THE IMMUNOLOGICAL EFFECTS AND METABOLIC TOLERANCE OF LIPID INFUSION IN PATIENTS WITH CIRRHOSIS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Effect of intravenous lipid on macrophages count.
研究概览
简要总结
The study will be an experimental pre-post trial in which patients with ethanol related liver disease (both severe alcoholic hepatitis and decompensated ) admitted in our institute from Jun 2013-Dec 2014 will be enrolled in the study. Those on ryle's tube feeding would receive polymeric blenderized kitchen based liquid diet while those tolerating orally would receive soft/ solid diet as tolerated as per requirement. All the patients would receive same amount of calories i.e., 30-35 kcal/kg ideal body weight/ day and 1-1.2 gm/kg protein. 35-40% of non protein calorie would be provided as fats and rest of the calories will be provided as carbohydrates. All patients will be transfused 250ml of 20% intra lipid per day for 3 consecutive days, over and above the feed provided to them to be taken enterally (orally or through Ryle's Tube). Patients will undergo tests prior to infusion and 72 hours after infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Subjects aged ≥ 18 years.
- •Patients with alcohol related liver disease (severe alcoholic hepatitis and decompensated cirrhosis)
- •Patients tolerating enteral nutrition.
排除标准
- •Active ongoing Gastrointestinal bleed.
- •Unresolved sepsis
- •Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
- •Co-morbidities like Diabetes mellitus, hyperlipidemia, Coronary Artery Disease (CAD) and hypothyroidism.
- •Renal failure (S.creatinine > 1.5mg %)
- •Pregnancy
- •Patients on high inotropic support (requiring more than 1 inotropic support)
- •Refusal to participate in the study
结局指标
主要结局
Effect of intravenous lipid on macrophages count.
时间窗: 3 days
Effect of intravenous lipid on monocytes counts.
时间窗: 3 days
Effect of intravenous lipid on neutrophils counts.
时间窗: 3 days
次要结局
- Influence of lipid infusion on PTT.(3 days)
- Influence of lipid infusion on arterial ammonia.(3 days)
- Influence of lipid infusion on interleukin levels (IL-6, IL-10).(3 days)
- Influence of lipid infusion on TNF-α (Tumor Necrosis Factor).(3 days)
- Influence of lipid infusion on PT/INR(3 days)
- Influence of lipid infusion on liver parameters.(3 days)
- Influence of lipid infusion on renal parameters.(3 days)
- Influence of lipid infusion on TEG (Thromboelastography)(3 days)