Comparing Cytokines, Toxins Adsorbing oXiris Filter to ST150 Filter During CRRT in Patients With Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- endotoxin level in blood
研究概览
简要总结
The Oxiris® filter is a registered product for CRRT already safely used in routine care.
In in vitro experiments, the Oxiris® filter has been demonstrated to adsorb endotoxin and cytokines. Compared to conventional filters this may be advantageous in patients with severe sepsis but neither decreased levels of endotoxin and cytokines nor an improved outcome has been demonstrated with clinical use.
But there are so far little clinical data on the oXiris® filter on humans. The oXiris® filter will be investigated in a double blind randomized crossover setting against a traditional filter (ST150). Either filter will be used for 24 hours after which it will be changed to the opposite filter for another 24 hours.
Arterial blood samples will be drawn at start and then 1, 3, 8, 16 and 24 hours after the start of each filter, and analyzed for endotoxin (EAA assay), TNF-α, IL-1β, IL-6 and IL-10 (ELISA) levels. Standard blood tests will be analyzed simultaneously. Data concerning mode and settings of CRRT, heart rate, blood pressure, medication, data concerning ventilatory support and pathogen will be registered.
Primary endpoint: Levels of endotoxin and cytokines will be compared using Student's paired t-test on AUC values for each 24-hour period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients admitted to intensive care unit (ICU) of age >18 years with decision based on the clinical situation of the patient taken by the physician in charge that continuous renal replacement therapy will be started.
- •Vasoconstrictor and volume dependent septic shock with known Gram-negative infectious agent in blood culture.
- •Vasoconstrictor and volume dependent septic shock suspected to be caused by a Gram-negative agent and with positive plasma endotoxin test.
排除标准
- •Infected with Hepatitis B or C or HIV.
- •Dependence on dialysis treatment before the actual ICU episode.
研究组 & 干预措施
oXiris
Continuous renal replacement therapy with filter that adsorbs cytokines/toxins.
干预措施: oXiris (Device)
ST150
Continuous renal replacement therapy with filter that does not adsorb cytokines/toxins.
结局指标
主要结局
endotoxin level in blood
时间窗: change from baseline to 48 hours
Describes the load of toxins from the septic state. Higher load means increased impact from the infectious state mediated through the septic shock. Expected mean differences in endotoxin levels including standard deviation is based on data from a previous study on extracorporeal endotoxin removal in sepsis patients (reference 1).
次要结局
- mean blood pressure(hourly up to 48 hours)
- IL-1β level in blood(change from baseline to 48 hours)
- IL-6 level in blood(change from baseline to 48 hours)
- TNF-α level in blood(change from baseline to 48 hours)
- IL-10(change from baseline to 48 hours)
研究者
Marcus Broman
M.D. Ph.D.
Skane University Hospital