To Study the Immunomodulating Effects and Safety Profile of ω3 and ω6 PUFA Containing Intravenous Lipid Emulsion in Patients With Acute on Chronic Liver Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days.
研究概览
简要总结
Study population: Patients admitted or seen in OPD (Out Patient Department), Department of Hepatology.
Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017 Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml).
Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml).
Group C -Placebo group
Monitoring and assessment- :- The following tests will be done in these patients:-
- Complete clinical examination.
- Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels
- BUN (Blood Urea Nitrogen)
- Serum free fatty acid levels
- Lipid profile.
- Arterial ammonia
- Arterial lactate
- Blood sugar and serum insulin levels
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute on Chronic Liver Failure (ACLF) patients aged 18 years and above
- •Patients tolerating enteral nutrition
- •Patients with no overt sepsis - no fever, sterile blood and urine cultures, procalcitonin <2
排除标准
- •Active ongoing GI bleed
- •Allergy to soya oil, eggs, peanuts or other ingredients of intralipid.
- •Co-morbidities like Diabetes mellitus, hyperlipidemia, CAD and hypothyroidism.
- •Renal failure (S.creatinine > 2.5mg%)
- •Pregnancy
- •Patients with shock requiring vasopressor support
- •Patients on anticoagulants
- •Refusal to participate in the study
研究组 & 干预措施
ω3 PUFA(10% Omegavan 100 ml)
干预措施: ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml) (Drug)
ω6 PUFA (20% Intralipid 50 ml)
干预措施: ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml) (Drug)
Placebo Arm
No Lipid Emulsion will be given in this arm
干预措施: No Lipid Emulsion/Placebo (Drug)
结局指标
主要结局
Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days.
时间窗: 5 days
Decrease in endotoxins levels , TNF alpha,ilnterleukin 6,ilnterleukin 10,Monocyte/ macrophage activation etc. All of them are markers of inflammation. The outcome systemic inflammation is a composite outcome which includes all the above mentioned markers
次要结局
- Incidence of sepsis and related complications(28 days)
- Influence of lipid infusion (w3/w6) on nitrogen balance.(5 days)
- Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR).(5 days)
- Oxidative stress response to lipid infusion(5 days)
- Influence of lipid infusion(w3/w6) on 28day mortality(28 days)
- Effect of lipid infusion (w3/w6) on metabolic parameters viz., serum triglyceride levels, serum ketone levels, free fatty acid levels and arterial lactate levels.(5 days)