The Effect of Early Cytokine Absorption on the Systemic Inflammatory Response Syndrome and Organ Dysfunction in the First 48 Hours of Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cytokine response
研究概览
简要总结
The aim of the study is to investigate the effect of CytoSorb® treatment within the first 48 hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as monitored by leukocyte activation and inflammatory mediators.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Signs of hypoperfusion: serum lactate >2 mmol/L, low central venous oxygen saturation (ScvO2) (<70%) or high ScvO2 (>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 >6 mm Hg)
- •Hemodynamic support with vasopressors
- •Procalcitonin level ≥ 3 ng/ml
- •Invasive hemodynamic monitoring
- •Written informed content
排除标准
- •Patients under 18 years
- •Pregnancy (bHCG test positivity)
- •Surgical intervention in context with the septic insult
- •New York Heart Association IV heart failure
- •Acute coronary syndrome
- •Need for acute or chronic hemodialysis
- •Acute haematological malignancies
- •Cardiogenic shock
- •Post cardiopulmonary resuscitation care
- •Immunosuppression, systemic steroid therapy (>10mg prednisolon/day)
- •Human immunodeficiency virus infection (HIV) and active AIDS
- •Patients with donated organs
- •Thrombocytopenia (<20.000/ml)
- •More than 10%-of body surface area with third degree burn
结局指标
主要结局
Cytokine response
时间窗: First 48 hours of septic shock
Cytokine response: procalcitonin, C-reactive protein, interleukin-1, interleukin-1ra, interleukin-6, interleukin-8, interleukin-10, Tumor Necrosis Factor- α
Organ dysfunctions
时间窗: First 48 hours of septic shock
Organ dysfunctions: SOFA-scores, neurologic function (Glasgow coma scale), hemodynamic function (PiCCO parameters, ScvO2, lactate, dCO2), pulmonary function (gas exchange, pulmonary mechanics, Acute Respiratory Distress Syndrome classification (BERLIN)), renal function (KDIGO-, RIFLE-scores), gastrointestinal function (liver, GIT function, hematology (hemostasis, qualitative blood count)
次要结局
- Leukocyte function(First 48 hours of septic shock)
- Microcirculation(First 48 hours of septic shock)
研究者
Zsolt Molnár, MD, PhD, DEAA
Ph.D. student; Department of Anaesthesiology and Intensive Therapy
Szeged University