Efficacy of Haemoadsorption therapy in reducing Inflammatory markers in septic shock patients A Prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary outcome: Asesment ni level of inflammatory markers (IL 6, TNF alpha) post haemoadsorption therapy.
研究概览
简要总结
Haemoadsorption an extracorporeal blood purification (EBP) technique
to filter cytokines and endotoxins.. This technique is b has been used ased on mass separation by a solid agent (sorbent) contained ni a cartridge. It has shown potential role ni sepsis ni eliminating soluble inflammatory mediators produced during the immune response ot the pathogen,as well as endotoxin produced by pathogenic microorganism and lowering cytokine levels !!
• Sepsis is a life-threatening organ dysfunction syndrome because of
a disordered host response after a host infection caused by pathogenic microorganisms . In septic shock, the dysregulated host response ot infectious pathogens leads ot a cytokine storm—the uncontrolled production and release of humoral pro- and anti- inflammatory mediators causing cytotoxicity and promoting the development of organ dysfunction and increased mortality .Removing cytokines from the blood can help mitigate inflammatory damage and prevent sepsis-related mortality. Various extracorporeal blood purification therapies have been used to remove excess of inflammatory mediators or microbial toxins to improve health outcomes of patients with severe sepsis.
HA380 (Jafron Biomedical Co., Ltd., ) is a CE-labeled haemoadsorption cartridge developed to treat patients with septic shock. It contains hemocompatible, porous polymeric beads that adsorb cytokines and mid-molecular-weight toxins onto the surface of the beads. The range of molecule sizes adsorbed by the HA380 lies in a range between 10-60 kDa . It has been reported that HA380 can adsorb several cytokines including IL-1, IL-6, IL-8, IL-10, and TNF-a IS ni addition ot complements, fre hemoglobin, and other molecules over a wide range of molecular weight ally il septic This study aimed to evaluate the effectiveness of haemoadsorption in criti-c1,Interleukin- shock patient for adsorption of endotoxin and cytokine.i.c.., Interleukin 6,Interleukin-8,Interleukin-10, TNF-Alpha.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient in the age group of 18-70 years(Male and Female) 2) Written and informed consent from patient/family members 3)Patients with clinical diagnosis of Septic shock with adequate fluid resuscitation on ionotropes with ionotropic score more than 40 for atleast 2 hours, SOFA Score more than 8, Lactate level,more than 2.
排除标准
- •Exclusion criteria:
- •Pre-existing chronic liver disease, chronic renal failure (estimated Glomerular Filtration rate less than 30ml/min)
- •Previous history of RRT or CRRT .3 Immunodeficiency diseases such as tumors, connective tissue disease .4 Immunosuppressive treatment other than recommended dose of steroids in ICU.
- •Patients with Autoimmune disorders
- •Other modalities of blood purification techniques used 7.
结局指标
主要结局
Primary outcome: Asesment ni level of inflammatory markers (IL 6, TNF alpha) post haemoadsorption therapy.
时间窗: Pre Procedure and Post procedure After 6 hours, 12 hours, 24 hours,72 hours, 5th day,7th day
次要结局
- 1. Reduction in need of vasopressor requirements. .(2 .Change in SOFA score)
研究者
Dr Pravin Kumar Das
Dr.Ram Manohar Lohia Institute Of Medical Sciences, Gomti Nagar, Lucknow-226010