NCT02719210已完成不适用
High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure-A Prospective Pilot Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Transplant free Survival.
研究概览
简要总结
All the children with acute liver failure who are candidates for transplant but have constraints for transplant will be randomized either to receive standard medical therapy or high volume plasma exchange along with standard medical therapy with the aim to assess the effect of high volume plasma exchange on transplant free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ≥ 10kg with ALF with INR ≥ 4 or INR ≥ 3 with Hepatic Encephalopathy.
排除标准
- •Evidence of active infection (Age specific neutrophilic leucocytosis (ANC) and procalcitonin ≥ 2 and/or focus of active infection
- •Refusal of consent or assent (annexure 3)
- •Liver resections with liver failure
- •Patients with clinical suspicion of irreversible brain injury
- •Patients with acute kidney injury
研究组 & 干预措施
High Volume Plasma Exchange with Standard Treatment
Experimental
干预措施: High Volume Plasma Exchange (Biological)
Standard Treatment
Active Comparator
Standard Treatment is defined as anti raised Intra-cranial pressure
- Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure).
- Mannitol
- Hypertonic 3% Saline
干预措施: Hypertonic 3% saline (Drug)
Standard Treatment
Active Comparator
Standard Treatment is defined as anti raised Intra-cranial pressure
- Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure).
- Mannitol
- Hypertonic 3% Saline
干预措施: Mannitol (Drug)
Standard Treatment
Active Comparator
Standard Treatment is defined as anti raised Intra-cranial pressure
- Elective positive pressure ventilation in hepatic encephalopathy grade 3 or 4 and in those with features of raised ICP (Intra-cranial pressure).
- Mannitol
- Hypertonic 3% Saline
干预措施: Elective positive pressure ventilation (Device)
结局指标
主要结局
Transplant free Survival.
时间窗: 7 days
Transplant free survival
时间窗: 30 days
次要结局
- Incidence of organ dysfunction (other than liver and Central Nervous System).(30 days)
- Number of organs (other than liver and CNS) affected in children with organ dysfunction.(30 days)
- Incidence of High Volume Plasma Exchange related complications- Major/Minor.(within 1 month)
- Change in hemodynamic parameters and Hepatic Encephalopathy (HE) before and after in the High Volume Plasma Exchange group.(5 days)
- Survival after liver transplant with or without High Volume Plasma Exchange.(30 days post procedure)
- Change in Laboratory parameters - Bilirubin, INR and Ammonia in control group.(0 day)
- Change in Laboratory parameters - Bilirubin, INR and Ammonia- in control group.(5 day)
- Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in HVPE arm from baseline till within 24-hours of the last session of High Volume Plasma Exchange.(within 24-hours of the last session of High Volume Plasma Exchange)
- Change in the levels of IL-6 and TNF alpha (Tumor Necrosis Factor) in control arm from baseline till 5 days.(5 days)
研究者
研究点 (1)
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