of CVVH with Oxiris®.
Endotoxin adsorption rate calculated from the difference between inlet (C\_in) and outlet (C\_out) endotoxin concentrations multiplied by plasma flow (Qp) and normalized to membrane surface area (U/cm²/min), reflecting true membrane adsorption.
Cytokine adsorptive capacity and cytokine clearance over time
时间窗: Baseline and 1, 3, 6, 12 and 24 hours after initiation of CVVH with Oxiris®.
Cytokine removal quantified by (i) total plasma clearance (from C\_in and C\_out), (ii) convective clearance (from effluent concentration × effluent flow), and (iii) adsorptive clearance (plasma clearance minus convective clearance), normalized to membrane surface area.
次要结局
- Hemodynamic changes associated with membrane adsorption performance(Baseline and 24 hours after initiation of CVVH with Oxiris®)
- Lactate changes associated with membrane adsorption performance(Baseline and 24 hours after initiation of CVVH with Oxiris®)
- Changes in Sequential Organ Failure Assessment score in relation to Oxiris® adsorption performance at 24 hours(Baseline and 24 hours after initiation of CVVH with Oxiris®)
- Inflammatory marker (C-reactive protein) response associated with membrane adsorption performance(Baseline and 24 hours after initiation of CVVH with Oxiris®)
- Inflammatory markers (Procalcitonin) response associated with membrane adsorption performance(Baseline and 24 hours after initiation of CVVH with Oxiris®)
- Inflammatory mediator (Interleukin-6) response associated with membrane adsorption performance(Baseline and 24 hours after initiation of CVVH with Oxiris®)
- 28-day mortality(From initiation of CVVH to Day 28.)