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临床试验/NCT03866083
NCT03866083Unknown不适用

Safety and Efficacy of Extracorporeal Cytokine Hemoadsorption in Septic Shock in Critically Ill Cirrhotics -A Prospective Randomized Controlled Trial

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Reversal of shock in both groups

研究概览

简要总结

Patients with septic shock would be screened. Following this, patients meeting the inclusion and exclusion criteria will be screened and randomized to the two treatment groups. Standard criteria will be considered to define refractoriness to fluids. In all patients, baseline endotoxin activity assay and blood and urine sample will be stored for looking at the effect of therapy on these factors. Septic shock would be defined as clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP>=65 mm of Hg and having a serum lactate >2 mmol/L despite adequate volume resuscitation. Patients assigned to the treatment arm and who do not already have access for dialysis will have a standard hemodialysis catheter inserted in one of the femoral veins by the physician. Hemoperfusion will be carried out for one session within 12 hours for all randomized patient using the adsorption columns for Jianfan Biotechnology Co., Zhuhai, China). The hemoperfusion apparatus will be connected in front of the hemodialyzer in series. The procedure would be done for 2 hours without use of heparin with use of normal saline for pipeline flushing. In patients who also require hemodialysis the dialysis would subsequently be continued. Subsequent sessions of therapy would be done for patients (if required).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Critically ill cirrhotics with early onset septic shock (<24 hours) with norepinephrine of more than 10 ug/min and lactate >4 mmol/L.

排除标准

  • Patients with age less than 18 years
  • Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
  • Severe coagulopathy platelets <20,000 and INR >5
  • Active Bleed (Mucosal or variceal)
  • Pregnancy
  • Chronic kidney disease
  • Extremely moribund patients with an expected life expectancy of less than 24 hours
  • Failure to give informed consent from family members.
  • Hemodynamic instability requiring very high dose of vasopressors, late presentation or spontaneous reversal of shock
  • Patient enrolled in other clinical trials

研究组 & 干预措施

Extracorporeal Cytokine hemadsorption therapy

Experimental

Hemoperfusion will be carried out for one session within 12 hours for all randomized patient using the adsorption columns for Jianfan Biotechnology Co., Zhuhai, China). The hemoperfusion apparatus will be connected in front of the hemodialyzer in series.

干预措施: Extracorporeal Cytokine hemadsorption therapy (Drug)

Extracorporeal Cytokine hemadsorption therapy

Experimental

Hemoperfusion will be carried out for one session within 12 hours for all randomized patient using the adsorption columns for Jianfan Biotechnology Co., Zhuhai, China). The hemoperfusion apparatus will be connected in front of the hemodialyzer in series.

干预措施: Standard Medical Treatment (Drug)

Stadard Medical treatment

Active Comparator

Stadard Medical treatment

干预措施: Standard Medical Treatment (Drug)

结局指标

主要结局

Reversal of shock in both groups

时间窗: 72 hours

次要结局

  • Mortality in both groups(28 days)
  • Duration of mechanical ventilation in both groups(3 months)
  • Number of days in Intensive Care Unit stay in both groups(3 months)
  • Reversal of Acute Kidney Injury(5 days)
  • Lactate clearance in both groups(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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