Chronic Liver Failure
Conditions
Keywords
Acute
Brief summary
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:- 1. Complete clinical examination. 2. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels 3. BUN (Blood Urea Nitrogen) 4. Serum free fatty acid levels 5. Lipid profile. 6. Arterial ammonia 7. Arterial lactate 8. Blood sugar and serum insulin levels
Interventions
DRUGω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)
DRUGω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)
DRUGNo Lipid Emulsion/Placebo
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 5 days. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Metabolic parameter is a composite outcome of all the above said markers. |
| Influence of lipid infusion (w3/w6) on nitrogen balance. | 5 days | Improvement or deterioration in urinary urea nitrogen. |
| Incidence of sepsis and related complications | 28 days | — |
| Oxidative stress response to lipid infusion | 5 days | Oxidative stress response is based on the Improvement or deterioration in Isoprostane levels in urine |
| Influence of lipid infusion(w3/w6) on 28day mortality | 28 days | — |
| Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR). | 5 days | Effect is defined as INR (International Normalized Ratio) value within normal limit or improvement as compare to baseline value. |
Countries
India
Outcome results
None listed