Clinical Impact of Hemoperfusion With a Neutral Macroporous Resin Cartridge as Adjunctive Treatment in Septic Patients With Multiorgan Dysfunction Syndrome (MODS) Admitted to Intensive Care Units.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- IL-6 plasmatic concentration
研究概览
简要总结
Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with septic multiorgan dysfunction syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions:
- •Sepsis of abdominal origin with controlled infectious focus.
- •Noradrenaline dose> 0.5 µg / kg / min to maintain adequate organ perfusion after optimization of fluid therapy.
- •Dysfunction of two or more organs with SOFA ≥ 9 (5).
- •Blood lactate ≥ 2 mmol / L.
- •Procalcitonin (PCT)> 10 ng / mL.
- •CRP> 100 mg / L.
- •IL-6> 2000 pg / ml.
排除标准
- •Age under 18 years or over 80 years.
- •Pregnancy or breastfeeding.
- •Terminally ill patients or with a life expectancy of less than 48 hours.
- •Thrombocytopenia <60,000 / mm
- •Pancytopenia.
- •Severe coagulopathy with high risk of bleeding.
- •Inclusion in another research protocol.
- •In case of re-entry during the study period, only the first admission will be included.
- •Use of another haemoperfusion device.
结局指标
主要结局
IL-6 plasmatic concentration
时间窗: During hemoperfusion
Analyze the patient's variation of IL-6 plasmatic concentration during the hemoperfusion process
Adverse events
时间窗: During hemoperfusion
Analyze the presence of adverse events during the hemoperfusion process
Organ failure
时间窗: During hemoperfusion
Analyze the number and severity of failed organs during the hemoperfusion process
Vasopressors dose
时间窗: During ICU stay
Analyze the number of days on vasopressor support during ICU stay
Mean arterial pressure
时间窗: During hemoperfusion
Analyze the patient's variation of mean arterial pressure during hemoperfusion
Mechanical ventilation
时间窗: During ICU stay
Analyze the number of days on mechanical ventilation during ICU stay
Renal replacement therapy
时间窗: During ICU stay
Analyze the number of days on renal replacement therapy during ICU stay
ICU length of stay
时间窗: Post-Intensive Care Unit discharge
Analyze the patient's length of stay in ICU
ICU survival
时间窗: Post-Intensive Care Unit discharge
Analyze the patient's survival in ICU
Hospital stay
时间窗: post-hospital discharge
Analyze the patient's length of stay post-Intensive Care Unit discharge
Hospital survival
时间窗: Post-hospital discharge
Analyze the patient's survival post-hospital discharge
次要结局
未报告次要终点