Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- SOFA score
研究概览
简要总结
The goal of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoperfusion using the Efferon® LPS device in combination with hemofiltration (HF) / hemodiafiltration (HDF), with the goal of reducing the severity of organ dysfunction (measured by SOFA score) in patients with acute pancreatitis.
Participants will be assigned to two groups for comparison: a control group receiving baseline therapy with HF/HDF, and a treatment group receiving baseline therapy in combination with HF/HDF and Efferon® LPS hemoadsorption.The therapy will be initiated within the first 24 hours after ICU admission and within 8 hours after patient enrollment.
详细描述
Acute pancreatitis remains a life-threatening disorder with a considerable risk of unfavorable outcomes. In patients with severe acute pancreatitis (SAP), hospital mortality ranges from 16% to 20% and may rise to 60% in cases complicated by multiple organ dysfunction (MOD). Progressive MOD, arising from systemic inflammatory response syndrome (SIRS), represents the principal cause of early death. Recently, extracorporeal blood purification techniques, including hemoperfusion, have emerged as valuable adjuncts to intensive care, providing opportunities to correct derangements in homeostasis.
In recent years, extracorporeal blood purification methods, including hemoperfusion, have become one of the components of intensive care, allowing for correction of homeostatic parameters.
The Efferon® LPS device was originally developed for use in sepsis, utilizing its ability to effectively target both primary and secondary inflammatory mediators. However, this approach also has significant potential for the treatment of acute pancreatitis, a condition characterized by a similarly complex inflammatory response.
The goal of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoperfusion using the Efferon® LPS device in combination with hemofiltration/hemodiafiltration, with the goal of reducing the severity of organ dysfunction in patients with acute pancreatitis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≤ 5 days from the onset of acute pancreatitis
- •Acute pancreatitis of moderate or severe according to the Atlanta classification (2012)
- •Acute pancreatitis confirmed by tomography. Modified CTSI Pancreatitis Severity Index Score ≥ 4 points
- •APACHE II > 8
- •≥ 2 points on the Sequential Organ Failure Assessment (SOFA) scale and/or ≥ 2 criteria of Systemic Inflammatory Response Syndrome (SIRS):
- •Body temperature ≥ 38 °C or ≤ 36 °C
- •Heart rate ≥ 90/min
- •Respiratory rate ≥ 20/min or hyperventilation with PaCO₂ ≤ 32 mmHg
- •Leukocytosis (≥ 12,000/μl) or leukopenia (≤ 4,000/μl) or left shift of leukocyte formula
排除标准
- •SOFA score > 12 points
- •Presence of an uncontrolled surgical infection focus
- •Development of septic complications - signs of infection
- •Acute pancreatitis as an exacerbation of chronic pancreatitis
- •Blood triglyceride level > 1000 mg/dL (11.2 mmol/L)
- •Liver cirrhosis (> 6 points by Child-Pugh classification)
- •Unresolved biliary hypertension syndrome
- •Chronic kidney disease stage 4-5
- •Acute pulmonary embolism confirmed by CT
- •Acute myocardial infarction within the last 4 weeks
- •Acute cerebrovascular accident
- •Severe congestive heart failure
- •Uncontrolled bleeding (acute blood loss within the last 24 hours)
结局指标
主要结局
SOFA score
时间窗: 1-7 days
The Sequential Organ Failure Assessment (SOFA) score is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall score, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. With a score of no more than 12, multiple organ dysfunctions are assumed, 13-17 points indicate the transition of dysfunction to insufficiency, a score of about 24 indicates a high probability of death. The lower the SOFA score, the less pronounced organ failure and the better the patient's survival prognosis.
次要结局
- Vasopressor free days(1-14 days)
- Horovitz oxygenation index(1-14 days)
- Cardiac index(1-72 hours)
- Length of stay in the intensive care unit(1-60 days)
- Mechanical ventilation duration(1-28 days)
- Renal replacement therapy (RRT) duration(1-28 days)