NCT03844542Unknown不适用
Therapeutic Plasma Exchange in the Treatment of Sepsis Associated Multi-Organ Failure [SAMOF-TPE]
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- 28-Day Mortality
研究概览
简要总结
The investigators prospective, randomized adult clinical trial investigates the therapeutic efficacy of early therapeutic plasma exchange as adjunct treatment to standard therapy in patients with refractory septic shock and multiple organ failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •Adult patients are eligible for inclusion if they have sepsis with refractory shock and evidence of organ failure.
排除标准
- •Persons who are pregnant
- •Persons who are incarcerated
- •Acute surgical catastrophe without potential for intervention or source control
- •Cardiac arrest with unknown neurologic status, including patients being treated with therapeutic hypothermia
- •Presence of severe acute brain injury or severe dementia
- •Cardiogenic, neurogenic, obstructive, or post-cardiotomy shock
- •Acute pancreatitis with no established source of infection
- •Diabetic ketoacidosis as primary pathology
- •Note: Septic patients who develop DKA are eligible for inclusion. However, patients in whom organ dysfunction and hemodynamic instability are due primarily to volume depletion and acidosis from DKA should not be included.
- •Need for mechanical circulatory support
- •Prolonged acute illness with > 24 hours of pressor needs at enrollment and/or end organ damage with further care deemed to be "futile."
- •NOTE: The time resets if a new inciting event leads to SAMOF.
- •For example, if a patient has sepsis stabilized but requires operative intervention for source control within the initial 24 hours of admission and returns to the ICU with SAMOF, the patient is again eligible for randomization for the next 24 hours.
- •Bedbound state or poor baseline functional status with ECOG performance status score ≥ 3
- •Underlying terminal illness/malignancy with < 6 months life expectancy
- •Advanced chronic liver disease/cirrhosis with evidence of portal hypertension
- •HIV with HARRT non-compliance
研究组 & 干预措施
Therapeutic plasma exchange
Experimental
Perform therapeutic plasma exchange in addition to standard care for patients with sepsis induced multi-organ failure
干预措施: Therapeutic plasma exchange (Device)
Standard care alone for sepsis
No Intervention
Standard care for patients with sepsis induced multi-organ failure
结局指标
主要结局
28-Day Mortality
时间窗: 28 days
28 days
次要结局
未报告次要终点
研究者
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