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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:-
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ω3 PUFA(10% Omegavan 100 ml) | Experimental |
| |
| ω6 PUFA (20% Intralipid 50 ml) | Experimental |
| |
| Placebo Arm | Placebo Comparator | No Lipid Emulsion will be given in this arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml) | Drug |
| ||
| ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of intravenous lipid emulsions (w3/ w6) on systemic inflammation and endotoxemia levels at the end of 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 | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of sepsis and related complications | 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. | Metabolic parameter is a composite outcome of all the above said markers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Anand Kulkarni V, MD | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Drug |
|
| No Lipid Emulsion/Placebo | Drug |
|
| 5 days |
| Influence of lipid infusion (w3/w6) on nitrogen balance. | Improvement or deterioration in urinary urea nitrogen. | 5 days |
| Effect of lipid infusion (w3/w6) on International Normalized Ratio (INR). | Effect is defined as INR (International Normalized Ratio) value within normal limit or improvement as compare to baseline value. | 5 days |
| Oxidative stress response to lipid infusion | Oxidative stress response is based on the Improvement or deterioration in Isoprostane levels in urine | 5 days |
| Influence of lipid infusion(w3/w6) on 28day mortality | 28 days |
| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D005231 | Fatty Acids, Unsaturated |
| C545823 | soybean oil, phospholipid emulsion |
| ID | Term |
|---|---|
| D005227 | Fatty Acids |
| D008055 | Lipids |
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