Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal: A Prospective Study.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 主要终点
- Haemodynamics
研究概览
简要总结
Severe acute pancreatitis (SAP) has a mortality of up to 42%. The outcome of SAP is related to the development of SIRS and consecutive organ failures. Due to the lack of a causative therapy except the removal of bile duct stones, therapy is predominantly symptomatic.
With regard to a marked inflammatory response ("cytokine storm") during the early phase of SAP extracorporeal cytokine removal is a promising therapeutic approach.
This prospective case control study investigates the impact of early extracorporeal cytokine adsorption with the CytoSorb®-device on haemodynamics (primary endpoint) and several secondary outcomes.
详细描述
Severe acute pancreatitis (SAP) has a mortality of up to 42%. The outcome of SAP is related to the development of SIRS and consecutive organ failures. Due to the lack of a causative therapy except the removal of bile duct stones, therapy is predominantly symptomatic.
Severity and mortality are associated to an early systemic inflammatory response syndrome (SIRS) and to septic complications at a later stage of disease.
With regard to a marked inflammatory response ("cytokine storm") during the early phase of SAP extracorporeal cytokine removal is a promising therapeutic approach.
This prospective case control study investigates the impact of early extracorporeal cytokine adsorption with the CytoSorb® device on haemodynamics (primary endpoint) and several secondary outcomes.
Patients with high probability of SAP (APACHE-II-score ≥10) are eligible for 7 days after the onset of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Proven acute pancreatitis:
- •typical pain
- •at least 3-fold increase in serum lipase
- •onset of pain within 7 days before inclusion AND
- •APACHE-II ≥10 AND
- •≥1 criterion of "severe sepsis" AND
- •Haemodynamic monitoring with transpulmonary thermodilution AND
- •≥ 1 marker of poor prognosis of acute pancreatitis:
- •Haematocrit > 44% (men), >40% (women)
- •Blood glucose > 125 mg/dL
- •C-reactive protein (CRP) > 10mg/dL
- •Computed tomography score category C-E
- •Age >55 years
- •Leukocytes >16 G/L
- •Glutamate oxaloacetate transferase (GOT) >250 U/L
- •Lactate dehydrogenase (LDH) >350 U/L
- •Calcium <2,0mmol/L
排除标准
- •pregnancy
- •lack of informed consent of patient or representative
- •pre-existing disease with life expectancy <3 months
结局指标
主要结局
Haemodynamics
时间窗: Within 48h after the onset of CytoSorb treatment
Improvement of the vasopressor dependency index \>=20%. (Improvement of cardiac power index \>=20% in case of no vasopressor use at baseline)
次要结局
- Mortality-1(28 days from inclusion into the study)
- Mortality-2(From admission to the ICU until discharge or transfer from the ICU (up to one year))
- Mortality-3(From admission to discharge from the hospital (up to one year))
- Inflammation(Within 48h after the onset of CytoSorb treatment)
- Respiratory outcome(Within 28 days after the onset of CytoSorb treatment)
- Renal function and its Change over time(Within 28 days after the onset of CytoSorb treatment)
研究者
Wolfgang Huber
Professor Dr. Wolfgang Huber
Technical University of Munich