Plasma Exchange in Acute on chronic Liver Failure: A Randomized Control Trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- To study the effect of Plasma Exchange (PE) on 28-day mortality in patients with ACLF.
研究概览
简要总结
• Liver transplant remains a limited resource and therefore there is unmet need for alternative therapies Persistent or incident hyperammonemia is more frequent in ACLF and is a risk factor for developing new onset organ failure and mortality. Therapeutic plasma exchange can lowers ammonia level in patients of ACLF and can improve survival over standard medical management.
• Plasma exchange, by eliminating accumulated toxins (e.g., DAMPs) in ACLF can facilitate recovery of the failing liver and improvement in SIRS.
• Replacement of the coagulation factors and other proteins and hence replacing the metabolic functions of the failing liver.
• PE also leads to immunomodulation like shift toward TH2 balance, suppression of IL2 and IFN – Y production, reduction of inflammatory cytokines – TNF alpha and IL – 8 and helps in improvement of SIRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Written informed consent.
- •2.18 – 60 years of age 3.EASL-ACLF grade 1, 2 and 3.
排除标准
- •1.Systolic blood pressure < 90 mm Hg 2.Lack of informed consent 3.Coexisting severe illness e.g., coronary artery disease, malignancy etc 4.Post Liver Transplant patients 5.Pregnancy 7.Active infection- bacterial or fungal.
- •8.Hepatocellular carcinoma 9.Patient who dies within 48 hrs of admission.
结局指标
主要结局
To study the effect of Plasma Exchange (PE) on 28-day mortality in patients with ACLF.
时间窗: 28 days
次要结局
- 1) To study the effect of PE on APASAL ACLF Research Consortium (AARC) score, CLIF-C ACLF score, Acute Physiology and Chronic Health Evaluation (APACHE) II, and Systemic Inflammatory Response Syndrome (SIRS).(2) To study the effect of PE on the resolution or development of organ failures in ACLF.)