A Multiple Centre, Cohort Study of New Continuous Renal Replacement Therapy (CRRT) Membranes oXiris for Patients With Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 590
- 试验地点
- 2
- 主要终点
- 28-day mortality
研究概览
简要总结
The objectives of this study are to determine whether Continuous Renal Replacement Therapy (CRRT) with oXiris in patients with septic shock would improve clinical outcomes such as the sepsis-related organ failure assessment (SOFA) , hemodynamic, mortality compared CRRT with conventional membrane.
详细描述
Sepsis is the leading cause of death in ICU, resulting in multi-organ failure in critically ill patients. Patients with septic shock combined sepsis-associated Acute kidney injury (AKI)have even poorer outcome.
Endotoxin activity, inflammation and immune dysfunction, have been consider relevant to their pathogenesis of sepsis. High levels of Inflammation are associated with worse clinical outcomes. However, all studies of anti-inflammation treatment in sepsis patient are failed and anti-inflammation treatment of sepsis still remains controversial.
oXiris is a new filter with adsorptive membrane, which removes endotoxin and inflammatory mediator from plasma. But current evidence of oXiris is limited, and only some small sample studies have proved that it can improve the haemodynamics and the sepsis-related organ failure assessment(SOFA) score.
Our hypothesis was that oXiris would be associated with better clinical outcomes, such as decreased SOFA score, improved survival rate, better hemodynamic, and improved of organ function.
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
- •>18 Years
- •Treated by CRRT using oXiris or conventional membrane
- •SOFA cardiovascular Score ≥ 3
- •Septic shock due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection)
- •Written informed consent
排除标准
- •Chronic Kidney Disease
- •Renal replacement therapy (RRT) in the last 30 days
- •Pregnancy
- •Immunosuppressive treatment or steroids (prednisone > 0.5 mg/kg/day or equivalent).
- •Autoimmune disorder.
- •Transplant receptor.
- •Inclusion in other ongoing studies within the last 30 days.
- •Coexisting illness with a high probability of death
结局指标
主要结局
28-day mortality
时间窗: 28 days
28-day mortality
The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours
时间窗: 72 hours after Continuous Renal Replacement Therapy initiation
The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours(Scores Range 0-4, higher values represent a worse outcome)
次要结局
- Changes of Sepsis-related Organ Failure Assessment(SOFA) Score(72 hours after Continuous Renal Replacement Therapy initiation)
- Total length of Continuous Renal Replacement Therapy(Day 28)
- VIS-Norepinephrine dose or equivalent(72 hours after Continuous Renal Replacement Therapy initiation)
- Lactate concentration at 72 hours(72 hours after Continuous Renal Replacement Therapy initiation)
- mechanical ventilation free days(Day 28)
- Change of Norepinephrine dose Over Time(72 hours after Continuous Renal Replacement Therapy initiation)
- Vasopressor-free days(Day 28)
- ICU mortality(through study completion, an average of 1 month)
研究者
Songqiao Liu
Prof.
Southeast University, China